The effect of food supplements on completely edentulous women rehabilitated with complete dentures: A randomized controlled trial

Abstract

Aim:

Neglected oral health is a major issue, especially in women of developing countries, leading to early loss of teeth which may further lead to malnutrition, degradation of overall health, and increased chances of osteoporosis. Thus, the aim of this study was to assess the effect of food supplement on masticatory performance, nutritional status, electromyography (EMG) (masseter and temporalis), and bone mineral density (BMD) among women rehabilitated with complete denture.

Settings and Design:

Hospital based randomized controlled trial.

Materials and Methods:

A randomized controlled trial with 106 women of 45–65 years rehabilitated with complete denture (56 received food supplement and 50 did not receive food supplement) and 52 healthy control was conducted. The outcomes were assessed at baseline and 3 and 6 months of follow up (after complete denture fabrication). Outcomes were measured via masticatory performance, nutritional status (hemoglobin, serum calcium, albumin, and Vitamin D level), EMG of masseter and temporalis muscles, and BMD.

Statistical Analysis Used:

Friedman’s analysis of variance test was used as a nonparametric test, and the Statistical Package for the Social Sciences version 21.0 at a significance level of 0.05 was used for statistical analysis.

Results:

A statistically significant change was observed during follow up for the group with food supplement for BMD, EMG, and masticatory performance. When biochemical parameters were assessed during follow up, no statistically significant change was observed for both groups (with and without food supplement), except for serum calcium level in group which received food supplement.

Conclusion:

It was found that the magnitude of effect was remarkably meager in food supplement group which could be perhaps due to less time given for follow up period. Longer duration of trials would yield better results.

INTRODUCTION

The World Health Organization considered loss of natural tooth or edentulism a disability, which not only affects oral and general health status but also affects quality of life.[1] Although it is an important aspect, it is still an often-overlooked or neglected public health issue, especially for women.[2] Edentulism causes poor chewing efficiency which ultimately leads to malnutrition, degradation of overall health, and increased chances of osteoporosis apart from marked hormonal and metabolic alteration due to menopause influencing calcium metabolism among women, thus leading to osteoporosis.[3] Edentulism is not only responsible for low food intake but also related to selective food consumption, especially with development of a tendency toward intake of soft diet resulting in unbalanced diet or undernourishment. Soft food usually is rich in fat and has low content of micronutrients.[4] There is a decreased intake of protein-rich diet, fruits, and vegetables leading to nutritional deficiency, dietary inadequacies, and debilitation.[5]

With loss of teeth, there is loss of neuromuscular control of the masticatory apparatus. Masticatory apparatus is involved in crushing of food particles into simpler form, which is helped by various facial muscles. Out of several factors, edentulism is one major factor, which affects masticatory performance and a decrease in masticatory performance has been reported in completely edentulous subjects.[6] Electromyography (EMG) of masticatory muscles (like masseter and temporalis) during masticatory movement is important to know effect on chewing cycle but has not been studied for completely edentulous women extensively. A decrease in EMG activity in osteoporotic dentate females was observed in one of the studies.[7] This decrease in masticatory performance in completely edentulous subjects leads to decreased intake of a variety of foods leading to malnutrition,[8] but yet none of the studies has correlated masticatory performance and nutritional status in completely edentulous women.

Thus, the aim of this study was to find out the effect of food supplement in completely edentulous women rehabilitated with complete denture on their masticatory performance, nutritional status, EMG (masseter and temporalis), and bone mineral density (BMD). It was hypothesized that rehabilitation of oral health with complete denture and use of food supplement in edentulous women might improve their overall health and also help in preventing osteoporosis.

MATERIALS AND METHODS

Study design

The study was a parallel-group randomized controlled trial with blinding of participants and outcome assessor. The institutional ethic committee approved the study (977/R cell-11), and the trial was registered in the Clinical Trials Registry of India with registry number CTRI/2014/10/005112. The study was conducted at a tertiary care center in the northern part of India after taking written informed consent from participants. Randomization was done using computer-generated random number (simple randomization) into with and without food supplement group (by author NS). Control group included matched complete dentate females. Allocation concealment was done using sequentially numbered opaque-sealed envelopes. The author (KK) did enrollment of patients, and another author (MK) assigned participants to different groups. All randomized participants were rehabilitated with tissue-supported removable complete dentures. Participants who were given food supplement were not allowed to discuss their treatment with another group. Outcome assessor (SK) was not aware of the treatment given to patients. Sample size was calculated by using ClinCalc using alpha 1%, power of 80%. Reporting guideline for this study is Consolidated Standards of Reporting Trials (CONSORT).

Participants

Female edentulous patients visiting the department of prosthodontics for fabrication of denture were enrolled after fulfilling inclusion and exclusion criteria.

Inclusion criteria

1. Females in the age range of 45–65 years

2. Class I complete edentulous cases (between 2 and 6 months of edentulism)[9]

3. No history of partial/complete denture wearing

Exclusion criteria

1. Any systemic or infectious disease/malignancy

2. Orofacial motor disorder

3. Osteoporosis

4. Taking any food supplement or any kind of restrictions in the diet

5. Psychiatric disorder/dementia, etc.

Exclusion criteria were based on history/medical records of patients. Female attendants with participants who fulfilled all inclusion and exclusion criteria but had all teeth were included as matched control. Matched control participants were subjected to all investigations (nutritional, EMG, masticatory performance, and BMD) after taking written informed consent.

Intervention

Out of 181 recruited participants, 158 (56 and 50 participants received food supplement or not, respectively, and 52 attendants were healthy matched control) were finally included in the study. Thirty-one participants were excluded as they did not meet the required inclusion criteria. All participants went through the process of fabrication of tissue-supported complete denture and their basic sociodemographic and clinical characteristics were recorded. Participants in food supplement group were advised food supplement (Geria Gold Saffron, Hexagon Nutrition) 1 sachet (25 g) in a lukewarm water (glass of water of 200 mL) per day for 3 months. The composition of food supplement is presented in Supplementary Table 1. This food supplement was chosen as it matched the nutritional components recommended by National Institute of Nutrition, Hyderabad, and approved by funding agency. Other intervention group did not receive any food supplement. After 2 weeks of complaint-free period from postinsertion, baseline values of outcomes were recorded inclusive of biochemical investigations for nutritional outcome (albumin [ALB], hemoglobin, Vitamin D, and calcium); surface EMG of masseter and temporalis muscle; masticatory performance using fractional sieving method; and BMD by dual-energy X-ray absorptiometry (DEXA). Follow-up recording of outcomes was done at 3 and 6 months after baseline recording.

Supplementary Table 1.

Composition of food supplement

Nutritional facts	Units	Per 100 g powder (approximate)	Per serving 25 g powder (approximate)
Caloric content	kcal/kJ	457/1913	114/478
Calories from fat	kcal/kJ	153/641	38/160
Nutrients
Total carbohydrates	g	55	13.75
Dietary fiber	g	1	0.25
Sugar	g	0	0
Protein	g	21	5.25
Total fat	g	17.00	4.25
Saturated fats	g	10.57	2.64
Monounsaturated fatty acid	g	4.28	1.07
Poly unsaturated fatty acid	g	0.71	0.18
Trans fat	g	0	0
Cholesterol	mg	0	0
Vitamins
Vitamin A	IU	2000	500
Vitamin D	IU	200	50
Vitamin C	mg	40	10
Vitamin E	mg	10	2.5
Niacinamide	mg	10	2.5
Vitamin B2	mg	3	0.75
Vitamin B6	mg	2	0.5
Vitamin B1	mg	1.2	0.3
Folic acid	µg	200	50
Vitamin K	µg	70	17.5
Vitamin B12	µg	2	0.5
Minerals
Calcium	mg	600	150
Phosphorus	mg	475	119
Magnesium	mg	200	50
Iron	mg	14	3.5
Zinc	mg	10	2.5
Iodine	µg	75	19
Herbal extract
Dry extracts equivalent to
Glycyrrhiza glabra	mg	2000	500
Withania somnifera	mg	2000	500

The clinician (BPS) having 8 years of experience in complete denture fabrication did all the clinical procedures in order to avoid interobserver discrepancies. Complete denture was fabricated using selective pressure final impression technique (zinc oxide eugenol) and bilateral balanced occlusion using a semi-adjustable Hanau Wide Vue 183-2 Articulator (Whip Mix Corporation, Fort Collins, USA). Heat-cured acrylic resin (Trevalon, Dentsply India Pvt. Ltd., Bangalore, India) with compression molding technique was used for denture fabrication.

Methods

Assessment of masticatory performance

The masticatory performance was assessed by fractional sieve test using peanut (3 g) as the test food which was developed by Manly and Braley[10] and modified by Kapur and Soman.[11] Participants were instructed to masticate peanuts (20 chewing strokes) and then spit out particles into beaker. They were also asked to rinse their mouth with water and again spit it in the same beaker.[10,12] Peanut particles were stirred gently using a glass rod so that the stuck particles of peanut can get separated. This was then poured and passed through a US standard mesh sieve of 1700 micrometer opening (number 10, standard test sieve, Dual Manufacturing Company, Ludhiana, India). The residue which was settled in the sieve was collected in a beaker, while the filtrate was collected into test tubes which were then centrifuged at 1500 rpm for 3 min.[13] The volume of both filtrate and residue was recorded and the procedure was repeated at 3 and 6 months of follow-up. Masticatory performance was calculated by F × 100/F + R, where F and R were volume of filtrate and residue respectively.

Assessment of electromyography

Needle EMG signals were recorded with patients sitting in a comfortable office-like chair, arms extended along body and hands placed on thighs. Muscle activity was evaluated by means of EMG recordings of masseter and temporalis muscles on both sides during maximal intercuspation. The surface was cleaned with alcohol and ethyl chloride. Disposable monopolar needle electrodes were inserted into the ventral region of masseter muscle and the anterior portion of temporalis muscle to record signals.[14] EMG signals were made up of superimposed motor unit action potentials.

Assessment of nutritional status

It was recorded by biochemical investigations of the participant’s blood serum.

Hemoglobin

It was done to check nutritional deficiency (of iron, Vitamin B12, and folate) in blood with colorimeter by cyanomethemoglobin method using hemoglobin kit (Bio Lab Diagnostics (I) Pvt. Ltd., Boisar, Maharashtra, India).

Serum calcium

This test measured level of calcium in blood. It is used to assess and manage disorders affecting calcium metabolism. It was measured by Arsenazo method using calcium (Arsenazo) kit (Beckman Coulter, Inc., CA, USA).

Serum albumin

This test measured amount of albumin in blood. It was measured by using bromocresol green by ALB colorimetric assay kit (Elabscience, Houston, Texas, USA).

Vitamin D

Serum 25(OH) D concentrations were estimated by radioimmunoassay (DiaSorin Inc., Stillwater, MN 55082-0285, USA; kit, normal range 9.3–37.9 ng/mL). The sensitivity of this assay was 1.5 ng/mL, the within-run coefficient of variation (CV) was 10.5%, and the total imprecision CV was 8.2% at 22.7 ng/mL.

Evaluation of bone mineral density

Total body BMD was assessed using Lunar Prodigy Advance DEXA system (analysis version: 12.30) (GE Healthcare, Madison, WI, USA).

This randomized controlled trial was ended after achieving the goal of sample size and length of follow-up.

Statistical analysis

Since assumptions of repeated measures analysis of variance (ANOVA) were not met, therefore Friedman’s ANOVA test was used as a nonparametric equivalent to repeated measures ANOVA, to test several related samples assuming that the underlying variable has continuous distribution. The Mann–Whitney U-test was used as a nonparametric equivalent to the t-test for two independent samples. P <0.05 was considered significant. Wilcoxon signed-rank test with Bonferroni correction was used as a nonparametric post hoc test for the domains whose result was found to be statistically significant. P <0.0167 was considered significant for this test. Since the assumptions of independent sample t-test were not met, comparison between patients provided with food supplementation and those who were not given any food supplementation was done using Mann–Whitney U-test, which is nonparametric equivalent of independent sample t-test.

RESULTS

The baseline characteristic is presented in Table 1. One hundred twenty-nine participants were randomized into with and without food supplements. Follow-up was done at 3 months and 6 months. At 3 months of follow-up, 15 participants were lost, and at 6 months of follow-up, 8 participants were lost due to reasons mentioned in CONSORT flow diagram [Figure 1]. A statistically significant change was observed during follow-up for the group with food supplement for BMD, EMG, and masticatory performance (P < 0.01). While, in another group, no change was observed for BMD, but a statistically significant change was observed for EMG and masticatory performance [Table 2]. When both groups (with and without food supplement) and control groups (P < 0.01) were compared together, no statistically significant change was observed [Table 3] except for BMD (P < 0.01) at all time intervals. When nutritional outcomes were assessed with the period of time, no statistically significant change was observed for both groups (with and without food supplement), except for calcium in group which received food supplement [Table 4]. While no statistically significant change was observed for albumin, hemoglobin, Vitamin D, and calcium when both groups (with and without food supplement) and control groups were compared together [Table 5].

Table 1.

Baseline sociodemographic characteristics of control and intervention groups

	With food supplement (n=67)	Without food supplement (n=62)	Control group (n=52)
Age (years)	50.5±8.85	51.3±7.9	49.6±7.95
Education
High school and below	43	39	32
Above high school	16	12	14
Graduation and above	8	11	6
Marital status
Married	58	57	49
Unmarried	1	0	0
Widow	8	5	3
Duration of edentulism (months)	3.2±1.75	2.9±1.95	NA
BMI	21.3±3.1	22.1±2.9	20.5±1.4

BMI: Body mass index, NA: Not available

Figure 1.

Consolidated Standards of Reporting Trials (CONSORT) flow diagram

Table 2.

Comparing changes in outcomes at follow-up from baseline

	Median Z-score (IQR)			P
	Baseline	First follow-up	Second follow-up
With food supplement
BMD	−2.30 (1.90)	−2.10 (1.92)	−2.10 (1.80)	<0.01
EMG temporalis (right)	−0.19 (1.19)	−0.11 (1.23)	0.02 (2.20)	<0.01
EMG Temporalis (left)	0.48 (0.27)	0.50 (0.16)	0.72 (2.01)	<0.01
EMG Masseter (right)	−0.24 (0.61)	0.03 (0.29)	0.04 (1.30)	0.07
EMG Masseter (left)	−0.30 (1.30)	0.08 (0.56)	0.21 (1.75)	<0.01
Masticatory performance	0.10 (0.97)	0.08 (1.01)	0.02 (1.12)	0.04
Without food supplement
BMD	−2.10 (3.30)	−1.90 (2.95)	−2.10 (3.3)	0.16
EMG Temporalis (right)	−0.06 (1.46)	−0.0682 (0.79)	0.2828 (0.48)	0.03
EMG Temporalis (left)	0.49 (0.27)	0.4554 (0.16)	0.4920 (2.09)	<0.01
EMG Masseter (right)	−0.34 (2.12)	0.068 (1.28)	0.059 (1.32)	<0.01
EMG Masseter (left)	−0.07 (1.37)	0.15 (2.35)	0.17 (2.36)	<0.01
Masticatory performance	−0.002 (1.76)	0.104 (1.18)	−0.264 (1.29)	<0.01

IQR: Interquartile range, BMD: Bone mineral density, EMG: Electromyography

Table 3.

Comparing outcomes among three groups at baseline and follow-up

Outcomes	Median Z-Score (IQR)
	Baseline	First follow-up	Second follow-up
EMG Temporalis (right)
Control	-0.11 (1.59)	-0.11 (1.59)	-0.11 (1.59)
With supplement	-0.19 (1.19)	-0.11 (1.23)	0.02 (2.20)
Without supplement	-0.06 (1.46)	-0.07 (0.79)	0.28 (0.48)
P	0.09	0.15	0.68
EMG Temporalis (left)
Control	0.23 (0.90)	0.23 (0.90)	0.23 (0.90)
With supplement	0.48 (0.27)	0.50 (0.16)	0.72 (2.01)
Without supplement	0.49 (0.27)	0.46 (0.16)	0.49 (2.09)
P	0.06	0.14	0.21
EMG Masseter (right)
Control	0.09 (1.81)	0.09 (1.81)	0.09 (1.81)
With supplement	-0.24 (0.61)	0.03 (0.29)	0.04 (1.30)
Without supplement	-0.34 (2.12)	0.07 (1.28)	0.06 (1.32)
P	0.31	0.50	0.85
EMG Masseter (left)
Control	-0.21 (0.91)	-0.21 (0.91)	-0.21 (0.91)
With supplement	-0.30 (1.30)	0.08 (0.56)	0.21 (1.75)
Without supplement	-0.07 (1.37)	0.15 (2.35)	0.17 (2.36)
P	0.94	0.63	0.54
Masticatory performance
Control	0.05 (1.51)	0.05 (1.51)	0.05 (1.51)
With supplement	0.10 (0.97)	0.08 (1.01)	0.02 (1.12)
Without supplement	-0.002 (1.76)	0.10 (1.18)	-0.26 (1.29)
P	0.74	0.99	0.95
Bone mineral density
Control	-0.60 (1.53)	-0.60 (1.53)	-0.60 (1.53)
With supplement	-2.30 (1.90)	-2.10 (1.92)	-2.10 (1.80)
Without supplement	-2.10 (3.30)	-1.90 (2.95)	-2.10 (3.30)
P	<0.01	<0.01	<0.01

Table 4.

Comparison of nutritional outcome in with and without food supplement groups at follow-up

Nutritional outcomes	Median Z-score (IQR)			P
	Baseline	First follow-up	Second follow-up
With supplement
Albumin	0.00 (1.25)	0.00 (0.80)	0.00 (1.00)	0.24
Hemoglobin	0.38 (1.38)	0.41 (1.22)	0.00 (1.27)	0.69
Vitamin D	-0.17 (0.81)	-0.22 (0.57)	-0.21 (0.55)	0.30
Calcium	-0.17 (1.17)	0.00 (1.13)	0.09 (1.18)	0.01
Without supplement
Albumin	0.00 (1.08)	-0.20 (1.60)	-0.33 (1.50)	0.06
Hemoglobin	-0.36 (1.45)	-0.18 (1.05)	-0.27 (1.05)	0.22
Vitamin D	-0.19 (1.09)	-0.23 (1.04)	-0.23 (0.72)	0.16
Calcium	0.14 (1.43)	0.25 (1.38)	0.00 (1.50)	0.88

Table 5.

Comparison of nutritional outcomes among with and without food supplement groups with control group at follow-up

Biochemicals	Median Z-score (IQR)
	Baseline	First follow-up	Second follow-up
Albumin
Control	-0.018 (1.64)	-0.018 (1.64)	-0.018 (1.64)
With supplement	0.00 (1.25)	-0.00 (0.80)	0.00 (1.00)
Without supplement	0.00 (1.08)	-0.20 (1.60)	-0.33 (1.50)
P	0.931	0.754	0.893
Hemoglobin
Control	0.04 (1.92)	0.04 (1.92)	0.04 (1.92)
With supplement	0.38 (1.38)	0.41 (1.22)	0.00 (1.27)
Without supplement	-0.36 (1.45)	-0.18 (1.05)	-0.27 (1.05)
P	0.941	0.904	0.837
Vitamin D
Control	-0.42 (1.15)	-0.42 (1.15)	-0.42 (1.15)
With supplement	-0.17 (0.81)	-0.22 (0.57)	-0.21 (0.55)
Without supplement	-0.19 (1.09)	-0.23 (1.04)	-0.23 (0.72)
P	0.930	0.776	0.746
Calcium
Control	-0.23 (1.59)	-0.23 (1.59)	-0.23 (1.59)
With supplement	-0.17 (1.17)	0.00 (1.13)	0.09 (1.18)
Without supplement	0.14 (1.43)	0.25 (1.38)	0.00 (1.50)
P	0.811	0.857	0.777

DISCUSSION

In this study, effect of food supplement was assessed among completely edentulous women rehabilitated with complete denture. It was hypothesized that after providing food supplement and rehabilitating with complete denture, overall health of edentulous women might improve. However, we have not observed any significant difference in the mentioned outcomes. At baseline, sociodemographic characteristics were similar in intervention and control groups. It showed minimization of confounding variables such as age, duration of edentulism, and body mass index (BMI). This minimization of confounding variables is supported by predefined clear inclusion and exclusion criteria.

Electromyographic recordings of both sides of masseter and temporalis were done at baseline and follow-up in this study. It has been observed[15] that with an increasing age, there is a decrease in thickness of masseter and temporalis muscles and also reduction in muscle strength. Although previous studies have shown that after dental rehabilitation, there was an increase in masseter muscle thickness,[16,17] but in this study, no statistically significant difference was observed for EMG when both groups (with and without food supplement) and control group were compared together. In one study,[17] 3-month follow-up showed a statistically significant difference in masseter muscle thickness after rehabilitation with complete denture, but it was conducted on male patients with sample size of 12, and study design was controlled before and after. Maybe if more time (more than 12 months) is given for a follow-up, different results would be observed. A statistically significant difference was observed when groups (with and without food supplement) were compared individually. This study corresponds to a study by Carletti et al.[18] which stated that remarkable improvement was observed in muscles of mastication (temporalis, masseter, and medial and lateral pterygoid) among patients with edentulism after wearing new prosthesis. Similar results were also observed by Müller et al.[19] who advocated the use of denture on both arches, and observed a gain in masseter muscle thickness after 6 months. When Zuccolotto et al.[20] compared EMG activity of temporalis and masseter muscles after using sliding plates among edentulous patients, a significant increase was observed, which corresponds to the result of this study. Piancino et al.[21] reported EMG activity among edentulous participants and observed that anterior temporalis was larger with old denture than in other conditions. In a systematic review,[22] it was also reported that muscular (temporalis and masseter) activity improved among edentulous subjects after implant treatment. It becomes difficult to compare and generalize the result of this study as there are few studies which have observed EMG activity of temporalis muscle on edentulous women.[22]

Masticatory performance did not show a significant improvement with time in food supplement group than without food supplement group. This could be due to the fact that participants who were taking food supplement may have relied on food supplement rather than on routine food items. Moreover, routine food items trigger activity of masticatory muscles perhaps thereby an improvement in mastication was observed in group which did not receive food supplement.

Due to decrease in bite force and masticatory performance, there is a negative impact of ageing on masticatory activity. These hinder food chewing and may result in impaired digestive process, nutritional status, and overall health. Few studies[18,23] have shown remarkable improvement in mastication after the use of denture, which could be due to increased occlusal support after dental prosthesis,[18] which is also evident in this study. Although, when masticatory performance was evaluated between the groups, no change was observed. This could be perhaps due to the fact that food supplement had no role in mastication. Because participants of both groups were denture wearers, hence masticatory performance was not affected by food supplement.

In the present study, nutritional outcome was measured by levels of hemoglobin, Vitamin D, calcium, and serum albumin. Out of several markers for assessment of malnutrition, albumin, a serum hepatic protein and one of the most abundant proteins found in blood, is widely used by the clinicians, which is also considered a better predictor of malnutrition as compared to subjective global assessment and BMI.[24]

As mentioned earlier that after tooth loss, older adults avoid hard food items and go for softer food, which generally lack protein, micronutrients, and fiber. In this study, it was observed (after asking the diet consumed before and after wearing denture from participants) that higher protein consumption was missing. Moreover, majority of participants were consuming plant-based protein rather than animal protein, which are less digestible and contain less proportion of amino acids required for growth of the body.[25] This could be the reason of low albumin levels. However, in a recent study, this theory was discarded.[26] Rather authors suggested that no matter what protein source is, it does not affect muscle mass and strength of an individual.[26] In the present study, albumin level was not significantly different within groups, which may be due to no remarkable difference in protein intake before and after complete denture.

Furthermore, it was also observed that participants who received food supplement were relying more on food supplement rather than on routine food items. In a study,[27] it was observed that dietary protein is considered a crucial factor in assessing serum albumin. The authors further observed that nutritional supplement could only be favorable in participants who have low albumin levels (less than a normal range of 3.4–5.4 g/dL).[27] This study showed a similar finding that there was no difference in albumin levels after providing food supplement.

Vitamin D levels were found to increase in both groups. However, a significant rise was observed in group with food supplement, since they were consuming Vitamin D as supplement. An average time taken in a healthy individual to raise the level after taking supplement for Vitamin D is 2–3 months,[28] and this could be a reason for low level of Vitamin D at baseline. In the group without food supplement, it may take longer time as no dietary instructions were given nor change in lifestyle or Vitamin D-rich diet was advocated.

Calcium levels were also observed to be different in both groups. The group which did not receive any food supplement showed a statistically significant difference. This could be due to participants relying more upon food supplement and not consuming calcium-rich diet.

It was observed that the group which received food supplement showed a statistically significant difference in BMD. It was found that Vitamin D supplementation reduces tooth loss in the elderly and increases BMD.[29] A statistically significant difference was also observed between groups. It was observed that either Vitamin D with calcium or calcium alone is considered a basic treatment in managing osteoporosis, bone loss, or fractures.[30,31] Hence, BMD was found to increase which is relatable to our study. In a meta-analysis, an association between Vitamin D, calcium, and BMD was also found.[32] The authors have observed changes in BMD after rehabilitation with complete denture, but studies on with food supplement were not found so far.[33]

In this study, not much change in nutrient levels was observed in both groups as dietary counseling was not provided to patients either before or after recruitment. Moreover, changing dietary habits with types of food consumed may be a multifactorial adaptation process that takes much longer than a year for a measurable effect.[34] In addition, dietary counseling can improve fruit and vegetable intake in an edentulous individual.[35] Thus, a randomized controlled trial in which patients are followed for a longer period of time and in which they are given specific individual dietary counseling might maximize the possibility of dietary improvement.[2] In this study, patients were recruited who visited a hospital for complete denture fabrication. Hence, generalizations of the study finding need to take this point into consideration. This study adds evidence in scientific literature that food supplement may not be the best choice to give each completely edentulous patient after rehabilitation with complete denture. Regular use of complete denture itself may be sufficient enough to improve nutritional status.

CONCLUSION

It was observed that majority of outcomes were not changed significantly for food supplement group than without food supplement group in completely edentulous women rehabilitated with complete denture.

Financial support and sponsorship

The authors would like to acknowledge the Rapid Grant Young Investigator Scheme of DBT, New Delhi, India, for providing research grant. The authors would also like to acknowledge DST, India, under Cognitive Science Research Initiative and SEED and State Science and Technology Programme (SSTP) schemes for providing the salary support to the research fellows Kapila Kumar and Mani Khandpur.

Conflicts of interest

There are no conflicts of interest.