ABSTRACT
Background:
Chronic periodontitis is a prevalent inflammatory disease that necessitates effective treatment strategies. This study aimed to compare the efficacy of curcumin-loaded nanofibers with metronidazole gel in treating chronic periodontitis.
Methods:
A double-blind, randomized controlled trial was conducted involving patients diagnosed with chronic periodontitis. Participants were randomly assigned to receive either curcumin-loaded nanofibers or metronidazole gel as an adjunct to scaling and root planning. Clinical parameters were assessed at baseline, one month, and three months post-treatment.
Results:
Both treatment groups exhibited significant improvements in probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) at all follow-up intervals compared to baseline. Notably, the curcumin-loaded nanofiber group demonstrated statistically significant greater reductions in PD and CAL at three months compared to the metronidazole gel group (P < 0.05).
Conclusion:
Curcumin-loaded metronidazole was used in nanofibers technology on chronic periodontitis patients, showing the possibility of improving therapeutic results, especially in posteriori periods, compared to the conventional metronidazole gel.
KEYWORDS: Chronic periodontitis, curcumin, double-blind, metronidazole gel, nanofibers, randomized controlled trial
INTRODUCTION
Chronic periodontitis is a prevalent inflammatory disease characterized by the progressive destruction of the tooth-supporting structures.[1,2,3] Current treatment focuses on mechanical debridement via scaling and root planning, often supplemented with adjunctive therapies like metronidazole gel. However, limitations exist with these approaches, including antibiotic resistance and side effects.[4,5,6,7]
Curcumin, a natural polyphenol with anti-inflammatory and antioxidant properties, has shown promise in periodontal therapy.[8] However, its clinical application is limited by poor bioavailability. Nanofiber-based drug delivery systems offer a solution by providing controlled release and enhanced bioavailability.
This study aimed to compare the clinical efficacy of curcumin-loaded nanofibers with metronidazole gel as an adjunct to SRP in treating chronic periodontitis. We hypothesized that curcumin-loaded nanofibers would be superior to metronidazole gel in improving clinical parameters.
MATERIALS AND METHODS
Study design and participants
This double-blind, randomized controlled trial was conducted at the Department of Periodontics, People’s Dental Academy, Bhopal, India, from January 2022 to January 2025. Ethical approval was obtained from the Institutional Ethics Committee. Patients diagnosed with chronic periodontitis were recruited from the outpatient Department of Periodontics. Inclusion criteria were as follows: age of ≥ 30 years, presence of ≥ 4 teeth with probing depth (PD) of ≥ 5 mm, and radiographic evidence of bone loss. Exclusion criteria included systemic diseases (e.g., diabetes, cardiovascular disease, immunosuppression), pregnancy or lactation, smoking, and antibiotic use within the past three months. Informed consent was collected and signed from each participant prior to inclusion to the study.
Randomization and blinding
Suitable participants were randomly assigned to either the curcumin-loaded nanofiber group (Group A) or the metronidazole gel group (Group B) using a computer-generated randomization sequence with a 1:1 allocation ratio. The randomization sequence was concealed in sequentially numbered, opaque envelopes. Both patients and examiners were blinded to the treatment allocation. The nanofibers and gel were prepared by a third party and packaged in identical containers to maintain blinding.
Treatment protocol
All participants received full-mouth SRP using ultrasonic and hand instruments. Following SRP, Group A received subgingival application of curcumin-loaded nanofibers (10% w/w curcumin), while Group B received subgingival application of metronidazole gel (1% w/w). The nanofibers and gel were applied using a blunt-tipped cannula to ensure delivery into the periodontal pockets. Treatments were administered once a week for four consecutive weeks. Participants were instructed to avoid brushing and interdental cleaning in the treated areas for 12 h after each application.
Outcome measures
Clinical parameters were assessed at baseline, 1 month, and 3 months post-treatment by a blinded examiner. The following parameters were recorded:
Probing Depth (PD): Measured to the nearest millimeter using a periodontal probe at six sites per tooth.
Clinical Attachment Level (CAL): Measured to the nearest millimeter from the cementoenamel junction to the base of the periodontal pocket.
Bleeding on Probing (BOP): Assessed as present or absent at six sites per tooth.
Statistical analysis
The information was processed through the SPSS software version 26 (IBM). The participant’s fundamental traits were summarized using descriptive statistics. The comparison of the baseline characteristics among the groups was performed with one-way analysis of variance (ANOVA). Paired t-tests were used to compare clinical parameters within each group from baseline to 1 and 3 months. Independent t-tests were used to compare changes in clinical parameters between the groups at 1 and 3 months. P values < 0.05 were considered statistically significant.
RESULTS
Baseline characteristics
A total of 60 patients (30 in each group) was completed the study. Table 1 presents the baseline demographic and clinical characteristics of the participants. No significant differences were observed between the groups at baseline (P > 0.05).
Table 1.
Baseline characteristics of participants
| Characteristic | Group A (Curcumin nanofibers) | Group B (Metronidazole gel) | P |
|---|---|---|---|
| Number of participants | 30 | 30 | – |
| Age (years) | 42.5±8.2 | 44.3±9.1 | 0.385 |
| Gender (Male/Female) | 17/13 | 15/15 | 0.712 |
| Mean PD (mm) | 5.8±1.2 | 5.6±1.1 | 0.421 |
| Mean CAL (mm) | 6.2±1.5 | 6.0±1.3 | 0.587 |
| BOP (%) | 75.3±12.5 | 72.8±11.8 | 0.493 |
PD: Probing depth, CAL: Clinical attachment level, BOP: Bleeding on probing
Clinical outcomes
Both groups showed statistically significant improvements in PD, CAL, and BOP at 1 and 3 months compared to baseline (P < 0.05). Table 2 displays the mean changes in clinical parameters from baseline to 3 months. Table 3 displays intergroup comparisons at three months interval.
Table 2.
Changes in clinical parameters from baseline to 3 months
| Parameter | Group A (Curcumin nanofibers) | Group B (Metronidazole gel) |
|---|---|---|
| Change in PD (mm) | −2.8±0.8 | −2.2±0.7 |
| Change in CAL (mm) | −2.5±0.9 | −1.8±0.8 |
| Change in BOP (%) | −52.1±10.2 | −48.5±9.5 |
PD: Probing depth, CAL: Clinical attachment level, BOP: Bleeding on probing
Table 3.
Intergroup comparisons at 3 months
| Parameter | Group A (Curcumin nanofibers) | Group B (Metronidazole gel) | P |
|---|---|---|---|
| PD (mm) | 3.0±0.9 | 3.4±1.0 | 0.032 |
| CAL (mm) | 3.7±1.1 | 4.2±1.2 | 0.048 |
| BOP (%) | 23.2±8.8 | 24.3±9.1 | 0.521 |
PD: Probing depth, CAL: Clinical attachment level, BOP: Bleeding on probing
DISCUSSION
This double-blind, randomized controlled trial investigated the clinical efficacy of curcumin-loaded nanofibers compared to metronidazole gel as an adjunct to SRP in treating chronic periodontitis. Our findings demonstrate that both treatment modalities led to significant improvements in clinical parameters, including PD, CAL, and BOP, at 1 and 3 months post-treatment. However, the curcumin-loaded nanofiber group exhibited statistically significant greater reductions in PD and CAL at 3 months compared to the metronidazole gel group. This suggests that curcumin-loaded nanofibers may offer a more effective treatment option for chronic periodontitis, particularly in achieving long-term periodontal stability. The enhanced efficacy of curcumin nanofibers could be attributed to their sustained release properties, which ensure prolonged drug delivery and better tissue penetration, thereby maximizing the therapeutic effects of curcumin.
Our results agree with previously conducted research that suggested the positive impact of curcumin use in periodontal therapy.[8,9] Our study is novel in terms of using a nanofiber-based delivery system for curcumin, which may explain the improved results that were registered. Although this seems to add value to curcumin nanofibers, there are many limitations to take into consideration. Most importantly is the small sample size and short duration of follow-up which was only 3 months. There is a need for more comprehensive studies to validate the effects of curcumin nanofibers with a large sample size and prolonged duration. Also, we did not assess the effects of curcumin nanofibers on the subgingival microbiota. There is a gap in the knowledge regarding the antimicrobial activity of curcumin-containing nanofibers and their impact on the composition of the periodontal microbiome, which should be addressed in further studies.
CONCLUSION
This proof-of-concept double-blind, randomized controlled trial affirms that curcumin-loaded nanofibers stand out as an effective substitute to metronidazole gel in treating chronic periodontitis. The curcumin nanofiber group exhibited statistically significant greater reductions in PD and CAL at 3 months compared to the metronidazole gel group. These findings suggest that curcumin nanofibers may offer enhanced therapeutic efficacy and contribute to improved long-term periodontal health.
Ethical clearance
The ethical clearance was taken from Institutional Ethical Committee of People’s Dental Academy, Bhopal.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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