Healing of extraction socket with or without Gelatamp^® after impacted mandibular third molar surgery: A prospective, comparative, randomized, split mouth study

Abstract

Introduction:

This study was designed to evaluate and compare the efficacy of Gelatamp^® as a topical hemostatic and bactericidal agent in reduction of postoperative complications and soft tissue healing with routine closure after surgical extraction of impacted mandibular third molar.

Material and Methods:

This was a split-mouth, prospective, double-blinded, randomized control study. The study was carried out on 30 patients (60 impactions) aged between 18 and 45 years with Bilateral Impacted mandibular 3^rd molar teeth (class II; Mesioangular; position B) indicated for surgical extraction. SITE I (n = 30) obtained Gelatamp following extraction, and the SITE II (n = 30) received no intervention. The key objectives were to evaluate bleeding after 40 minutes of pressure pack removal, soft tissue healing, postoperative sequelae such as pain, swelling, incidence of wound dehiscence, and alveolar osteitis maximal interincisal opening on 1, 3, 7, and 14 postoperative days.

Result:

The findings demonstrated a statistically significant difference among extraction sites for hemorrhage scores after 40 minutes of pressure dressing removal in SITE I (p = 0.039). No statistically significant difference present between the sites for pain, edema, soft tissue healing, wound dehiscence, and maximal interincisal opening recorded on all the follow-up days. In addition, no significant difference was detected for incidence of alveolar osteitis on 3 and 7 days after surgery (p > 0.05).

Conclusion:

The results of our data suggested that Gelatamp^® could potentially be used to prevent postoperative sequalae such as hemorrhage and permits improved soft tissue healing after surgical extraction of impacted mandibular 3^rd molar.

INTRODUCTION

An impacted tooth is defined as any tooth that is completely or partially unerupted and is positioned against another tooth, bone, or soft tissue so that its further eruption in the oral cavity is unlikely, described according to its anatomic position.[1] Mandibular 3^rd molars are the last tooth to erupt in the oral cavity, appearing between the ages of 17 and 25 years.[2] Because of its anatomical position, low accessibility, and possible damage to surrounding vital structures such as nerves, arteries, soft tissues, and adjacent tooth, the surgical removal of an impacted third molar is difficult. The transalveolar approach is used to remove an impacted third molar, which is associated with postoperative sequalae such as reduced mouth opening, swelling, pain, bleeding, and, in rare cases, intrabony defects distal to the mandibular second molar.[3]

Numerous local or systemic factors may be the cause of bleeding, which necessitates the administration of local hemostatic measures. These hemostatic agents should meet certain ideal requirements: these should be bacteriostatic, easy to handle, sterile, suitable for single use, remain in place after application, and disintegrate within a few weeks of augmentation. Gelatamp^® is a resorbable sponge of gelatin marketed as a sterile dressing which can retain 55–75 times its weight in blood and is associated with generation of a mechanical grid that promotes clot formation. It is hypothesized to function essentially by promoting platelet breakdown, resulting in the release of thromboplastin, which stimulates thrombin generation in the sponge’s interstices. Gelatamp^® incorporates finely distributed colloidal silver particles, producing a broad active surface for the continuous discharge of silver ions. Topical use of silver nanoparticles to wounds enhances and speeds the healing process. It also functions as an antibacterial agent that regulates cytokines involved in tissue healing.[4]

The purpose of this study was to investigate and compare the performance of Gelatamp^® as a topical hemostatic and bactericidal agent in reducing postoperative complications and improve soft tissue healing with routine closure following extraction of impacted mandibular 3^rd molar.

MATERIAL AND METHODS

A prospective, comparative, double-blind split mouth study was carried out on 30 patients (power of study was found to be 90%) with Bilateral Mandibular Impacted 3^rd molars attending the Out-patient Department (OPD) of Oral and Maxillofacial Surgery of our institution, following approval from Institutional Ethical Committee (IEC).

Inclusion criteria

1. American Society of Anaesthesiologists (ASA) Groups I and II patients.

2. Patient aged between 18 and45 years.

3. Bilateral, Mesioangular, Class II, Position B impacted Mandibular 3^rd molar.

Exclusion criteria

1. Medically compromised patients.

2. Patients not willing for surgery.

3. Patient with habit of smoking and consuming alcohol.

4. Pregnant and lactating females.

5. Impacted tooth with associated bony pathology.

Patients were randomly categorized using lottery technique into two sites. Site I (n = 30) received Gelatamp^® after surgical extraction, and Site II (n = 30) received no intervention. A signed informed consent was acquired from each patient after explaining possible outcomes and sequalae. A detailed case history of the selected patients was recorded, and all necessary radiographic and hematological investigations including orthopantomogram (OPG) and viral markers were done.

Surgical procedure

Patients were seated on a dental chair; extraoral and intraoral part preparation was done using 5% povidone iodine. Operating site was anesthetized using 2% lignocaine and 1:80,000 adrenaline. The extraction of mandibular third molar was done following a standardized surgical technique. Briefly, Ward’s incision was made, a full-thickness mucoperiosteal flap was elevated, osteotomy and tooth sectioning were performed under copious amount of 0.9% saline irrigation, and tooth was elevated [Figure 1]. After tooth removal, the socket was augmented with Gelatamp^® in SITE I and the mucoperiosteal flap was placed and primary closure with 3-0 silk was done [Figures 2 and 3]. After 4 weeks, the control site (SITE II) tooth was surgically extracted and its socket was primarily closed with 3-0 silk sutures without Gelatamp^® augmentation. Pressure pack using gauze pad given in both cases postoperatively. The patients were advised to keep the pressure dressing for the next 40 minutes of surgery and to avoid hot food and beverages and rinsing/spitting for next 24 hours. Strict soft diet with maintenance of oral hygiene using 0.2% chlorhexidine gluconate mouthwash for 2 times per day and warm saline rinses for 5–6 times per day after 24 hours of surgery was advised. Postoperative antibiotics and analgesics for next 5 days were prescribed. Suture removal was done after 7 days of surgery.

Figure 1.

Extraction Socket

Figure 2.

Gelatamp^®

Figure 3.

Placement of Gelatamp^® in Extraction Socket

The key objectives were bleeding assessment after 40 minutes of pressure pack removal (According to Maani et al. index, 2009).[5] Patients were also recalled on 1, 3, 7, and 14 postoperative days for evaluation of pain (According to 10 cm Visual Analogue Scale or VAS),[6] swelling assessment (in mm; According to Gabka and Matsumura),[7] infection present as pus discharge and dehiscence at operated site, soft tissue healing (According to Landry et al. index, 1988),[8] maximum interincisal opening in mm, and dry socket at 3 and 7 postoperative days.

Statistical methods

Data were analyzed using SPSS software version 25.0 for analysis. All the raw data were summarized as mean and standard deviation. To determine the difference in frequency of event in different groups, the chi Square test was used and for testing the equality of two mean one-way ANOVA test was used. The level of statistical significance was set at 0.05 (P value < 0.05).

RESULTS

A total of 30 patients (17 men and 13 women) with a mean age of 28.9 ± 6.98 years were included in this split mouth study, and the entire study population was divided into two equal sites. A total of 60 impactions were done in 30 patients on each side.

The pain scores were evaluated for both sites at regular intervals. For the postoperative day 1, it was 4.13 ± 0.77 at Site I and Site II had 4.30 ± 0.65 (P = 0.37), which gradually decreased greatly by day 14 and no statistically significant difference found between the sites in any of the follow-ups [Graph 1].

Graph 1.

Postoperative pain {Acc. to 10cm Visual Analog Scale (VAS)}[6]

Table 1 shows the postoperative swelling which was present at both the sites. Swelling measurements between lateral canthus of eye to angle of mandible, tragus of ear to corner of mouth and tragus of ear to pogonion at postoperative day 1 showed maximum swelling, which gradually decreased by postoperative day 14 with no statistically significant difference between both the sites at any of the follow-up periods.

Table 1.

Postoperative swelling in millimeters (according to Gabka and Matsumura)[7]

Measurement Point	Swelling Assessment on	SITE I		SITE II		P
		Mean	SD	Mean	SD
From Lateral canthus of eye to angle of mandible	Preop 1st Day 3rd Day 7th Day 14th Day	82.15 85.85 84.95 83.94 82.49	0.67 0.67 0.67 0.66 0.68	82.35 85.90 84.97 83.71 82.82	0.60 0.26 0.23 0.27 0.61	0.231 0.054 0.065 0.079 0.051
From tragus of ear to corner of mouth	Preop 1st Day 3rd Day 7th Day 14th Day	114.03 117.03 116.09 115.28 114.28	0.29 0.20 0.14 0.15 0.18	114.08 117.05 116.09 115.28 114.28	0.27 0.19 0.14 0.19 0.18	0.530 0.817 1.000 0.942 1.000
From tragus of ear to pogonion	Pre-op 1st Day 3rd Day 7th Day 14th Day	138.76 142.43 141.86 140.76 139.49	2.90 2.79 2.83 2.81 3.00	138.13 141.87 141.03 139.97 138.47	2.97 2.92 2.91 2.88 2.93	0.415 0.454 0.266 0.287 0.189

The mean preoperative maximum interincisal opening for Site I was 35.93 ± 1.28 and in Site II was 36.1 ± 1.28 (P = 0.60). The postoperative MIO at 1^st postoperative day was 29.97 ± 1.29 and 29.90 ± 1.34 in Site I and Site II, respectively, which gradually improved by day 14 with 36.63 ± 1.23 mm in Site I and 36.66 ± 1.30 mm in Site II (P = 0.91). No statistically significant differences were seen between both the sites [Graph 2].

Graph 2.

Maximum interincisal opening in millimeters

Soft tissue healing assessment was made by color of gingival, bleeding on palpation, presence of granulation tissue, epithelization of the margins, and presence of suppuration (According to Landry et al., 1988)[8] Soft tissue healing ratings were greater with Gelatamp^®; however, the findings were not statistically significant on all postoperative days (P = 0.72). Healing scores rated excellent in 4 patients in Site I and 3 patients in Site II, whereas healing score rated very good in 26 patients in Site I and 27 patients in Site II at postoperative day 14 [Table 2].

Table 2.

Healing Index scores (Acc. To Landry et al.)[8]

Postoperative day	Soft tissue healing	Site-I		Site II		F Score	P
		Frequency	Percent	Frequency	Percent
1st Day	Good	30	100.0	30	100.0	0.00	1.00
3rd Day	Good	5	16.7	18	60.0	2.98	0.089
	Very Good	25	83.3	12	40.0
7th Day	Good	0	0	2	6.7	2.071	0.155
	Very good	30	100.0	28	93.3
14th Day	Very good	26	90.00	27	86.67	0.127	0.723
	Excellent	4	10.00	3	13.33

When evaluating other postoperative complications, infection and dry socket were absent in both the sites at all the follow-up intervals and no statistically difference was noted.

Bleeding was assessed postoperatively using Maani et al., 2009, bleeding index.[5] The bleeding was assessed at both the sites after 40 minutes of pressure pack removal. Twenty-eight cases in Site I and 16 cases in Site II showed Grade 0 bleeding which implies almost no bleeding. Two cases in Site I and 11 cases in Site II showed Grade I bleeding score which implies slight ooze of blood. Three cases in Site II showed Grade bleeding which implies clinically significant bleeding. A statistically significant difference was noted between the sites for bleeding scores [Graph 3].

Graph 3.

Bleeding Score (Acc. to Maani et al. Bleeding assessment scale)[5]

DISCUSSION

The extraction of an impacted mandibular third molar is a complex procedure owing to its anatomical position, restricted accessibility, and probable risk of injury to surrounding vital structures.[3] The removal of mandibular impacted third molar by the trans alveolar technique is associated with several postoperative sequelae, including edema, discomfort, trismus, and hemorrhage.[9,10]

Bleeding during mandibular third molar surgery may occur due to several local or systemic factors. Predisposing factors include failure to follow surgical guidelines, such as continuous and forceful spitting. Pre-existing infections, such as pericoronitis and periapical granulomas, or any bleeding disorder that may generate significant bleeding, require administration of extra hemostatic drugs. Local hemostatic agents are used to reduce surface bleeding and capillary leakage. A good agent should provide rapid hemostasis, be biocompatible, and should promote healing.[11]

Gelatamp^® (gelatine sponge with colloidal silver), commercially available as “Roeko Gelatamp” manufactured by Coltene, is an absorbable gelatin sponge that solidifies into a scaffold which can hold several times its weight in blood and facilitates in production of clot. It is composed of 95% gelatine and 5% finely distributed colloidal silver ions, which are released when exposed to water. It acts by the generation of a mechanical grid that assists in clotting whereas, the silver ions at low concentrations provide antibacterial effects that are also efficient against antibiotic-resistant bacteria. Silver is not rinsed out of the gelatin sponge but is rather released continuously as the sponge resorbs, and it requires a substrate for continuous release for which gelatin acts as a transporting agent. It remains confined within the alveolus for 4 weeks before being completely reabsorbed.[4]

The pain score readings showed a similar pattern in both the sites, and there was an increase in pain scores on postoperative day 1, which gradually decreased by the day 14 with no statistically significant difference being evident in subsequent follow-ups. Since both extraction sites were free of infection preoperatively, the reduction in pain on Site I supports the hypothesis that Gelatamp^® has a moderate analgesic effect when given topically. However, still, no significant difference in pain was found between the sites. The results are congruent with those of Yuasa et al.[12] who observed no significant difference in pain scores after the augmentation of a local hemostatic agent into an extraction socket.

Swelling following the surgical removal of a tooth is an inevitable consequence of the procedure. Swelling was measured using the technique proposed by Gabka and Matsumura[7] using a measuring scale and a thread. The onset of swelling is typically between 12 and 24 hours following the procedure, with a peak swelling noted 48–72 hours postoperatively. In the immediate postoperative period, ice packs can be helpful in managing swelling, or else perioperative steroids can be used. In this study, face measurement as an index of postoperative edema showed a general tendency of considerable rise after 24 hours following surgery when assessed from several landmarks. The swelling gradually reduced over the next few days at both extraction sites. This is consistent with previous investigations by Gülnahar and Kupeli[13] and Aksoy et al.[14] that found comparable results and explained the fact that bone osteotomy causes a greater degree of tissue injury and consequently a more inflammatory response.

As a result of surgical trauma and excessive edema, trismus is a common postoperative complication following the removal of an impacted tooth. This causes the muscles to contract, resulting in loss of range of motion. The mouth opening is increased with the help of drugs used to manage pain and swelling, followed by physiotherapy. Kim et al.[15] found that a shortened mouth opening of more than 10 mm is substantially linked with the degree of impaction. In our study, the postoperative mouth opening at both sites decreased on postoperative day 1, but steadily increased on 3, 7, and 14 postoperative days. This is consistent with Ten Bosch, Van Gool, and Greenfield and Moore who revealed that maximum trismus occurs between 24 and 48 hours after surgery. The reduction in mouth opening was similar at both the sites, with no significant difference observed on all follow-up days.[16,17]

Postoperative infections appeared as pus discharge and wound dehiscence. We found no statistically significant difference in the occurrence of postoperative infection in any of the patients, and the wounds healed uneventfully at both the sites, which is similar with the results of Farhadi et al.[18]

Soft tissue healing ratings were greater with Gelatamp^®; however, the findings were not statistically significant on all postoperative days for both sites. This is similar to an earlier study done on Gelatamp^® by Prabhusankar et al.[4] and Maani et al.[5] The initial phase of soft tissue healing begins with vascular constriction and the development of fibrin clots. Proinflammatory cytokines and growth factors are produced by the clot and the surrounding wound tissue. Once the bleeding has been stopped, inflammatory cells move into the wound (chemotaxis) and commence the inflammatory phase. The inclusion of colloidal silver in Gelatamp^®, which produces silver ions when wet, provides antimicrobial effect and is also effective against antibiotic-resistant bacteria.[19]

Dry socket (alveolar osteitis) can be caused due to early breakup of clotted blood in the extraction socket, leaving the bone exposed to the oral environment. In this study, none of the sites showed signs of alveolar osteitis, and this finding was comparable with other studies by Ragab HR, Melek L[20] and Blum IR,[21] Fridrich KL, and Olson RA.[22]

A statistically significant difference was present between the study site (Site I) and the control site (Site II) in terms of postoperative bleeding after 40 minutes of pressure pack removal. Site I augmented with Gelatamp^® showed almost negligible hemorrhage as compared to Site II. This observation is similar with the results of Prabhusankar et al.[4]

In our study, all the procedures were conducted on an outpatient basis using local anesthesia with no problems. Material used in this experiment was found to be biocompatible, with no obvious foreign body response or material rejection. Gelatamp^® offers high soft tissue healing capabilities and hemostatic qualities, making it appropriate for use in regular clinical practice during the extraction of a partially or completely unerupted mandibular third molar, according to our findings.

When we compared the overall results at the two sites, there was a significant reduction in discomfort, trismus, and facial edema, along with a better perception of the patient’s quality of life, following mandibular third molar extraction with Gelatamp^® augmentation in the extraction socket. However, further long-term research is essential to confirm these short-term observations and assess the potential advantages in the overall healing process.

CONCLUSION

The outcome from this study could prove valuable for oral surgeons, dental practitioners, and patients, enabling them to make more informed decisions about the choice of adjunctive materials in impacted mandibular third molar surgeries. In addition, this study highlights the need for continued investigations into innovative techniques and materials that can further enhance the healing process and patient comfort postsurgery. Ultimately, this study contributes to the broader understanding of optimizing postoperative care and outcomes in oral surgery, ultimately improving the patient’s overall quality and standard of life.

Ethical approval

Ethical clearance was obtained from Sardar Patel Postgraduate institute of Dental and Medical Sciences, Lucknow Institutional Ethical Committee with Reference no. OMFS/03/212223/IEC dated 14.03.2022.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.