Comparative evaluation of BlueM gel with hyaluronic acid gel as wound healing agents for topical application following gingivectomy.

The present study will be commenced only after approval is obtained from the institutional ethical committee, KMC - Kasturba Hospital, MAHE, Manipal.IN-VIVO STUDY DESIGN:40 otherwise healthy individuals who require functional crown lengthening procedure as a standard of care will be selected for present study. The sample size was determined using G*power, version 3.0.1(Franz Faul universitat, Kiel, Germany).ALLOCATION RANDOMIZATION AND BLINDING:- Selection of the participants will be based on the exclusion and the inclusion criteria. All the 40 participants will be divided into test and the control groups. The randomized block procedure will be carried out by the co-investigator for allocation of the participants into the test and the control groups. Block randomization will be done in block of 4, with a balanced combination of 6. Accordingly, before the procedure, the participants will be allocated to the randomly chosen blocks, co-investigator will divide the gels according to groups and give it to the principal investigator. participants will be receiving gel formulations in identical tubes/container. Principal Investigator will be blinded to the randomization process. Participants will be explained about benefits and side effects of both the products but will not be informed about which group product will be given to them. CROWN LENGTHENING PROCEDURE IN PARTICIPANT:- Area of surgical site to be anesthetized using 2% lignocaine local anaesthesia.- Sulcus depth on each surface is explored with periodontal probe.- Periodontal knives (Kirkland knives) to be used to give incision on facial and lingual surfaces.- The incision is started apical to the points marking the course of the sulcus and is directed coronally to a point between the base of the sulcus and the crest of the bone.- Excised tissue wall to be removed, cleaned, and closely examined for any tissue tags which is to be curetted.- Osseous reduction to be done to maintain biological width to minimum 1 mm in every participant.- Area of surgical site prepared to receive topical application post-surgery. .PREPARATION OF HA GEL:Gel base was prepared using Carbopol 940 (manufactured by Sigma-Aldrich) by soaking in water overnight. 0.1% w/v concentration of Carbopol gel was prepared with suitable dilution in water.1% and 5% Low MW + High MW HA gel to be prepared by dissolving an appropriate amount of HA in 0.1% w/v of Carbopol gel under sterile laboratory conditions of GO-K Bioincubator facilities. PACKAGING OF MATERIALS:- Packaging of both the materials to be done in identical packaging.APPLICATION OF HA GEL (group A):-20 participants are randomly selected based on inclusion criteria. After the gingivectomy procedure, surgical site to be covered by HA gel formulation which is being prepared.- Pea sized volume of gel to be applied over the surgical area immediately after the procedure.- participants are advised to apply the gel 3 times a day for one week.- participant to be recalled for subsequent follow-ups. APPLICATION OF BLUE M GEL (group B):- 20 participants are randomly selected based on inclusion criteria. After the gingivectomy procedure, surgical site to be covered by Blue M gel which is commercially available.- Pea sized volume of gel to be applied over the surgical area immediately after the procedure.- participants are advised to apply the gel 3 times a day for one week.- Participant to be recalled for subsequent follow-ups. COE pack dressing material which is standard of care and currently practiced treatment in the dept. is not included in the comparison for the following reasons:

1. • They do not possess any anti-bacterial, pain control as well as healing properties. (O’neil, T. C. (1975))(Jorkjend, L., & Skoglund, L. A. (1990).2)-It hardens after application.- 3) plaque accumulation more in area of pack application.- 4)severe tissue reaction and irritation (Nezwek et al., 1980, Grant and Bernick, 1972).
2. Zinc oxide is cytotoxic in nature (Seker et.al., 2018) 6) Bluem gel and PERIO-AID gel, that are to be compared in the study are available in topical gel formulation which absorbs into the gums with similar mechanism and hence it is comparable in terms of properties whereas mechanism of action for COE-pack material is completely different, as mentioned earlier it hardens after application.