FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062326 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the healing ability of two gels on the gum wounds that gets exposed after the treatment. 
Scientific Title of Study   Comparative evaluation of BlueM gel with hyaluronic acid gel as wound healing agents for topical application following gingivectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Riddhi pareshbhai vyas 
Designation  postgraduate student, 2nd year 
Affiliation  Manipal College of Dental Sciences, MAHE, Manipal 
Address  Periodontology dept., Manipal College of Dental Sciences, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7265963646  
Fax    
Email  vyas.mcodsmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. santhosh kumar 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, MAHE, Manipal 
Address  Periodontology dept., Manipal College of Dental Sciences, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9741968550  
Fax    
Email  santhosh.kumar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Riddhi pareshbhai vyas 
Designation  postgraduate student, 2nd year 
Affiliation  Manipal College of Dental Sciences, MAHE, Manipal 
Address  Periodontology dept., Manipal College of Dental Sciences, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7265963646  
Fax    
Email  vyas.mcodsmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Manipal,MAHE 
 
Primary Sponsor  
Name  Riddhi pareshbhai vyas 
Address  Manipal College of Dental sciences. Manipal 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riddhi vyas  Manipal College of Dental sciences, Manipal  room 3, dept. of Periodontology,Manipal College of Dental sciences, Manipal
Udupi
KARNATAKA 		 7265963646

vyas.mcodsmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAHE, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  blue m gel  A team of dental surgeons in Netherlands recently developed an active oxygen formula (BlueM gel), with impressive results via the interaction of its active ingredients honey enzymes and sodium perborate. It has the particularity to release oxygen at a therapeutic concentration in the affected tissues. Several studies have shown significant wound healing potential of this novel formulation and neovascularization and pain reduction when applied topically post-operatively. It is available commercially. 0.1 ml of the gel to be applied over the surgical site topically for 3 times a day for 7 days. 
Intervention  Hyaluronic acid gel  Hyaluronic acid is a linear polysaccharide which consists of alternating units of D-glucuronic acid and N-acetyl-D-glucosamine linked by 11-3 and 11-4 linkages. Many studies have shown its beneficial effect on wound healing following periodontal surgery along with subsequent reduction of pain post-operatively. 0.1 ml of the gel to be applied over the surgical site topically for 3 times a day for 7 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient who underwent gum surgery of 2 or more teeth for functional crown lengthening procedure are
considered. 
 
ExclusionCriteria 
Details  The exclusion criteria involve participants that used drugs that could directly interfere with the
tissue response, such as anticoagulants and antiplatelet agents, participants who have been on antibiotic or anti-inflammatory therapy
in the past three months, diabetics, smokers, pregnant and lactating mothers, irradiated patients are considered excluded 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
healing of surgical site assessed by early wound healing index by lorenzo and wound healing index by landry  to be examined every 1st, 2nd and 3rd week 
 
Secondary Outcome  
Outcome  TimePoints 
patient outcome for post-operative pain  to be examined after 1st, 2nd and 3rd day by numeric rating scale over telephone 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 01/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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). 5) 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. 
Close