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CTRI Number  CTRI/2024/08/073139 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Mangosteen Gel for Enhanced Periodontitis Treatment: A Full-Mouth Disinfection Clinical Trial 
Scientific Title of Study   Evaluation of Effectiveness of Mangosteen gel as an Adjunct to One-Stage Full-Mouth Disinfection in Periodontitis: A Clinical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivani Thakre 
Designation  Post Graduate Student 
Affiliation  Sharad Pawar Dental College 
Address  Room no.003, Ground floor, Department of Periodontology and Implantology
Sharad Pawar Dental College, DMIHER, Sawangi(Meghe), Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India 
Phone  08788271171  
Fax    
Email  thakareshivani21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pavan Bajaj 
Designation  Associate Professor 
Affiliation  Sharad Pawar Dental College 
Address  Room no.003, Ground floor, Department of Periodontology and Implantology
Sharad Pawar Dental College, DMIHER, Sawangi(Meghe), Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India 
Phone  8412045019  
Fax    
Email  pavbajaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pavan Bajaj 
Designation  Associate Professor 
Affiliation  Sharad Pawar Dental College 
Address  Room no.003, Ground floor, Department of Periodontology and Implantology
Sharad Pawar Dental College, DMIHER, Sawangi(Meghe), Wardha 442001, Maharashtra
Wardha
MAHARASHTRA
442001
India 
Phone  8412045019  
Fax    
Email  pavbajaj@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha-442001, Maharashtra, India 
 
Primary Sponsor  
Name  Sharad Pawar Dental College SawangiMeghe 
Address  Sawangi (Meghe), Wardha-442001, Maharashtra, India 
Type of Sponsor  Private medical college 
 
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 Shivani Thakre  Sharad Pawar Dental College, Sawangi(Meghe)  Room no. 003, Department of Periodontology and Implantology, Sharad Pawar Dental College, DMIHER, Sawangi
Wardha
MAHARASHTRA 		 08788271171

thakareshivani21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee DMIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Full-mouth Disinfection using Chlorhexidine  Conventional Full-mouth Disinfection using Chlorhexidine . All pockets will be irrigated (three times within 10 min.) with a 0.2% CHX solution  
Intervention  Mangosteen gel  After completion of Full-mouth Disinfection, we will place 4% Mangosteen gel in loaded into a hypodermic syringe with a 24gauge angulated blunt needle and delivered to the sites, respectively.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Generalized interproximal attachment loss involving at least three teeth apart from molars and first incisors.
2. Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
3. Patients with a minimum number of 20 teeth.
4. Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth.
5. The patients included in the study should be systemically healthy.
6. Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
7. Patients motivated to have the therapy and willing to complete the follow-up.
 
 
ExclusionCriteria 
Details  1. Patients with a known or suspected allergy
2. Patients who have undergone periodontal therapy in the last 6 months.
3. Patients with any systemic disorder affecting periodontal health.
4. Patients with infectious conditions other than periodontitis.
5. Chronic alcoholics
6. Patients consuming tobacco in any form and smokers.
7. Immuno-compromised and systemically-unhealthy patients.
8. Pregnant or lactating females.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Use of Mangosteen adjunct to Full Mouth Disinfection may lead to better outcomes  Assesment will be done at baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Full-mouth disinfection is a treatment method for periodontitis. The aim of this treatment is to manage periodontal pockets by preventing infection of periodontal pathogens and intraoral bacterial reservoirs, such as tonsils, tongue, and other mucous membranes, that could lead to a disease recurrence. In this method, the entire mouth is disinfected in a single session, which includes scaling and root planing (SRP) and the use of antimicrobial agents such as chlorhexidine (CHX). In this study, 30 patients will be equally distributed in two different groups. Group A (n=15) will be alloted with conventional Full-mouth disinfection(FMD) and Group B(n=15) will undergo application of Mangosteen gel in periodontal pockets adjunt to conventional FMD. Expected outcomes will be the group with adjunct use of Mangosteen gel will give better results. 
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