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CTRI Number  CTRI/2021/11/038043 [Registered on: 15/11/2021] Trial Registered Prospectively
Last Modified On: 12/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Amfresh gel and Chlorhexidine gel as an adjunct to scaling and root planing in periodontitis patients. 
Scientific Title of Study   "Comparative evaluation of efficacy of combination of resveratrol, chitosan, neem and curcumin gel and Chlorhexidine gel as an adjunct to scaling and root planing (SRP) in patients with periodontitis- A randomised controlled clinical trial." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jui Bhandare 
Designation  PG STUDENT 
Affiliation  MGVs KBH Dental College and Hospital 
Address  301/302, Department of Periodontology, MGVs KBH Dental College and Hospital, Mumbai-Agra Highway, Panchavati, Nashik-03.

Nashik
MAHARASHTRA
422003
India 
Phone  8830750033  
Fax    
Email  jbdaree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swapna Mahale 
Designation  Professor and HOD, PhD scholar.  
Affiliation  MGVs KBH Dental College and Hospital 
Address  301/302, Department of Periodontology, MGVs KBH Dental College and Hospital, Mumbai-Agra Highway, Panchavati, Nashik-03.

Nashik
MAHARASHTRA
422003
India 
Phone  9422764080  
Fax    
Email  drsamahale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Katkurwar 
Designation  PG student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  301/302, Department of Periodontology, MGVs KBH Dental College and Hospital, Mumbai-Agra Highway, Panchavati, Nashik-03.

Nashik
MAHARASHTRA
422003
India 
Phone  8975916733  
Fax    
Email  katkurwarankita@gmail.com  
 
Source of Monetary or Material Support  
301/302, Department of Periodontology, MGVs KBH Dental college and Hospital, Panchavati, Nashik-03 
 
Primary Sponsor  
Name  Dr Swapna Mahale 
Address  301/302, Department of Periodontology, MGVs KBH Dental College and Hospital, Panchavati, Nashik-03. 
Type of Sponsor  Other [No sponsor- Self funding] 
 
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 Swapna Mahale  MGVs KBH Dental College and Hospital   301/302, Department of Periodontology,K.B.H. Dental College and Hospital, Mumbai Agra Road, Panchwati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA 		 9422764080

drsamahale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KBH Dental College-Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: Z515||Encounter for palliative care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amfresh gel  Combination of Resveratrol, Chitosan, Neem & Curcumin Dose: 1% w/w of Resveratrol, Chitosan, Neem & 0.05 % w/w of Curcumin depending upon the depth of the pocket Frequency: Once after scaling and root planing. Route of administration: Local drug delivery into the periodontal pocket. Duration of therapy: 3 months after the administration of drug into the pocket. 
Comparator Agent  Hexigel  Chlorhexidine gluconate Dose: 1% w/w Chlorhexidine gluconate depending upon the depth of the pocket Frequency: Once after scaling and root planing. Route of administration: Local drug delivery into the periodontal pocket. Duration of therapy: 3 months after the administration of drug into the pocket. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patient diagnosed with Generalised periodontitis stage 2 grade 2 currently unstable with no risk factor
2. Patients with persistent pocket depth of minimum 4 -6 mm having minimum of 2-3 sites.
3. Systemically healthy subjects. 
 
ExclusionCriteria 
Details  1. History of any previous periodontal therapy in the last 6 months.
2.Use of drugs such as antibiotics, anti-inflammatory, corticosteroids, chemotherapeutics or immunological modulators that might alter the expected response of the oral tissues.
3. Tobacco consumption in any form.
4. Systemic diseases influencing the periodontal disease.
5. Pregnant and lactating women.
6. Allergy to chlorhexidine and Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index (PI) (Silness J, Lo¨e H. 1964)
Probing Pocket Depth (PPD)
Relative Attachment Level (RAL) 		 Baseline, 1 month and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival Index (GI) (Loe and Silness, 1963)
Sulcus Bleeding Index.(SBI)(Muhlemann H.R & Son,1971) 		 Baseline, 1 month and 3 months. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 2 
Date of First Enrollment (India)   22/11/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsamahale@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

There are various local drug delivery systems available, but since long, Chlorhexidine has been one of the most effective topical antimicrobial agent used. However there are  some inevitable side effects of chlorhexidine like brown discoloration of teeth, some restorative materials and also dorsum of tongue , taste disturbances where the salty taste perception is particularly affected, oral mucosal erosion and unilateral or bilateral parotid swelling. Resveratrol has potent antioxidant, antitumor and anti-inflammatory effects that benefit the treatment of some diseases, such as cancer, diabetes, cardiovascular  disorders , degenerative diseases, autoimmune diseases and metabolic diseases. The combination of Resveratrol and  curcumin  have additive or possibly even synergistic effects with respect to host modulation.
 Hence this study will analyze the efficacy of Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel and chlorhexidine gel as a local drug delivery in periodontal pocket in chronic periodontitis patients 

 
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