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CTRI Number  CTRI/2021/04/032472 [Registered on: 01/04/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE STUDY BETWEEN 1% ALENDRONATE GEL AND 1% METFORMIN GEL IN THE TREATMENT OF PYORRHEA. 
Scientific Title of Study   COMPARATIVE STUDY BETWEEN 1% ALENDRONATE GEL AND 1% METFORMIN GEL IN THE TREATMENT OF INFRA BONY DEFECTS IN PATIENTS WITH CHRONIC PERIODONTITIS- IN AN VIVO STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipika Mitra 
Designation  Professor and HOD  
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipika Mitra 
Designation  Professor and HOD  
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chaitrali Lakade 
Designation  Post graduate student 
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Terna Dental College and Hospital Plot No. 12 , Sector 22,Opp.Nerul west Railway station ,Nerul west, Navi Mumbai.
Mumbai
MAHARASHTRA
400706
India 
Phone  9284612744  
Fax    
Email  chaitralilakade19@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Terna Dental college 
Address  Terna Dental college and Hospital plot no.12, sector 22,Opp.Nerul west railway station,Nerul,Navi Mumbai.Maharashtra 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chaitrali lakade  TPCTs Terna Dental College  Department of periodontics, room no. 101, Plot No. 12, Sector–22, Opp. Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706 Mumbai MAHARASHTRA Thane MAHARASHTRA
Mumbai
MAHARASHTRA 		 9284612744

chaitralilakade19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy individuals with Infra Bony defects in patients with chronic periodontitis.  
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1% Metformin gel.  1% Metformin gel will be placed in infrabony defects, after flap reflection and debridement, in patients with chronic periodontitis  
Intervention  1% Alendronate gel   1% Alendronate gel will be placed in infrabony defects, after flap reflection and debridement, in patients with chronic periodontitis  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with periodontal disease with a possible indication for flap surgery and having at least two intra bony defects, one on either side of the same arch, with interproximal probing depth (PD) of at least 5 mm or more after phase I therapy.
2.Patients maintaining proper oral hygiene status.
3.Systemically healthy patients.
4.Patients who give informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating females.
2.Patients consuming tobacco in any form.
3.Patients who have undergone periodontal surgical therapy in the last 6 months in the same site.
4.Systemic disease or other conditions that could influence the periodontal status.
5.Allergy to bisphosphonates or history of their systemic use.
6.Unwillingness to return for follow –up.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Probing pocket depth (PPD) and, gain in relative attachment level (RAL),change in height of alveolar bone crest and bone fill.  Baseline
3 month
6 month
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Probing pocket depth (PPD) and gain in relative attachment level (RAL), change in height of alveolar bone crest and bone fill between the sites treated with 1% alendronate gel or with 1% metformin gel.  Baseline
3 month
6 month 
 
Target Sample Size   Total Sample Size="13"
Sample Size from India="13" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="13" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="21"
Months="10"
Days="17" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
To evaluate and compare clinically and radiographically, the efficacy of 1% Alendronate gel with 1% Metformin gel in the treatment of infra bony defects in patients suffering from chronic periodontitis. This is a clinical trial to evaluate and compare the difference between the reductions in probing pocket depth(PPD), gain in attachment level, change in height of alveolar bone crest and  bone fill between the sites treated with 1% Alendronate gel and 1% metformin gel, that will be conducted in Terna Dental College, India. Evaluation will be done at  baseline, 3 and 6 months after surgery.
 
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