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CTRI Number  CTRI/2024/05/067068 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of satranidazole and hyaluronic acid gels in addition to scaling and root planing for treatment of stage I and stage II periodontitis 
Scientific Title of Study   Clinical and microbiological efficacy of 3% satranidazole and 0.8% hyaluronic acid oral insitu gels as an adjunct to scaling and root planing in the treatment of stage 1 and stage 2 periodontitis.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Upputuri venga urekha 
Designation  Pg student  
Affiliation  Sibar institute of dental sciences 
Address  Room no 8,second floor department of periodontics sibar institute of dental sciences takellapadu guntur andhrapradesh

Guntur
ANDHRA PRADESH
522509
India 
Phone  08639185751  
Fax    
Email  upputuriurekha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Boyapati ramanarayana 
Designation  Professor 
Affiliation  Sibar institute of dental sciences 
Address  Room no 8,second floor department of periodontics sibar institute of dental sciences takellapadu guntur andhrapradesh 522509

Guntur
ANDHRA PRADESH
522509
India 
Phone  9490144365  
Fax    
Email  dr.ramanarayana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Boyapati ramanarayana 
Designation  Professor 
Affiliation  Sibar institute of dental sciences 
Address  Room no 8,second floor department of periodontics sibar institute of dental sciences takellapadu guntur andhrapradesh 522509

Guntur
ANDHRA PRADESH
522509
India 
Phone  9490144365  
Fax    
Email  dr.ramanarayana@gmail.com  
 
Source of Monetary or Material Support  
Sibar institute of dental sciences and hospital,Takellapadu,Guntur 
 
Primary Sponsor  
Name  Upputuri venga urekha 
Address  Room no 8,second floor department of periodontics sibar institute of dental sciences takellapadu guntur andhrapradesh 522509 
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 
Upputuri venga urekha  Sibar institute of dental sciences  Room no 8,second floor department of periodontics sibar institute of dental sciences takellapadu guntur andhrapradesh 522509
Guntur
ANDHRA PRADESH 
08639185751

upputuriurekha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.8% hyaluronic acid oral insitu gel  After scaling and root planing oral insitu gels are placed in the periodontal pocket 
Intervention  3% satranidazole oral insitu gels  After scaling and root planing oral insitu gels are placed in the periodontal pocket 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Age group of 35-55 years of both the gender.
2.Apparently Healthy individuals
3.Subjects with Stage I (Interdental CAL – 1 to 2 mm, radiographic boneloss less than 15% of coronal third, maximum probing depth less than or equal to 4mm) and Stage II periodontitis (Interdental
CAL – 3 to 4mm, radiographic bone loss 15- 33% of coronal third, maximum probing depth less than or equal to 5mm)
4.Subjects who are willing to give informed consent.
 
 
ExclusionCriteria 
Details  1. Subjects using any form of tobacco.
2. History of previous antibiotic therapy within the past 3 months
3. Subjects who has history of drug allergy.
4. Pregnant woman and Lactating mothers.
5. Subjects with Stage III and Stage IV periodontitis.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in probing depth ,gain in clinical attachment levels and bacterial count  Baseline 1 month 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased plaque and gingival score  Baseline 1 month 3 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 4 
Date of First Enrollment (India)   02/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Periodontitis is an oral disease characterized by microbially associated, host mediated inflammation in the periodontium. In the pathophysiology of periodontitis, the loss of marginal periodontal ligament fibres is observed, junctional epithelium, migrates apically which causes biofilm to spread in apical direction along root surface. Treatment to manage periodontal disease can involve  mechanical debridement, which includes scaling and root planing (SRP) 

At the initial visit, a clinical examination will be performed on each patient and clinical parameters such as plaque index, gingival index, pocket depth and clinical attachment level will be recorded. At baseline all the patients will receive phase I therapy which includes Supragingival scaling and thorough oral hygiene instructions. Patients will be recalled after one week for Subgingival plaque sample collection. One week after scaling and root planning, baseline subgingival plaque sample will be collected using sterile curettes. The collected sample will be immediately transferred to a transport medium and sent to laboratory for microbiological analysis of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa) by using multiplex PCR.

   In Group A subgingival scaling and root planing will be done and satranidazole gel is placed. In Group B after subgingival scaling and root planing hyaluronic acid gel will be injected into the pocket until the material is detected at the gingival margin. Then periodontal dressing (coe-pak) will be placed on treated site to ensure that gel will stay long enough to be effective in the pocket. After one-week periodontal dressing is removed.

   Clinical parameters will be recorded after 1 month and 3 months after treatment and post operative subgingival plaque samples will be collected from two groups and sent for microbiological analysis after 3 months.


 
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