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CTRI Number  CTRI/2024/06/068727 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of locally delivered hyaluronic acid with tetracycline fiber for treatment of periodontitis in smokers. 
Scientific Title of Study   Comparative evaluation of the efficacy of locally delivered hyaluronic acid with tetracycline fiber as an adjunct to scaling and root planing for the treatment of periodontitis Stage II/III in smokers- A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarya Pratihari 
Designation  1st year PG Student 
Affiliation  K M Shah Dental College and Hospital 
Address  Department of Periodontology, Room no. 7, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Waghodia, Piparia

Vadodara
GUJARAT
391760
India 
Phone  6370967272  
Fax    
Email  aishu8701@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monali Shah 
Designation  Professor and Head 
Affiliation  K M Shah Dental College and Hospital 
Address  Department of Periodontology, Room no. 7,K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Waghodia, Piparia

Vadodara
GUJARAT
391760
India 
Phone  9824003228  
Fax    
Email  smonali2011@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aishwarya Pratihari 
Designation  1st year PG Student 
Affiliation  K M Shah Dental College and Hospital 
Address  Department of Periodontology, Room no. 7,K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Waghodia, Piparia

Vadodara
GUJARAT
391760
India 
Phone  6370967272  
Fax    
Email  aishu8701@gmail.com  
 
Source of Monetary or Material Support  
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara, Gujarat- 391760 
 
Primary Sponsor  
Name  Aishwarya Pratihari 
Address  Department of Periodontology, Room no. 7, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara, Gujarat- 391760 
Type of Sponsor  Other [Self-funded study] 
 
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 Aishwarya Pratihari  K M Shah Dental College  Room no. 7, Department of Periodontology, K M Shah Dental College, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara, Gujarat- 391760
Vadodara
GUJARAT 		 6370967272

aishu8701@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyaluronic acid  0.2% hyaluronic acid gel as local drug delivery. 
Comparator Agent  Tetracycline fiber  Tetracycline fiber as local drug delivery. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants diagnosed with periodontitis Stage II/III.
Participants who are current smokers, smoking ≥10 cigarettes/ bidis per day since at least 1 month.
Participants should not have received any periodontal therapy for past 6 months.
Participants who gave consent to participate in the study. 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Patients using anti-microbial mouthwash in the past 2 months.
Participants with allergy to hyaluronic acid.
Participants with systemic disease other than diabetes mellitus.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing depth
Clinical attachment level
Radiographic bone fill 		 4 weeks
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index
Sulcus bleeding index 		 4 weeks
12 weeks 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   N/A 
Date of First Enrollment (India)   20/06/2024 
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 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  
The prevalence, extent and severity of periodontitis is more in smokers. After surgical therapy there is less probing depth reduction, less gain in clinical attachment level, less bone fill and increased recession and deterioration of furcation. Hyaluronic acid has anti-inflammatory properties and is known to facilitate healing by inhibiting tissue destruction. Tetracycline fiber are known to exert an anticollagenase effect that can inhibit tissue destruction and may help with bone regeneration. Since, surgical therapy in smokers is less predictable, use of Hyaluronic acid and tetracycline fiber as an LDD can serve as an alternate treatment modality in such population.
 
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