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CTRI Number  CTRI/2024/07/071666 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assess efficacy of chlorhexidine coated silk suture after gum surgery. 
Scientific Title of Study   Comparative evaluation of antimicrobial efficacy of chlorhexidine coated silk suture with uncoated silk suture in subjects with stage II and stage III grade B periodontitis in periodontal flap surgery - A randomized 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  Pandurang Gulabrao Gavhale 
Designation  Postgraduate Student 
Affiliation  Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai 
Address  Dept of Periodontology, Room no. 3, Institution Area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9665054917  
Fax    
Email  panduranggavhale2050@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nupur Sah 
Designation  Professor of Periodontology 
Affiliation  Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai 
Address  Institution Area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9769048494  
Fax    
Email  sahnupur02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pandurang Gulabrao Gavhale 
Designation  Postgraduate student 
Affiliation  Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai 
Address  Institution Area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9769048494  
Fax    
Email  panduranggavhale2050@gmail.com  
 
Source of Monetary or Material Support  
Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar Navi Mumbai Institution Area Sector 4, Kharghar, Navi Mumbai 410210 
 
Primary Sponsor  
Name  Pandurang Gulabrao Gavhale 
Address  Department of Periodontology YMT dental college and hospital, room no. 3, sector 4, near railway station, Kharghar, Navi Mumbai, Maharashtra, India 410210 
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 
Dr Pandurang Gulabrao Gavhale  Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai  Dept of Periodontology and Oral Pathology of Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai Institution Area Sector 4 Kharghar, Navi Mumbai 410210
Raigarh
MAHARASHTRA 
9665054917

panduranggavhale2050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comitee YMT Dental College and Hospital, Kharghar, Navi Mumbai  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  Chlorhexidine coated silk suture used in periodontal flap surgery  At Day 0 - Plaque Index and Gingival Index will be assessed At Day 7- Total colony forming units, Wound Healing Index, Plaque Index and Gingival Index will be assessed At Day 21- Plaque Index and Gingival Index will be assessed 
Comparator Agent  Silk suture  At Day 0 - Plaque Index,and Gingival Index will be assessed At Day 7- Total colony forming units, Wound Healing Index, Plaque Index and Gingival Index will be assessed At Day 21- Plaque Index and Gingival Index Will be assessed 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Subjects with at least 20 teeth present.

2)Systemically healthy subjects of either sex, not under any medication affecting the periodontal treatment outcome.

3)Subjects with probing pockets depth of ≥ 5mm with atleast 2 teeth and on both sides of the same arch after phase I therapy.

4)Subjects willing to be a part of the study without any objection.
 
 
ExclusionCriteria 
Details  1)Subjects with history of antibiotic and/or anti-inflammatory drugs in the past 3 months.

2)Pregnant women, women on oral contraceptive medication and lactating mothers.

3)Subjects who are smokers and/or tobacco chewers.

4)Subjects who have undergone any periodontal therapy in past 6 months.

5)Noncompliant subjects
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the antimicrobial efficacy of chlorhexidine coated silk suture with respect to Colony forming units.  Assessed on day 7 after Periodontal flap surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the antimicrobial efficacy of chlorhexidine coated silk suture after periodontal flap surgery with respect to
wound healing index
plaque index
gingival index 
Baseline
on day 7
day 21 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/08/2024 
Date of Study Completion (India) 15/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/12/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [panduranggavhale2050@gmail.com].

  6. For how long will this data be available start date provided 11-03-2025 and end date provided 11-03-2060?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - panduranggavhale2050@gmail.com
Brief Summary  
The primary goal of periodontal therapy is to arrest the progression of periodontal disease, and regeneration of lost periodontal tissues and maintain the natural dentition in health and comfortable function.      This goal can be accomplished by non-surgical therapy in patients with mild to moderate periodontitis, whereas in advanced cases, open flap debridement in greater success.

            Periodontal flaps provide access for root instrumentation, osseous reduction and periodontal regeneration. Optimal flap stabilization promotes the early formation and organization of a blood clot and consequently ensures that the delicate fibrin clot adheres to the hard, non-shedding wound-bed surface. Hence, stabilization and adaptation of the soft tissues covering the wound area with appropriate suturing appears to be a key prerequisite for achieving optimal surgical outcomes. The main problem, however, in the oral cavity is the prolonged immersion of suture in the saliva-containing microorganisms. Once suture material becomes contaminated, biologic agents, chemical agents, or other mechanisms of wound decontamination become ineffective owing to biofilm formation and the subsequent protection it affords to biofilm populations. Sutures can be a source of surgical wound contamination owing to bacterial adherence to them and the suture acting as a means of transmitting bacteria to oral tissues. Silk Sutures are multifilament sutures and requiring more knots and have more tendency than monofilament to absorb the oral liquids fluids and consequently microorganisms into the connective tissue. This results in continuous wicking of microorganisms along the suture at the surgical site which results in a prolonged inflammatory response and surgical site infections.

Development of an antibacterial suture has been under consideration for many years. Sutures impregnated or coated with antibacterial agents have been developed in an attempt to reduce bacterial adherence and colonization. Local drug delivery in the form of coated sutures can be an effective method to inhibit biofilm formation and decrease the bacterial load at the surgical site, thereby reducing the need to give any systemic antibiotics and eliminating the need of antimicrobial mouthwash post-surgery. Moreover, the reduced biofilm formation near the surgical site can also improve the clinical success of any surgery.

Chlorhexidine considered as the “gold standard” in oral antiseptics can be used as it is effective against a broad spectrum of pathogens. At low concentration it acts as a bacteriostatic and at higher concentration it acts as a bactericidal agent. A silk suture coated with the chlorhexidine gel can thus be used. Hence this study is designed to assess chlorhexidine coated silk sutures in periodontal flap surgery.

                           The aim of the present study is to evaluate and compare the wound healing and antimicrobial efficacy of chlorhexidine coated silk suture with uncoated silk suture in subjects with stage II and stage III grade B periodontitis undergoing periodontal flap surgery. 
 
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