| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [panduranggavhale2050@gmail.com].
- 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.
- 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. |