| CTRI Number |
CTRI/2026/04/107653 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Sutures Coated with Medicament Versus Plain Silk Sutures in Periodontal Flap Surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Antimicrobial Coated Versus Non-Coated Silk Sutures in Periodontal Flap Surgery: 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 |
Dr Samra Shaikh |
| Designation |
Post graduate student |
| Affiliation |
JMFs ACPM Dental College |
| Address |
Department of Periodontology, Room No 3 Annasaheb Chudaman Patil Memorial Dental College, Sakri road, Dhule, Tal.Dist-Dhule, Affiliated to MUHS Nashik. Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8554042554 |
| Fax |
02562279924 |
| Email |
shaikhsamra1119@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalitha Shiggaon |
| Designation |
Professor |
| Affiliation |
JMFs ACPM Dental College |
| Address |
Department of Periodontology, Room No 3 Annasaheb Chudaman Patil Memorial Dental College, Sakri road, Dhule, Tal.Dist-Dhule, Affiliated to MUHS Nashik. Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8408876666 |
| Fax |
02562279924 |
| Email |
drlalithavk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalitha Shiggaon |
| Designation |
Professor |
| Affiliation |
JMFs ACPM Dental College |
| Address |
Department of Periodontology, Room No 3 Annasaheb Chudaman Patil Memorial Dental College, Sakri road, Dhule, Tal.Dist-Dhule, Affiliated to MUHS Nashik. Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
8408876666 |
| Fax |
02562279924 |
| Email |
drlalithavk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Annasaheb Chudaman Patil Memorial Dental college, Department of periodontology, Room No. 3, Sakri road, Dhule, tal.Dist.-Dhule, pin-424001 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr. Samra Shaikh |
| Address |
Annasaheb Chudaman Patil Memorial Dental college, Department of periodontology, Room No. 3, Sakri road, Dhule, tal.Dist.-Dhule, pin-424001. country-Maharashtra. |
| 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 Samra Shaikh |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College Dhule |
Department of Periodontology and Oral Implantology, room no.3, Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College Dhule, Maharashtra
Dhule
MAHARASHTRA |
8554042554
02562279924
shaikhsamra1119@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Annasaheb Chudaman Dental College Dhule Institutional Ethics Committee |
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 |
Ciprofloxacin loaded with gold nanoparticles coated 3-0 silk suture in periodontal flap surgery and
Ciprofloxacin coated 3-0 silk suture in periodontal flap surgery. |
Group A:
[Ciprofloxacin-loaded gold nanoparticles coated 3-0 silk suture (CPG-NPs)]
After recording all clinical parameters at baseline, periodontal flap surgery will be performed under local anaesthesia.
Following aseptic preparation, crevicular incisions will be given and a full-thickness mucoperiosteal flap will be reflected.
Thorough scaling and root planing will be performed.
The flap will be repositioned and sutured using Ciprofloxacin- loaded gold nanoparticles (CPG-NPs) coated 3-0 silk sutures
Periodontal dressing will be placed if indicated.
Group B :
( Ciprofloxacin-coated 3-0 silk suture)
After recording all clinical parameters at baseline, periodontal flap surgery will be performed under local anaesthesia using the same surgical protocol as Group A.
Following aseptic preparation, crevicular incisions will be given and a full-thickness mucoperiosteal flap will be reflected.
Thorough scaling and root planing will be performed.
The flap will be repositioned and sutured using Ciprofloxacin-coated 3-0 silk sutures.
Periodontal dressing will be placed if indicated.
|
| Comparator Agent |
Non-coated 3-0 silk suture in periodontal flap surgery |
Group C:
(Non-coated 3-0 silk suture)
After recording all clinical parameters at baseline, periodontal flap surgery will be performed under local anaesthesia using the same surgical protocol as Groups A and B.
Following aseptic preparation, crevicular incisions will be given and a full-thickness mucoperiosteal flap will be reflected.
Thorough scaling and root planing will be performed.
The flap will be repositioned and sutured using non-coated 3-0 silk sutures.
Periodontal dressing will be placed if indicated.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group between 25-50 years of age.
2. Patients indicated for periodontal flap surgery (more than 5mm residual probing depth after Phase 1 therapy)
3. Systemically healthy patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases and those on medication for the same.
2. Pregnant and/or lactating women.
3. Patients with deleterious oral habits such as smoking or tobacco use.
4. Patients with any known allergy to Ciprofloxacin.
5. Patients who have received antibiotics in any form or have undergone major surgical procedures and received antibiotic therapy for the same within the past 3 months.
6. Patients unwilling to participate in the study or those not willing to comply with the follow-up schedule.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the clinical healing, plaque accumulation, and microbial colonization associated with ciprofloxacin-loaded gold nanoparticle–coated (CPG-NP), ciprofloxacin-coated and non-coated 3-0 silk sutures following periodontal flap surgery. |
Assessing the clinical healing on 8th day ,plaque accumulation on 8th day, and microbial colonization on 8th day associated with ciprofloxacin-loaded gold nanoparticle–coated (CPG-NP), ciprofloxacin-coated and non-coated 3-0 silk sutures following periodontal flap surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess & compare postoperative pain following the use of ciprofloxacin-loaded gold nanoparticle–coated (CPG-NP), ciprofloxacin-coated & non-coated 3-0 silk sutures in periodontal flap surgery. |
postoperative pain assessment on 8th day following the use of ciprofloxacin-loaded gold nanoparticle–coated (CPG-NP), ciprofloxacin-coated & non-coated 3-0 silk sutures following periodontal flap surgery. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [shaikhsamra1119@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 01-03-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a Triple-blind randomized clinical trial designed to evaluate and compare clinical healing, plaque accumulation, and microbial colonization associated with ciprofloxacin-loaded gold nanoparticle-coated (CPG-NP), ciprofloxacin-coated, and non-coated 3-0 silk sutures following periodontal flap surgery. The study aims to test the hypothesis that nanoparticle-based antibiotic-coated sutures may provide improved clinical healing and reduced microbial colonization compared with conventional sutures. The primary outcome measures include plaque accumulation assessed using the Visible Plaque Index, early wound healing assessed using the Early Wound Healing Index, and microbial colonization determined by colony-forming unit (CFU) analysis of retrieved sutures on 8th day following periodontal flap surgery for all the groups. The secondary outcome measures include postoperative pain, which will be assessed by the number of analgesic tablets consumed by the patient and by the Visual Analogue Scale (VAS) on the 8th postoperative day following periodontal flap surgery for all the groups. |