| CTRI Number |
CTRI/2026/04/108559 [Registered on: 16/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing use of Fibrin Glue, made from own blood, and silk Sutures to check healing and time taken for wound closure in patients undergoing gum surgery.
|
|
Scientific Title of Study
|
Evaluation of Clinical Parameters and Patient-centric Outcomes of Periodontal Flap Closure using Autologous Fibrin Glue and Silk sutures, in Stage II Grade B Periodontitis patients: A Split-mouth 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 |
Harshandi Bodele |
| Designation |
PG Student |
| Affiliation |
MGV KBH Dental College and Hospital Nashik |
| Address |
Department of Periodontology and implantology/303
Nashik
MAHARASHTRA
422003
India |
| Phone |
9834113672 |
| Fax |
|
| Email |
harshandi05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Agrawal |
| Designation |
Professor |
| Affiliation |
MGV KBH Dental College and Hospital Nashik |
| Address |
Department of Periodontology and Implantology/303
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822107562 |
| Fax |
|
| Email |
agrodent@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshandi Bodele |
| Designation |
PG student |
| Affiliation |
MGV KBH Dental College and Hospital Nashik |
| Address |
Department of Periodontology And Implantology/303
Nashik
MAHARASHTRA
422003
India |
| Phone |
9834113672 |
| Fax |
|
| Email |
harshandi05@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Harshandi Bodele |
| Address |
Plot no 26, Jeevan Jyoti, Vaidya Layout, Nagpur. |
| 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 |
| Harshandi Bodele |
MGV KBH Dental College and Hospital, Nashik |
Department of Periodontology and Implantology/303
Nashik
MAHARASHTRA |
9834113672
harshandi05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental College- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Fibrin Glue |
(Autologous Fibrin Glue – Test Group)
Autologous fibrin glue will be prepared chairside from 10 ml of the patient’s own blood collected in sterile sodium-citrate vacutainers. The sample will be centrifuged at 3000 rpm for 10 minutes to separate platelet-poor plasma, platelet-rich plasma, and red cell fraction. The plasma fractions will be transferred to a sterile tube and mixed with protamine sulphate (10 mg/ml) to precipitate fibrinogen, followed by a second centrifugation at 3000 rpm for 5 minutes. The upper serum layer containing autologous thrombin will be partially discarded, and the fibrinogen precipitate will be diluted with 0.5 ml of retained serum. Equal volumes of fibrinogen solution and calcium chloride (0.025 mmol/l) will be loaded into syringes and applied beneath the repositioned periodontal flap. Digital pressure will be maintained for 2–3 minutes to allow adhesive polymerization. The flap will be stabilized without sutures. Time taken for flap closure, immediate tissue stability, and follow-up healing will be recorded as per study protocol |
| Comparator Agent |
Silk Suture |
(Silk Sutures – Control Group)
In the control group, periodontal flap closure will be performed using conventional 3-0 or 4-0 black braided silk sutures following completion of localized flap surgery. After flap repositioning, interrupted sutures will be placed to achieve complete flap adaptation and stability. Standard postoperative flap closure protocol will be followed, ensuring tension-free approximation of wound margins. The time taken for flap closure will be recorded using a digital timer. Immediate postoperative tissue stability will be evaluated using the roll test, and wound healing will be assessed at 1 week and 1 month using the simplified healing index. Sutures will be removed after 1 week as per standard clinical protocol. Patient-reported outcomes related to discomfort, anxiety, and suture removal will be recorded using the Visual Facial Anxiety Scale. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject aged between 20 to 40 years.
2. Systemically healthy patients.
3. Localized flap surgery indicated in atleast two non-adjacent areas in same arch in same patient, requiring flap surgery in 3 teeth per site.
4. Patient with haemoglobin levels more than 12g/dl.
|
|
| ExclusionCriteria |
| Details |
1. Flap surgery requiring regenerative/augmentation procedures.
2. Pregnant and lactating patients.
3. Tobacco chewers and smokers.
4. Anaemic patients.
5. Patient with any bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Simplified Wound Healing Index |
Post-Operative at 1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tissue Stability With Roll test |
Post-Operative Immediately |
| Patient Centric Treatment Outcome with Visual Facial Anxiety Scale |
At 1 month |
| Time Taken for Wound Closure |
immediately Post-op |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/06/2026 |
| 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="5"
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
|
This split-mouth randomized controlled clinical trial evaluates the effectiveness of autologous fibrin glue compared with conventional silk sutures for periodontal flap closure in Stage II Grade B periodontitis patients aged 20–40 years. Sutures, though commonly used, may increase plaque retention, postoperative discomfort, tissue reactivity, and patient anxiety. Autologous fibrin glue, prepared chairside from the patient’s own blood, offers a biological, suture-less alternative that may enhance healing, reduce discomfort, shorten closure time, and improve patient acceptance.
In each participant, two non-adjacent flap surgery sites are randomly allocated to either autologous fibrin glue (test) or silk sutures (control). Primary outcomes include time taken for wound closure, immediate postoperative tissue stability assessed by roll test, and wound healing at 1 week and 1 month using a simplified healing index. Secondary outcomes include patient-centric measures such as anxiety during wound closure, intra-operative and postoperative discomfort, anxiety related to suture removal, and discomfort during suture removal, assessed using the Visual Facial Anxiety Scale.
The study seeks to determine whether autologous fibrin glue provides comparable or superior clinical and patient-reported outcomes as a suture-less flap closure technique. By assessing both clinical parameters and patient experience, this trial aims to identify a more comfortable and efficient method for periodontal flap closure. |