| CTRI Number |
CTRI/2025/09/095379 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Healing After Gum Surgery: Comparing Tissue Glue Alone and Tissue Glue with Laser Therapy |
|
Scientific Title of Study
|
Evaluating and comparing the healing of periodontal flap using cyanoacrylate tissue adhesive alone and along with low level laser therapy |
| 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 Kratee Sharma |
| Designation |
Professor |
| Affiliation |
Kothiwal Dental College and Research Centre, Moradabad |
| Address |
Department of Periodontology, Room Number-3, First Floor, Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road, Moradabad, Uttar Pradesh, India
Department of Periodontology, Room Number-3, First Floor, Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7060945432 |
| Fax |
|
| Email |
drkratee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalabh Mehrotra |
| Designation |
Professor and Head |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre,TMU, Moradabad |
| Address |
Department of Periodontology, Room number-716, Sixth floor, Teerthanker Mahaveer Dental College and Research Centre,TMU,NH9, Delhi Road, Bagadpur, Moradabad
Department of Periodontology, Room number-716, Sixth floor, Teerthanker Mahaveer Dental College and Research Centre,TMU,NH9, Delhi Road, Bagadpur, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9758957151 |
| Fax |
|
| Email |
drshalabh.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalabh Mehrotra |
| Designation |
Professor and Head |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre,TMU, Moradabad |
| Address |
Department of Periodontology, Room number-716, Sixth floor, Teerthanker Mahaveer Dental College and Research Centre,TMU,NH9, Delhi Road, Bagadpur, Moradabad
Department of Periodontology, Room number-716, Sixth floor, Teerthanker Mahaveer Dental College and Research Centre,TMU,NH9, Delhi Road, Bagadpur, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9758957151 |
| Fax |
|
| Email |
drshalabh.dental@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Kothiwal Dental College and Research Centre, Mora Mustaqeem, Kanth road, Moradabad,244001 |
|
|
Primary Sponsor
|
| Name |
Dr Kratee Sharma |
| Address |
Kothiwal Dental College and Research Centre,Mora Mustaqeem,Kanth road, Moradabad,244001 |
| 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 |
| Kratee Sharma |
Kothiwal dental college and Research Centre |
Department of Periodontology, Room Number-3, First Floor, Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH |
7060945432
drkratee@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Review Board, Kothiwal Dental College and Research Centre, Moradabad |
Approved |
| Institutional Ethics and Review Board, Kothiwal Dental College and Research Centre, Moradabad |
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 |
Open flap debridement followed by application of Low level laser therapy and flap closure with cyanoacrylate (Iso-amyl cyanoacrylate) |
Intra-crevicular incision followed by reflection of the flap, debridement of the granulation tissues, application of low level laser therapy on inner side of flap with FONA LASER; power-0.5 W, wavelength-940 nm, energy-2.5 J, frequency-20 Hz, 320 micrometer laser tip(7mm length), duration-10 seconds followed by re-adaptation of flap with Iso-amyl cyanoacrylate |
| Comparator Agent |
Open flap debridement followed by flap closure with 3.0 silk sutures |
Intra-crevicular incision followed by reflection of the flap, debridement of granulation tissues, and re-adaptation of flap with 3.0 silk suture |
| Intervention |
Open flap debridement followed by flap closure with cyanoacrylate (Iso-amyl cyanoacrylate) |
Intra-crevicular incision followed by reflection of the flap, debridement of granulation tissues, and re-adaptation of flap with Iso-amyl cyanoacrylate |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Residual probing depth 5-8 mm
2) Good level of oral hygiene after initial therapy
3) No discrimination of gender,caste,religion or socio-economic status |
|
| ExclusionCriteria |
| Details |
1) Medically compromised patients
2) Mentally disabled and physically handicapped patients
3) Smokers
4) Pregnant women and lactating mothers
5) Presence of acute periodontal or endodontic infections in the proposed surgical area
6) Known allergy to cyanoacrylate
7) History of radiation therapy or chemotherapy within the past year
8) Patients who are uncooperative, unwilling to participate in study and not maintaining oral hygiene properly
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal healing assessed using Wound Healing Index (Huang et al., 2005) |
Post-operative Day 3, Day 7, Day 14 and Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Postoperative pain using Visual Analogue Scale(VAS)
2) Reduction of Probing pocket depth(PPD)
3) Plaque accumulation by Turesky- Gilmore- Glickman modification of Quigley Hein Plaque Index 1970 |
Before intervention, Post-operative Day 3, Day 7, Day 14, Day 21, Day 42 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkratee@gmail.com].
- For how long will this data be available start date provided 03-11-2025 and end date provided 03-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
The present study is a prospective, randomized, controlled, single blinded, parallel-group clinical trial that aims to compare three different flap closure techniques: (i) conventional silk sutures, (ii) iso-amyl cyanoacrylate adhesive, and (iii) iso-amyl cyanoacrylate adhesive combined with Low-Level Laser Therapy (940 nm diode laser, 0.5 W, contact mode, 10 seconds). After Phase 1 therapy and re-evaluation, a total of 60 patients requiring flap surgery for chronic periodontitis will be recruited and randomly allocated into three groups, 20 each ; Group A:- Flap closure with braided silk 3-0 sutures (Ethicon Mersilk, Johnson & Johnson Pvt. Ltd.); Group B:- Flap closure with cyanoacrylate (Iso-amyl cyanoacrylate); Group C:- Flap closure with cyanoacrylate (Iso-amyl cyanoacrylate) with prior application of LLLT. Clinical parameters will be assessed at baseline and during follow-up. The primary outcome will be the Wound Healing Index (recorded at 3rd day, 1 week, 2 weeks, and 3 weeks). Secondary outcomes include postoperative pain using the Visual Analogue Scale (VAS) at the same time intervals, Periodontal Pocket Depth (PPD) at baseline and 6 weeks, and the Turesky–Gilmore–Glickman Plaque Index at baseline and 6 weeks. Patients are blinded to group allocation to reduce bias, and outcome aims to assess a minimally invasive alternative for flap closure. Data will be statistically analyzed, with significance set at p<0.05.
|