| CTRI Number |
CTRI/2026/01/102263 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical comparision of treatment of Class I and II gingival recession |
|
Scientific Title of Study
|
Clinical evaluation of treatment on class I and II gingival recession with subepithelial connective tissue graft with and without low-level laser therapy- a split-mouth 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 |
Pooja Hungund |
| Designation |
Post graduate student in Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Department of Periodontology, 2nd floor, Room no- 3, NH-44, Hosur road, cluster, Bommanahalli, near Hongasandra metro station, Bengaluru
The Oxford Dental College, Department of Periodontology, 2nd floor, Room no- 3 NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
07019971357 |
| Fax |
|
| Email |
drpoojahungund@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B. S. Jagadish Pai |
| Designation |
Professor and Head, Department of Periodontology Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru
The Oxford Dental College, NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru - 560068
KARNATAKA
560068
India |
| Phone |
07019971357 |
| Fax |
|
| Email |
bsjpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Hungund |
| Designation |
Post graduate student in Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Department of Periodontology, 2nd floor, Room no- 3, NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru
The Oxford Dental College, Department of Periodontology, 2nd floor, Room no- 3, NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
07019971357 |
| Fax |
|
| Email |
drpoojahungund@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pooja Hungund |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster B, Bommanahalli, near Hongasandra metro station, Bengaluru - 560068 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pooja Hungund |
The oxford dental college |
The Oxford Dental College, NH-44, Hosur road, cluster b, Bommanahalli, Near Hongasandra metro station, Bengaluru
Bangalore
KARNATAKA |
07019971357
drpoojahungund@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with Miller Class 1 and class 2 gingival recession |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
with Laser at the site of surgery for 10sec on the day of surgery and on 7th day post-operatively |
: After stabilizing the recipient site, LLLT will be performed in a continuous wave and a non-contact mode at 0.3 watts and energy density not more than 4 J/cm2 for 10 seconds on the day of surgery and on 7th day post-operatively. The type of laser used will be 810 nm diode laser. |
| Comparator Agent |
without laser |
Following adequate local anaesthesia, root debridement and polishing of the denuded root surface will be done. Pouch and Tunnel technique will be performed as described by Sculean and Allen for both groups. A full-thickness mucoperiosteal pouch and tunnel will be created using Orban’s knife which extend beyond the mucogingival junction, and interdental papillae will be elevated completely from the bone and also creating a tunnel laterally on the adjacent teeth. All the muscle fibers will be separated and released to achieve a tension free flap which could be easily mobilized coronally. After recipient preparation, a SCTG of a thickness of 1.5–2 mm will be harvested from the palate. The donor site will be closed by interrupted sutures. The CTG will be positioned in the tunnel covering the denuded recession area. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who agreed to participate in the study by signing the written informed consent.
2. Patients with an age between 20 and 45 years
3. Presence of bilateral multiple adjacent maxillary facial gingival recessions (2–3 mm) based on Cairo et al classification as RT1 and Miller’s Class I and II in the anterior or premolars.
4. Presence of identifiable cementoenamel junction (CEJ)
5. Patients with full mouth visible plaque score and Bleeding score of less than or equal o 20%
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of any systemic illness which hinder the healing of the surgical site.
2. Patients using medications that will interfere with the healing process or that contraindicate the surgical procedure.
3. Patients who received any surgical treatment during the previous 24 months on the selected sites.
4. Pregnant or lactating women.
5. Patients with smoking habit.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters such as gingival index and plaque index (as described by Loe and Silness), recession depth (RD), probing depth (PD), clinical attachment level (CAL), and width of keratinized tissue (WKT) will be measured. |
Baseline and 3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
16/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
| Gingival recession (GR) is described as an apical displacement of the gingival margin in relation to the cementoenamel junction, exposing the root surface to the oral cavity environment. The main indication to treat gingival recessions is to increase soft tissues thickness and stability to facilitate plaque control and prevent further periodontal inflammation and break-down or root caries. Coronally advanced flap (CAF), although a gold standard, is technique sensitive, and has limitations. A novel minimally invasive surgical approach The Pouch and Tunnel technique has been recently introduced for the management of isolated gingival recession and ensures mobilization of flap for graft coverage. Low-level laser therapy (LLLT) was first described in the literature by Mester et al. as a therapeutic method in several areas of medicine and dentistry. Recently, LLLT has also been used in the treatment of gingival recession. However, the basic mechanism by which LLLT may affect periodontal wound healing still remains unclear due to the lack of evidence. To our knowledge, studies evaluating LLLT associated with root coverage procedures using Pouch and Tunnel technique and subepithelial connective tissue graft are rare. Therefore, the aim of this study is to evaluate the clinical results of bilateral root coverage of GR associated with Subepithelial Connective Tissue Graft (SCTG) alone or combined with low-level laser therapy (SCTG + LLLT). | |