| CTRI Number |
CTRI/2026/02/103037 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Gingival recession management using hyaluronic acid gel with or without prf membrane in pinhole surgical technique |
|
Scientific Title of Study
|
MANAGEMENT OF ISOLATED GINGIVAL RECESSIONS USING HYALURONIC ACID GEL WITH OR WITHOUT PLATLET RICH FIBRIN(PRF)MEMBRANE IN PINHOLE SURGICAL TECHNIQUE- A RANDOMIZED CLINICAL TRAIL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keerthi V |
| Designation |
Post graduate student |
| Affiliation |
The oxford Dental College |
| Address |
Department of Periodontology, Room no. 3, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
7760840412 |
| Fax |
|
| Email |
keerthivenkatesh04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savitha A N |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room no. 3, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9845203336 |
| Fax |
|
| Email |
Sunaina1096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savitha A N |
| Designation |
Professor |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Periodontology, Room no. 3, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9845203336 |
| Fax |
|
| Email |
Sunaina1096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Room no. 3, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068 |
|
|
Primary Sponsor
|
| Name |
Dr Keerthi V |
| Address |
Department of Periodontology, Room no. 3, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Keerthi V |
The Oxford Dental College |
Room no3, Department of Periodontology, The Oxford Dental College, 10th Milestone, Bommanahalli, Hosur Road, Bengaluru-560068.
Bangalore
KARNATAKA |
7760840412
keerthivenkatesh04@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 |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PST with HA gel |
After administration of local anesthesia, a small entry point will be created below the mucogingival junction and intrasulcular incisions will be made. A full-thickness tunnel will be elevated to allow coronal mobilization of the gingivopapillary unit. Hyaluronic acid gel will be injected using a blunt cannula. The gingival margin will be coronally advanced to cover the exposed root surface and stabilized using suspensory sutures anchored to composite stops and periodontal dressing will be applied. 6months follow up. |
| Intervention |
PST with HA gel and PRF membrane |
After administration of local anesthesia, a small entry point will be created below the mucogingival junction and intrasulcular incisions will be made. A full-thickness tunnel will be elevated to allow coronal mobilization of the gingivopapillary unit. A prepared PRF membrane will be inserted into the tunnel, followed by injection of hyaluronic acid gel using a blunt cannula. The gingival margin will be coronally advanced to cover the exposed root surface and stabilized using suspensory sutures anchored to composite stops and periodontal dressing will be applied. 6months follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who consent to participate in the study.
2. Presence of at least 20 teeth.
3. Miller Class I and II gingival recession with greater than or equal to 2mm depth.
4. Presence of identifiable CEJ and adequate width of keratinized tissue apical to recession.
5. Adequate plaque control.
6. No clinical signs of active periodontal disease or inflammation at the treatment site. |
|
| ExclusionCriteria |
| Details |
1 Patients with relevant systemic condition or disease and, on drug therapy.
2 Patients with presence of occlusal interferences such as malposition or rotated teeth.
3 Habitual smokers and tobacco chewers.
4 Patients with a history of previous mucogingival or periodontal surgery at the experimental site in last 6 months.
5 Presence of gingival recession with caries, restoration or with pulpal pathology.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of HA gel with or without PRF membrane along with pinhole surgical technique in root coverage for Miller’s class I&II gingival recession. |
Baseline, 3 days, 7 days, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of HA gel with or without PRF membrane along with pinhole surgical technique in root coverage for Miller’s class I&II gingival recession.
2. To evaluate the long-term stability of the outcomes of PST over 3&6 months post operative follow-up periods. |
Baseline, 3 days, 7 days, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
23/02/2026 |
| 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="0"
Months="10"
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 is a common periodontal condition that necessitates
effective therapeutic interventions .Conventional
methods in use have associated donor site complications that has led
to the pinhole surgical technique
(PST), which holds promise as a
minimally invasive, predictable method
for obtaining optimal patient-based outcomes. PST when paired with regenerative materials like platelet rich fibrin (PRF),enamel matrix
derivatives, hyaluronic acid, etc it inherently promotes
tissue regeneration.
Hyaluronic
acid (HA)is a potent anti-inflammatory agent and modulates wound healing due to
its ability to scavenge the inflammatory cells. Platelet rich fibrin(PRF) derived from the patient’s
own blood, is a safe, and cost-effective biomaterial that enhances treatment outcomes by releasing growth factors that support wound
healing, angiogenesis, and tissue regeneration, making it a proven adjunct in the treatment of gingival
recession.
Due
to limited evidence regarding the use of HA gel with PRF membrane in PST for
isolated gingival recessions, this study aims
to compare the efficacy of HA gel, with or without PRF membranes using pinhole
surgical technique in treating Miller’s Class I and II gingival recessions. |