| CTRI Number |
CTRI/2025/11/097758 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of 0.2 percent Hyaluronic acid as an adjunct to coronally advanced flap in the management of RT1 Gingival Recession |
|
Scientific Title of Study
|
Management of RT1 gingival recession defects with and without 0.2 percent Hyaluronic acid as an adjunct to coronally advanced flap: 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 |
UJJWAL KUMAR GUPTA |
| Designation |
Junior Resident |
| Affiliation |
H.P. Government Dental College and Hospital, Shimla |
| Address |
ROOM NO. 204, DEPARTMENT OF PERIODONTOLOGY, H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL
Shimla HIMACHAL PRADESH 171001 India |
| Phone |
8789910193 |
| Fax |
|
| Email |
guptau992@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. KANWARJIT SINGH ASI |
| Designation |
PROFESSOR & HEAD |
| Affiliation |
H.P. Government Dental College and Hospital, Shimla |
| Address |
ROOM NO. 202, DEPARTMENT OF PERIODONTOLOGY, H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL
Shimla HIMACHAL PRADESH 171001 India |
| Phone |
|
| Fax |
|
| Email |
kanwarjitsinghasi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
UJJWAL KUMAR GUPTA |
| Designation |
Junior Resident |
| Affiliation |
H.P. Government Dental College and Hospital, Shimla |
| Address |
ROOM NO. 204, DEPARTMENT OF PERIODONTOLOGY, H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL
Shimla HIMACHAL PRADESH 171001 India |
| Phone |
8789910193 |
| Fax |
|
| Email |
guptau992@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self sponspored |
| Address |
H.P. Government Dental College and Hospital, Shimla |
| Type of Sponsor |
Other [] |
|
|
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 |
| UJJWAL KUMAR GUPTA |
H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PERIODONTOLOGY, Room no.204, H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL, SHIMLA Shimla HIMACHAL PRADESH |
8789910193
guptau992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE, H.P. GOVERNMENT DENTAL COLLEGE AND HOSPITAL SHIMLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally Advanced Flap alone |
In this, RT1 gingival recession on other side will be treated with Coronally advanced flap only |
| Intervention |
Coronally Advanced Flap with 0.2 percent Hyaluronic Acid |
In this, RT1 gingival recession on one side will be treated with Coronally advanced flap along with application of 0.2 percent Hyaluronic Acid |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patient with no co-morbidities.
2. Patients with a buccal recession on both sides of maxillary or mandibular arch with RT1 or Miller’s ClassI or Class II gingival recession defects.
3. Presence of a clearly identifiable CEJ and with at least 1mm of keratinized tissue apical to the recession.
4. Full mouth plaque score and Full mouth bleeding score less than 20percent.
5. History of no systemic antibiotics in the last 6 months.
6. No history of mucogingival or periodontal surgery at the experimental site. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females.
2. Patients with active periodontal disease.
3. Teeth with prosthetic crown or restoration with the cervical edge in the cervical area
4. Patients with presence of occlusal interferences such as mispositioned or rotated tooth.
5. Subjects with hematological disorders, immunocompromised and any other systemic illnesses.
6. History of chronic alcoholism.
7. History of smoking or use of smokeless tobacco.
8. Previous history of gingival recession surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Mean % root coverage, Keratinised Tissue width, Gingival Tissue Thickness |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
03/12/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
AIM- To assess and compare treatment outcomes of coronally advanced flap with and without Gengigel (0.2% Hyaluronic Acid) for RT1 gingival recession defects. Objectives- The objectives of this study are: 1. To compare the percentage of root coverage at baseline and at the end of treatment for CAF alone. 2. To compare the percentage of root coverage at baseline and at the end of treatment for CAF with Gengigel. To compare the clinical parameters (CAL/PPD/KTW/MRC) of test and control.Patients satisfying inclusion and exclusion criteria will be randomly assigned into two groups by simple randomization method: - Group A (control group) – Coronally Advanced Flap Group B (test group) – Coronally Advanced Flap with application of 0.2% hyaluronic acid All the recruited patients will be asked to sign an informed consent prior to the treatment. All the patients will be examined at baseline(T0) for probing pocket depth [PPD], clinical attachment level [CAL], recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival tissue thickness (GTT). After initial periodontal examination at baseline, all the participants will undergo initial phase of treatment of thorough scaling and root planning . The surgical area will be prepared with adequate anesthesia using 2% lignocaine HCL containing 1:1,00,000 epinephrine. After local anesthesia and before the elevation of the flap, both the exposed root surfaces will be gently planned with a sharp Gracey no. 1–2 curettes to reduce root convexity. Immediately after, the root surface will be washed for 60 s with water spray. Intrasulcular incisions will be then made with a blade (no. 15) on the buccal aspect of the involved tooth. This incision will be horizontally extended to the adjacent papillae avoiding the gingival margin of the adjacent teeth. Two oblique releasing incisions will be carried out from the mesial, and distal extremities of the horizontal incision beyond the mucogingival junction. A trapezoidal full-thickness flap will be raised with a periosteal elevator, until the mucogingival junction. Then a partial-thickness dissection will be carried out apically leaving the underlying periosteum in place. In addition, a mesiodistal and apical dissection parallel to the vestibular lining mucosa will be performed with a blade to release residual muscle tension and to facilitate the passive coronal displacement of the flap. The papillae adjacent to the involved tooth will be de-epithelized. The flap then advanced coronally and adapted to cover the cementoenamel junction In the experimental group, hyaluronan gel (gengigel 0.2%) applied on the root surface using a sterile instrument prior to flap advancement and suturing whereas in the control group the flap will be advanced coronally without application of HA gel. Suturing of oblique releasing incisions will be performed with absorbable 5-0 braided coated Polygalactin 910 (Vicryl) sutures, while the coronal mesial and distal extremities of the flap will be secured by two single sutures placed in the interdental areas. Immediately following surgery, use of ice packs was recommended for 3 h. All patients were instructed to discontinue tooth brushing, avoid trauma around the surgical site. In the event of pain, the use of ibuprofen + paracetamol (thrice daily) was recommended. A 0.2% chlorhexidine digluconate solution rinse was prescribed 2 times (60 s) daily for the first 10 days. The sutures were removed after 7 days. The patients were instructed to clean the surgical sites with a cotton pellet soaked in a 0.2% chlorhexidine digluconate solution twice daily for 10 days. Assessment of all the study groups will be done as: T0 =Periodontal examination with all the clinical parameters will be done at the baseline T1= at 3months. T2 = at 6 months. On each visit, the area will be checked for meticulous plaque control. |