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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  
Nil 
 
Primary Sponsor  
Name  Self sponspored 
Address  H.P. Government Dental College and Hospital, Shimla 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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