| CTRI Number |
CTRI/2025/07/091141 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
“Evaluation of efficacy of 2 percent hayluronic acid gel and i-PRF in interdental papillary recession of maxillary anterior teeth – A RANDOMIZED CONTROL TRIAL” |
|
Scientific Title of Study
|
“COMPARATIVE EVALUATION OF EFFICACY OF 2 percent HYALURONIC ACID GEL AND INJECTABLE PLATELET RICH FIBRIN IN TREATMENT OF INTERDENTAL PAPILLARY RECESSION OF MAXILLARY ANTERIOR TEETH – A RANDOMIZED CONTROL TRIAL” |
| Trial Acronym |
Clinical Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Suyog C S |
| Designation |
BDS |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Sharavathi Dental College and Hospital
Shimoga
KARNATAKA
577204
India |
| Phone |
07892129866 |
| Fax |
|
| Email |
csdrsuyog@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shrinidhi M S |
| Designation |
MDS |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Sharavathi Dental College and Hospital
Shimoga
KARNATAKA
577204
India |
| Phone |
07892129866 |
| Fax |
|
| Email |
csdrsuyog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Suyog C S |
| Designation |
BDS |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
Sharavathi Dental College and Hospital
Shimoga
KARNATAKA
577204
India |
| Phone |
07892129866 |
| Fax |
|
| Email |
csdrsuyog@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrSuyog C S |
| Address |
"Rushba Nilaya" A-block, #-134 swami vivekanada badavane, gopala, shimoga, karnataka, India 577204 |
| 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 |
| Suyog C S |
Sharavathi Dental College and Hospital |
Sharavathi Dental College and Hospital, NH 206, Alkola, T.H Road, Shimoga, Karnataka - 577205
Department of periodontology
room no. 7
Shimoga
KARNATAKA |
7892129866
csdrsuyog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sharavathi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injectable-platelet rich fibrin |
The collected blood sample was then divided into two individual i-PRF tubes, each containing 10 ml of blood. These tubes should be devoid of any anticoagulant substances. The prepared i-PRF tubes are subjected to centrifugation at room temperature for a duration of 3 minutes. |
| Intervention |
scaling and root planing |
scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
1. Systemically healthy individuals of age groups ranging from 18 years to 40 years.
2. Patients with interdental papilla recession of class I and class II in the maxillary anterior teeth. (Norldand and Tarnow)
3. Patients with otherwise good periodontal health and oral hygiene with full mouth bleeding on probing index score less than 15%.
4. Patients with no interdental bone loss as seen in an IOPA x-ray.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone surgical periodontal therapy less than six months before the study.
2. Patients with malocclusion or midline diastema or aberrant frenal attachment or those undergoing active orthodontic therapy.
3. Smokers and tobacco chewers.
4. Patients taking drugs that cause gingival inflammation and enlargement.
5. Pregnancy and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| satisfactory papillary fill |
baseline, three months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
All the patients will undergo scaling and root planing and randomly alloted into 3 groups i.e, hayaluronic acid group, injectable-platelet rich fibrin group, control group. 2% hyaluronic acid is injected in the desired area and repeated on 21st, 42nd day. In the i-PRF group is injected on baseline and 11th, 22nd day. The control group only scaling and root planing is done |