| CTRI Number |
CTRI/2026/02/103306 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Materials to Improve Healing of Gum Bone Defects After Gum Surgery” |
|
Scientific Title of Study
|
Comparative Evaluation of Healing in Periodontal Suprabony Defects Following open flap debridement with enamel matrix derivative vs Hyaluronic Acid application- A 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 |
Rai Shikha Prabhunath |
| Designation |
PG Student |
| Affiliation |
Government dental college and hospital , Jamnagar |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
8155990711 |
| Fax |
|
| Email |
shikharai50606@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
Dean and Head of Department |
| Affiliation |
Government dental college and hospital , Jamnagar |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Patel |
| Designation |
Dean and Head of Department |
| Affiliation |
Government dental college and hospital , Jamnagar |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital , Jamnagar , navagam ghed , pathik ashram road , 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Shikha Rai |
| Address |
room no 6, periodontology department, Government dental college and hospital , Jamnagar , navagam ghed , pathik ashram road , 361008 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shikha Rai |
governement dental college and hospital , jamnagar |
room no 6 , periodontology department Government dental college and hospital , Jamnagar , navagam ghed , pathik ashram road , 361008
Jamnagar
GUJARAT |
08155990711
shikharai50606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MP Shah Medical College & Guru Gobind Singh Hospital Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Enamel Matrix Derivative |
After opening flap in suprabony defect enamel matrix derivative will be applied at root surface of tooth and then sutures will be taken |
| Intervention |
Hyaluronic Acid gel |
After opening flap in suprabony defect hyaluronic acid will be applied at root surface of tooth and then sutures will be taken |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stage III periodontitis
Grade A/ B
|
|
| ExclusionCriteria |
| Details |
Systemic Disease
Prolonged antibiotic usage
Prolonged Anti inflammatory drugs
Pregnant/ Lactating Females
Increased Tooth Mobility
Multirooted teeth with furcation involvement |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth
Gingival Recession
Clinical attachment level |
At baseline,3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Full mouth plaque score
Full mouth bleeding score |
At baseline,3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="1"
Months="6"
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
|
Patients with suprabony defects caused due to chronic periodontitis will be selected for the study. Randomization will be done and patients will be divided into 2 groups. Test group will be receiving Hyaluronic acid gel into suprabony defect while the control group will be receiving enamel marix derivative. The patients will be kept on follow up for a period of 6 months to evaluate pocket probing depth and clinical attachment level. |