| CTRI Number |
CTRI/2025/04/085589 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Surgical approach for the treatment of single maxillary gingival recession with PRF and sticky bone using Coronally Advanced Flap |
|
Scientific Title of Study
|
Comparative evaluation of PRF and Sticky bone (PRF+FDBA) to treat single maxillary recession using coronally advanced flap |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeswar (deemed to be ) University |
| Address |
Room no 7 Department of Periodontology MMCDSR MULLANA AMBALA HARYANA
Ambala
HARYANA
133207
India |
| Phone |
08199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeswar (deemed to be ) University |
| Address |
Room no 7 Department of Periodontology MMCDSR MULLANA AMBALA HARYANA
Anugul
HARYANA
133207
India |
| Phone |
08199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeswar (deemed to be ) University |
| Address |
Room no 7 Department of Periodontology MMCDSR MULLANA AMBALA HARYANA
Anugul
HARYANA
133207
India |
| Phone |
08199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar College of Dental Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Dr Pratima Tripathy |
| Address |
Room no 7 Department Of Periodontology MMCDSR Mullana Ambala Haryana 133207 |
| 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 Pratima Tripathy |
Maharishi Markandeswar College Of Dental Sciences and Research |
Room no -7, Department of Periodontology, MMCDSR, Mullana, Ambala, Haryana
Ambala
HARYANA |
09583345100
ptripathy1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Mardandeswar Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with single maxillary recession |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sticky bone group |
Recession coverage in single maxillary recession using PRF and Sticky bone |
| Intervention |
PRF group |
Recession coverage in single maxillary recession using PRF |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age range-18-60 years
2. Prevalence of teeth with unilateral maxillary recession of gingival defects of Millers Class I and II
3. Co-operative and motivated patients committed to oral hygiene
4. Systemically healthy patients |
|
| ExclusionCriteria |
| Details |
1. Patient with systemic disease that could affect the process
2. Pregnant and lactating mothers
3. Patients with missing maxillary anterior teeth
4. Patients with a history of any periodontal surgery or orthodontics treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing recession depth and labial bone thickness in single maxillary recession using PRF and Sticky bone |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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)
|
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
|
The purpose of the study is to compare and evaluate the clinical and radiographic parameters in single maxillary recession by using PRF and Sticky bone at baseline, 3 months and 6 months using Coronally Advanced Flap. The null hypothesis was that there was no significant difference between PRF and Sticky bone. |