| CTRI Number |
CTRI/2025/03/081738 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Gum Recession Treatments: Connective Tissue Grafts With and Without Injectable T-PRF |
|
Scientific Title of Study
|
A COMPARATIVE ASSESSMENT OF THE CLINICAL OUTCOME IN TREATING GINGIVAL RECESSION USING CONNECTIVE TISSUE GRAFT WITH OR WITHOUT INJECTABLE T PRF ALONG WITH CORONALLY ADVANCED FLAP A SPLIT MOUTH STUDY |
| Trial Acronym |
CTG, T-PRF, CAF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seelam Praveen Kumar |
| Designation |
Post Graduate |
| Affiliation |
Sree Sai Dental College And Research Institute |
| Address |
Sree Sai Dental College And Research Institute, Chapuram, Srikakulam.
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
7093958045 |
| Fax |
|
| Email |
spk37912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N Anwesh Reddy |
| Designation |
Associate Professor |
| Affiliation |
Sree Sai Dental College And Research Institute |
| Address |
Sree Sai Dental College And Research Institute, Chapuram Village, Patrunivalasa Post, Balaga Rural, Srikakulam.
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
7396469546 |
| Fax |
|
| Email |
anweshperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seelam Praveen Kumar |
| Designation |
Post Graduate |
| Affiliation |
Sree Sai Dental College And Research Institute |
| Address |
Sree Sai Dental College and Research Institute, Chapuram Village, Patrunivalasa Post, Balaga Rural, Srikakulam - 532401.
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
7093958045 |
| Fax |
|
| Email |
spk37912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Sai Dental College and Research Institute,Chapuram Village, Patrunivalasa Post, Balaga Rural, Srikakulam, Andhra Pradesh, India.
Pin Code: 532401 |
|
|
Primary Sponsor
|
| Name |
Seelam Praveen KUmar |
| Address |
Sree Sai Dental college and Research Institute, Chapuram, Srikakulam. |
| 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 |
| Seelam Praveen Kumar |
Sree Sai Dental College and Research Institute |
Department of Periodontology Sree Sai Dental College and Research Institute, Chapuram,Srikakulam.
Srikakulam
ANDHRA PRADESH |
7093958045
spk37912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENTS WITH GINGIVAL RECESSION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Connective graft along with injectable T PRF with coronally advanced flap |
A connective tissue graft combined with injectable titanium platelet-rich fibrin (T-PRF) and a coronally advanced flap is an advanced periodontal procedure used to treat gingival recession. This technique involves harvesting connective tissue from the palate and injecting T-PRF, which contains numerous growth factors that promote healing and tissue regeneration. The gingival tissue is then gently lifted and advanced toward the crown of the tooth, where it is secured in its new position to cover the graft. Total duration of the intervention is at Baseline, 3 months, 6 months. |
| Comparator Agent |
Connective tissue graft with coronally advanced flap |
A connective tissue graft with a coronally advanced flap is a periodontal procedure used to treat gingival recession. This technique involves harvesting a small piece of connective tissue from the palate and transplanting it to the affected site to cover the exposed root surface. The gingival tissue is then gently lifted and advanced toward the crown of the tooth, where it is secured in its new position to cover the graft. Total duration of the intervention is Baseline, 3 months, 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with no history of periodontal therapy or use of antibiotics in the preceding 6 months that could affect the tissue response and remodeling.
Age group: 18-40 years
Patients reported with similar bilateral or contralateral Millers Class 1 recessions at maxillary or mandibular incisors, canine with aesthetic compromise or dentinal hyper sensitivity.
Periodontal probing depths less than or equal to 2mm and areas of keratinized gingiva width greater than 2mm with no carious cervical lesions.
3mm or more of recession depths.
Absence of restoration in the area to be treated. |
|
| ExclusionCriteria |
| Details |
• Patients with known systemic disease
• Patients with aggressive periodontitis
• Use of tobacco in any form and alcoholism
• Immunocompromised patients, pregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coverage of recession increase in width of attached gingiva |
Base line, one month, three months, six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in Gingival Phenotype |
Base line, one month, three months, six months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2025 |
| 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
|
In this current split mouth study, a total number of 15 patients who will be visiting to the outpatient department of Periodontics will be selected for the present investigation through a careful selection process adhering to the inclusion and exclusion criteria, following the acquisition of informed consent. The quadrants will be categorized using flip coin method. The sites which will be treated with connective tissue graft alone will be considered as Group - I. Then sites which will be treated with connective tissue graft along with the injectable t-prf will be considered as Group - II. · Initially scaling and root planning will be done under local anesthesia followed by oral hygiene instructions. The patient will be recalled for periodontal surgery. · The following Clinical Parameters will be recorded at Baseline, one month, three months six months. a. Gingival bleeding index b. Plaque index c. Gingival recession depth d. Gingival recession width e. Clinical attachment level f. Keratinized tissue height · Connective tissue graft: We chose the harvesting site on the palate on the basis of the amount and quality of tissue and connective tissue graft was obtained by means of the De-epithelization of Free Gingival Graft. · Preparation t-prf: Intravenous blood was collected in two titanium tubes of 10ml without anticoagulant and centrifuged immediately at 700rpm for 3min at room temperature. The upper liquid layer was collected as injectable t-prf. |