| CTRI Number |
CTRI/2024/12/077534 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Coronally advanced flap with or without t-PRF for gingival recession |
|
Scientific Title of Study
|
Evaluation of coronally advanced flap with and without titanium prepared platelet rich fibrin for the treatment of maxillary anterior gingival recession defects: A comparative clinical study |
| 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 Karan Rastogi |
| Designation |
PG Resident |
| Affiliation |
Subharti Dental college and Hospital |
| Address |
Room no. 2
Department of Periodontology
Subharti dental college and hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9719250919 |
| Fax |
9528302676 |
| Email |
drkaranrastogi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Tomar sir |
| Designation |
Professor |
| Affiliation |
Subharti Dental college and Hospital |
| Address |
Room no. 2
Department of Periodontology
Subharti dental college and hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karan Rastogi |
| Designation |
PG Resident |
| Affiliation |
Subharti Dental college and Hospital |
| Address |
Room no. 2
Department of Periodontology
Subharti dental college and hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India
UTTAR PRADESH
250005
India |
| Phone |
9719250919 |
| Fax |
9528302676 |
| Email |
drkaranrastogi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 2
Department of Periodontology
Subharti Dental College and Hospital
Swami Vivekanand Subharti University
NH58 Delhi Haridwar Bypass Road Meerut
250005 Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr Karan Rastogi |
| Address |
Subharti dental college and hospital Delhi Haridwar Bypass Road NH 58 Meerut 250005 |
| 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 Karan Rastogi |
Subharti Dental college and hospital |
Room no. 2
Department of Periodontology
Subharti dental college and hospital, Swami Vivekanand Subharti University, NH 58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH |
9719250919
9528302676
drkaranrastogi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee |
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 |
| Intervention |
Group A
coronally advanced flap with T PRF |
Ten patients with Miller Class I and II gingival recession defects
Follow up for 3 months will be done |
| Comparator Agent |
Group B
Coronally advanced flap alone |
Ten patients with Miller Class I and II gingival recession defects
Follow up for 3 months will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients should be free of systemic disease.
Miller’s Class I and II gingival recession defects at the buccal aspect of maxillary incisors or canines.
No previous periodontal surgery at the affected teeth.
Evidence of patient’s ability to perform good plaque control
|
|
| ExclusionCriteria |
| Details |
Patient with history of any recent periodontal surgery in past 6 months.
Pregnant and lactating patients.
Smokers.
Recession defects associated with demineralization/caries, deep abrasion or restorations as well as teeth with evidence of pulpal pathology.
Un-cooperative patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| d) Recession length and recession width (in mm) measured by using UNC-15 periodontal probe and Vernier calliper |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (in mm) measured by using UNC-15 periodontal probe. |
Baseline 1 month and 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
TITLE- EVALUATION OF CORONALLY ADVANCED FLAP WITH T-PRF FOR THE TREATMENT OF MAXILLARY ANTERIOR GINGIVAL RECESSION DEFECTS: A CASE REPORT. INTRODUCTION: Gingival recession is apical displacement of soft tissue and can lead to esthetic concerns. Several treatment modalities have been proposed to treat gingival recession among which one modality is Coronally advanced flap (CAF). Platelet concentrates are biological products & T-PRF is a 3rd generation PRF which can be used as bioresorbable membrane enriched with platelets, growth factors, cytokines leading to enhancement of the final outcome. OBJECTIVE: Evaluation & assessment of Root Coverage in Miller class I gingival recession defect of maxillary anterior by using CAF with T-PRF membrane. METHODOLOGY: Patient will be selected and subjected to CAF with T-PRF. Evaluation will be done on the basis of percentage gain in root coverage, increase in width of keratinized gingiva and gain in CAL. The patients will be recalled for follow up after 1 and 3 months. RESULT: On 3 months, gain in CAL, increase in width of keratinized gingiva and gain in root coverage w.r.t 11 will be observed. CONCLUSION: CAF with T-PRF has shown good amount of root coverage & may proves to be an efficacious treatment modality.
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