| CTRI Number |
CTRI/2025/04/085102 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two surgical techniques in the management of receding gums |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF THE CONVENTIONAL CORONALLY ADVANCED FLAP APPROACH VERSUS MINIMALLY INVASIVE APICAL TUNNEL SURGICAL APPROACH IN THE TREATMENT OF GINGIVAL RECESSION: A RANDOMIZED CONTROLLED 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 |
Surya A S |
| Designation |
Postgraduate |
| Affiliation |
J.K.K.Nataraja Dental College and Hospital, Namakkal |
| Address |
Department of Periodontics, J.K.K.Nataraja Dental College and Hospital, Kumarapalayam, Namakkal (dt).
Namakkal
TAMIL NADU
606601
India |
| Phone |
9677755531 |
| Fax |
|
| Email |
assurya.tvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sasi Kumar P K |
| Designation |
Professor |
| Affiliation |
J.K.K.Nataraja Dental College and Hospital, Namakkal. |
| Address |
Department of Periodontics, J.K.K.Nataraja Dental College and Hospital, Kumarapalayam, Namakkal (dt).
Namakkal
TAMIL NADU
638183
India |
| Phone |
9677755531 |
| Fax |
|
| Email |
sasikumar.pk@jkkn.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Surya A S |
| Designation |
Postgraduate |
| Affiliation |
J.K.K.Nataraja Dental College and Hospital, Namakkal |
| Address |
Department of Periodontics, J.K.K.Nataraja Dental College and Hospital, Kumarapalayam, Namakkal (dt).
Namakkal
TAMIL NADU
606601
India |
| Phone |
9677755531 |
| Fax |
|
| Email |
assurya.tvm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J.K.K.Nataraja Dental College and Hospital |
| Address |
J.K.K.N instituitions, Kumarapalayam, Namakkal (dt). Tamil Nadu. 638183 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Surya A S |
J.K.K.Nataraja Dental College and Hospital |
PG section,
Department of Periodontics.
Namakkal
TAMIL NADU |
9677755531
assurya.tvm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JKKN Institutional 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 |
Apical Tunnel Surgical technique (ATS) |
The Apical Tunnel Surgical (ATS) technique is a minimally invasive procedure used to treat gingival recession. It involves creating a small tunnel through the gingival tissue near the recession site, allowing the gingiva to be repositioned over the exposed root surface without the need for sutures or grafts. Platelet-Rich Fibrin (PRF) is applied to aid in tissue stabilization and healing. |
| Comparator Agent |
Coronally Advanced Flap technique (CAF) |
The Conventional Coronally Advanced Flap (CAF) technique is a well established gold standard surgical procedure used to treat gingival recession. It involves the creation of flaps in the gingival tissue, advancement of the flaps to cover the exposed root surface, and securing the flaps in place to promote healing and tissue regeneration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Cairo Recession Type 1 and Recession Type 2.
2. Patients having adequate width of keratinized tissue greater than or equal to 2mm.
3. Patients with willingness and ability to perform adequate oral hygiene.
4. systemically healthy individuals. |
|
| ExclusionCriteria |
| Details |
1. Patients with tooth mobility
2. Patients who received periodontal surgical therapy in last 6 months
3. Pregnant and lactating women.
4. Patients with systemic diseases and patients under systemic medications.
5. Individuals with a history of drug hypersensitivity.
6. Patient who engage in smoking and alcohol consumption.
7. Patients who demonstrate poor oral hygiene maintenance even after phase I therapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Root Coverage (MRC) at 3 months |
Mean Root Coverage (MRC) at Baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index, Recession Depth, Probing depth, Clinical Attachment level, width of Keratinized tissue. |
At baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
28/04/2025 |
| 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="3"
Days="10" |
|
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
|
Comparative Evaluation of the Conventional Coronally Advanced Flap versus Minimally Invasive Apical Tunnel Surgical Approach in the Treatment of Gingival Recession: A Randomized Controlled Clinical Study Objective:To compare the clinical outcomes of the conventional Coronally Advanced Flap (CAF) technique versus the minimally invasive Apical Tunnel Surgical (ATS) approach, both followed by the placement of Platelet Rich Fibrin (PRF), in the treatment of gingival recession. Study Design:Type: Single blinded, randomized controlled split mouth design. Participants: 11 individuals with 22 sites exhibiting gingival recession. Groups:
Inclusion Criteria:Patients with Cairo’s Recession Type 1 and Recession Type 2. Adequate width of keratinized tissue. Individuals aged from 18 years age to 60 years. Systemically healthy individuals. Willingness and ability to perform adequate oral hygiene.
Exclusion Criteria:Tooth mobility. History of periodontal surgical therapy in the last 6 months. Pregnant and lactating women. Systemic diseases or systemic medications. History of drug hypersensitivity. Smoking and alcohol consumption. Poor oral hygiene maintenance.
Methods:Preoperative Assessment: Clinical parameters measured include gingival index, recession depth, width of keratinized tissue, clinical attachment level, probing depth, and mean root coverage percentage. Surgical Procedures: CAF Technique: Involves creating flaps, treating the root surface, and placing PRF. ATS Technique: Involves creating a tunnel through an apical hole, repositioning the gingiva, and placing PRF.
Postoperative Care: Includes antibiotics, analgesics, and chlorhexidine mouthwash. Sutures are removed after 14 days.
Time Points for Data Collection:Baseline (Pre-Operative): Initial assessment of clinical parameters. 14 Days Post-Operative: Initial healing assessment. 3 Months Post-Operative: Final assessment of clinical parameters and outcomes.
Primary Outcome:Secondary Outcomes:Changes in gingival index. Changes in recession depth. Changes in width of keratinized tissue. Changes in clinical attachment level. Changes in probing depth.
Conclusion:The study aims to determine the efficacy of two surgical techniques (CAF and ATS) in treating gingival recession, focusing on root coverage and other clinical parameters. The results will provide valuable insights into the effectiveness and safety of these techniques in periodontal plastic surgery. |