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CTRI Number  CTRI/2024/05/067558 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which technique is better for treatment of loose gums  
Scientific Title of Study   Comparative evaluation of efficacy of tunneled coronally advanced flap versus coronally advanced flap with collagen matrix for management of isolated gingival recession: A randomized clinical 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  Col T Prasanth 
Designation  Head of Department, Department of Periodontology 
Affiliation  Army Dental Centre R R 
Address  Room No 1A, First floor, Department of Periodontology, Army Dental Centre Army Hospital Research and Referral, Dhaula Kuan, New Delhi

South
DELHI
110010
India 
Phone  8284851155  
Fax    
Email  tprasanthavin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Col T Prasanth 
Designation  Head of Department, Department of Periodontology 
Affiliation  Army Dental Centre R R 
Address  Room No 1A, First floor, Department of Periodontology, Army Dental Centre Army Hospital Research and Referral, Dhaula Kuan, New Delhi

South
DELHI
110010
India 
Phone  8284851155  
Fax    
Email  tprasanthavin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Col T Prasanth 
Designation  Head of Department, Department of Periodontology 
Affiliation  Army Dental Centre R R 
Address  Room No 1A, First floor, Department of Periodontology, Army Dental Centre Army Hospital Research and Referral, Dhaula Kuan, New Delhi

South
DELHI
110010
India 
Phone  8284851155  
Fax    
Email  tprasanthavin@gmail.com  
 
Source of Monetary or Material Support  
Department fund Room No 1A, First floor, Department of Periodontology, Army Dental Centre, Army Hospital Research and Referral, Dhaula Kuan, New Delhi, India, PIN code - 110010) 
 
Primary Sponsor  
Name  Army Dental Centre RR 
Address  Department fund Room No 1A, First floor, Department of Periodontology, Army Dental Centre, Army Hospital Research and Referral, Dhaula Kuan, New Delhi, India, PIN code - 110010) 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Virender Singh  Army Dental Centre, Army Hospital, Research and Referral  Room No 1A, First floor, Department of Periodontology, Army Dental Centre, Army Hospital Research and Referral, Dhaula Kuan, New Delhi, India, PIN code - 110010)
South
DELHI 		 9690494547

drvirender.nain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Dental Centre (Research and Referral), Delhi Cantt Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CORONALLY ADVANCED FLAP WITH COLLAGEN MATRIX  The steps for the surgical intervention for the control group after initial preparation of the patient and obtaining the adequate anesthesia will be as followed: 8. The internal bevel incision will be made from gingival margin to the bottom of the sulcus with two vertical incisions extending beyond the mucogingival junction and then the mucoperiosteal flap will be reflected using a sharp dissection. The root surface will then be scaled and planed. After placing and stabilizing the adequate sized Collagen Matrix (CM) graft the flap will be sutured at a level coronal to the pretreatment position. Postoperative instructions and medications will be same as above.  
Intervention  TUNNELED CORONALLY ADVANCED FLAP WITH COLLAGEN MATRIX  The steps for the surgical intervention Tunneled Coronally Advanced Flap (TCAF) for the test group will be as followed: 1. The Tunneled Coronally Advanced Flap (TCAF) for isolated Recession Type 1 Gingival recession (RT 1 GR) will be involving the elevation of one trapezoidal surgical papilla and the execution of only one vertical incision, The level of the horizontal incision to create the trapezoidal surgical papilla will be based on the recommendation for conventional Coronally Advanced Flap and will be performed at a distance equal to the recession (REC) plus 1 mm apical to the papilla tip. 2. A Bard Parker blade No 15c will be utilized to execute the intrasulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved. Indeed, for achieving a tension-free flap advancement, at least one adjacent tooth to recession defect (not on the site adjacent to the vertical incision) also will be tunneled. The midfacial aspect of the affected tooth will be elevated with tunneling knives, while the surgical papilla will be incised and elevated in a split-thickness manner with a blade No 15c. 3. The flap will then be elevated from the area in which the surgical papilla and the vertical incision were performed, and the procedure will be continued by introducing curved tunneling knives from the sulcus of the tooth with the intact papilla. 4. The anatomical papilla will then be deepithelialized, either with a blade or microsurgical scissors while the other surgical papilla will be gently detached from the interproximal bone and mobilized with a Periosteal elevator Molt No 9 instrument. 5. After mechanical and chemical root conditioning with 24% ethylenediaminetetraacetic acid (EDTA) for 2 min, and rinsing with sterile saline, a Collagen Matrix (CM) graft will be inserted underneath the flap and moved below the non-incised papilla. The graft will then be sutured to the deepithelialized anatomical papilla and to the periosteum with a simple interrupted sutures and/or sling sutures around the tooth. 6. The flap will then be coronally advanced and sutured using sling sutures and suspended sutures around the splint contact point. The vertical incision will then be approximated to the adjacent soft tissue with simple interrupted sutures. 7. Oral and written postoperative instructions will be provided to patients and will be including Ibuprofen (600 mg) every 4 to 6 hrs as needed, Amoxicillin (500 mg) 3 times daily for 7 days, and chlorhexidine mouth rinse (0.12%) twice daily for 2 weeks, and the recommendation of gentle warm saltwater rinses. Sutures will be removed at 1 week post-operatively and the patients will receive further instructions regarding the type of toothbrush and brushing technique.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  a) Patients aged between 20 - 40 years.
b) Patients with isolated Cairo’s RT1 GR located on anteriors and premolar teeth.
c) Patients with ASA 1 physical status classification.
d) No surgical periodontal therapy in last 2 years at the involved site
e) Teeth having clinically identifiable CEJ
 
 
ExclusionCriteria 
Details  a) Teeth having root caries / non-carious cervical lesions (NCCL) or previous restoration.
b) Past or current tobacco users (both smoking and chewing tobacco).
c) Pregnant/Expecting/Lactating women.
d) Full mouth bleeding score (FMBS) & Full mouth plaque score (FMPS) ≥ 10% after completion of Phase I therapy.
e) Patients with a history of known allergy to xenogenic biomaterials.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in gingival recession height  At 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in gingival recession width  At 3 months and 6 months 
Increase in width of keratinized gingiva  At 3 months and 6 months 
Gain in clinical attachment level  At 3 months and 6 months 
Modified gingival bleeding index  At 3 months and 6 months 
Complete root coverage   At 3 months and 6 months 
Mean root coverage  At 3 months and 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   27/05/2024 
Date of Study Completion (India) 02/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/07/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  

 

 

Gingival recession (GR) is defined as the exposure of the root surface due to apical migration of junctional epithelium apical to the cementoenamel junction (CEJ). GR is usually associated with dentinal hypersensitivity, susceptibility to root caries, and aesthetic concern. Therefore, obtaining root coverage (RC) becomes an integral part in the treatment of GR. Hence, the goal of root coverage is to restore the gingival structure functionally and esthetically.

Several surgical treatment modalities, such as free gingival autograft, free connective tissue autograft, pedicle autografts, laterally positioned pedicle flap, coronally advanced flap (CAF), subepithelial connective graft, guided tissue regeneration and pouch and tunnel technique have been used for gingival recession treatment.

Coronally advanced flap (CAF) with connective tissue graft (CTG) remains the gold standard till date. One of the recent technique is Tunneled coronally advanced flap (TCAF) which minimizes incisions and reflection of flaps and provide abundant blood supply and intimate contact of the donor tissue with the recipient site.

The efficacy of the tunnel technique with a CTG from the tuberosity for the treatment of multiple gingival recession has been investigated. The rationale behind using TCAF relies on the fact that the Tunnel technique can detach the buccal papillae from the interproximal bone, allowing for a coronal repositioning of the midfacial soft tissues.

Several soft tissue substitutes have been utilized as alternatives to CTG to avoid increased post-operative morbidity due to second surgical site. Collagen matrix (CM) was employed to treat recession deformities without the discomfort of second surgical sites, as was the case with CTGs. CM possesses hemostatic qualities, biocompatible and function as a scaffold for fibroblasts and promote tissue remodeling. When combined with tissue augmentation techniques, the CM has demonstrated the ability to increase the width of keratinized tissue surrounding teeth.

Gain in the root coverage is an advantage of the CAF at the papilla without attachment loss and tunneling minimizes the incisions and flap reflection thereby providing abundant blood supply to the tissues and intimate contact with recipient site. Therefore to take advantage of both coronally advanced flap and tunneling simultaneously, TCAF was introduced. TCAF is a recent novel technique and has not been compared with coronally advanced flap (the gold standard technique).

The aim of this study is to compare the effectiveness of tunneled coronally advanced flap (TCAF) versus coronally advanced flap (CAF) with collagen matrix (CM) for the management of isolated Cairo’s recession type 1 gingival recession. 

 
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