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CTRI Number  CTRI/2024/07/071007 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Tunneled coronally advanced flap in the treatment of receding gums 
Scientific Title of Study   Tunneled coronally advanced flap versus Modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession – A Randomized Controlled 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  Pragya Atray 
Designation  Postgradute 
Affiliation  Manipal College of Dental Sciences, Mangalore, Karnataka 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09759803280  
Fax    
Email  atray.pragya28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sangeeta U Nayak 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore, Karnataka 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880718372  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sangeeta U Nayak 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore, Karnataka 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880718372  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College Of Dental Sciences, Mangalore, karnataka pin- 575001, India 
 
Primary Sponsor  
Name  Pragya Atray 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Other [self] 
 
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 
Pragya Atray  Manipal College Of Dental Sciences, Mangalore  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore. Affiliated to Manipal Academy of Higher Education, Manipal
Dakshina Kannada
KARNATAKA 
9759803280

atray.pragya28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Manipal College of Dental Sciences, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Modified coronally advanced flap in combination with amnion membrane  Tunneled coronally advanced flap versus modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession 
Intervention  Tunneled coronally advanced flap in combination with amnion membrane   Tunneled coronally advanced flap versus modified coronally advanced flap in combination with amnion membrane for the treatment of multiple gingival recession 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with esthetic concern or hypersensitivity associated with GR,
2. Age ≥ 18 years, Systemically healthy and willing to sign consent form and agreeing to participate in the study
3. Presence of RT1 or RT2 multiple adjacent GRs,
4. At least 1.5 mm of keratinized tissue width (KTW) around the included teeth.
 
 
ExclusionCriteria 
Details  1. Subjects with an uncontrolled systemic disease (e.g., diabetes, etc.),
2. Smokers,
3. Presence of active periodontal disease,
4. Individuals taking medications, which could interfere with the healing of the soft tissues,
5. Known allergy to any of the biomaterials to be used.
6. Pregnant and lactating
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
recession depth
recession width
probing depth
gingival thickness
clinical attachment level
Keratinized tissue width
Mean Root Coverage
Complete Root Coverage
Root coverage esthetic score 
Baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
PROM Patient Reported Outcome Measures  3 and 6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   12/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/08/2024 
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    Gingival recession can arise from various predisposing and precipitating factors, as noted by Hall in 1984. Effective management of gingival recession involves not only eliminating these factors but also repositioning the gingiva to its original position. Numerous surgical methods have been developed, combining various grafting materials—such as autologous, allogenic, or xenogeneic—and surgical designs like flaps and tunneling procedures. The two most commonly used methods are the coronally advanced flap (CAF) and the tunnel technique (TUN). In 2022, Barootchi et al. introduced an innovative approach that combines CAF and TUN, termed the Tunneled Coronally Advanced Flap (TCAF). This technique, when combined with connective tissue graft (CTG), was suggested to be effective for treating isolated RT2 gingival recessions, potentially enhancing flap blood supply, graft vascularization, and patient-reported outcomes, along with clinical and aesthetic improvements.

Despite the advantages of connective tissue transplantation for gingival recession, the scarcity of grafts and the need for a secondary surgical site limit its utility. Consequently, guided tissue regeneration (GTR) using allograft membranes has been employed, showing promising results. Human placental membranes, like amnion and chorion, have been used successfully in medicine for healing burns and ulcerated skin disorders, owing to their unique biological properties that promote wound healing and may encourage regeneration. These membranes also have anti-adhesive effects, are bacteriostatic, provide wound protection, reduce pain, and aid epithelialization, making them suitable for GTR in dental applications. This study aimed to compare the efficacy of modified coronally advanced flaps (MCAF) and tunneled coronally advanced flaps (TCAF), both combined with amnion membrane, in treating gingival recessions.

A parallel-mouth randomized controlled trial was conducted with ten patients (five men and five women) aged between 38 and 45, presenting with 34 gingival recession defects. Participants were randomly assigned to either the test group (TCAF) or the control group (MCAF), each consisting of five patients. The test group underwent the tunneled coronally advanced flap procedure with an amnion membrane for treating RT1 and RT2 gingival recessions, while the control group underwent the modified coronally advanced flap technique with an amnion membrane for similar conditions. Inclusion criteria required patients to be 18 years or older, have esthetic concerns or hypersensitivity due to gingival recession, and be systemically healthy. Exclusion criteria included uncontrolled systemic diseases, smoking, active periodontal disease, medications affecting soft tissue healing, allergies to the biomaterials used, and pregnancy or lactation.

Patients received nonsurgical therapy, including scaling and root planing, followed by oral hygiene instructions. Clinical parameters such as probing depth (PPD), gingival recession width (GRW), width of keratinized tissue (WKT), and gingival tissue (GT) were measured at baseline and six months by a masked examiner. A "root coverage esthetic score" (RES) was used to evaluate aesthetic outcomes. For the surgical procedures, the control group underwent a split-full-split thickness flap without vertical releasing incisions, and the amnion membrane was placed over the root surfaces before advancing the flap coronally. The test group involved a vertical incision, creation of a split-full-split thickness flap, and tunneling to place the amnion membrane within the flap, secured with sutures.

Post-surgical care included prescribing antibiotics and using chlorhexidine mouthwash, with oral hygiene instructions and suture removal after 14 days. Clinical indicators were re-measured at three and six months, and patient satisfaction was assessed using the visual analogue scale (VAS) at baseline and six months. Statistical analysis, conducted using SPSS software, involved paired t-tests for intragroup comparisons and unpaired t-tests for intergroup comparisons.

 
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