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CTRI Number  CTRI/2025/09/095292 [Registered on: 23/09/2025] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Papilla Access Tunnel Technique for treatment of receding gums 
Scientific Title of Study   Evaluating Papilla Access Tunnel Technique with Platelet-Rich Fibrin and Amnion-Chorion Membrane for Management of Anterior Gingival Recessions: A Randomized Controlled Trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Shruti Singh 
Designation  Post Graduate Student 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Manipal College of Dental Sciences, Mangalore Department of periodontology room number four, Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9113912386  
Fax    
Email  shrutibps@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Neetha J Shetty 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of periodontology, room number four, Manipal College of Dental Sciences, Mangalore, Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880858025  
Fax    
Email  neetha.rajesh@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr. Shruti Singh 
Designation  Post Graduate Student 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Department of Periodontology, Room number Four, Manipal College of Dental Sciences, Mangalore, Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9113912386  
Fax    
Email  shrutibps@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Mangalore Affiliate of Manipal Academy of Higher Education , Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001 
 
Primary Sponsor  
Name  Dr Shruti Singh 
Address  Manipal College of Dental Sciences, Mangalore Affiliate of Manipal Academy of Higher Education, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001 
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 
Dr Shruti Singh  Manipal College of Dental Sciences, Mangalore  Department of Periodontology, Room number Four, Manipal College of Dental Sciences, Mangalore Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA 
9113912386

shrutibps@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 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amnion chorion membrane  Amnion Chorion Membrane which is a placental derived allograft is being used in papilla access tunnel technique Duration - 6 months 
Intervention  Platelet Rich Fibrin   Platelet rich fibrin which is a second generation platelet concentrate is being used in papilla access tunnel technique Duration - 6 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients presenting with Recession Type 1 RT1 Cairos classification of gingival
recession involving maxilla and mandibular anterior teeth.

Patients who have not undergone any previous root coverage procedures

Width of attached gingiva more than or equal to 2mm

Patients with normal hemogram report 
 
ExclusionCriteria 
Details  Patients with compromised systemic diseases

Pregnancy

Patients on antibiotic therapy for the past 6 months

Smokers

Patients with coagulation disorders

Patients with malaligned anteriors 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment    
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing Pocket Depth
Clinical attachment level
Complete root coverage
Mean root coverage
Recession depth
Width of keratinized tissue  
At baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Root Coverage Aesthetic Score
Patient Reported Outcome Measures 
At 6 months 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   06/10/2025 
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="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, also known as soft tissue recession, is defined as the displacement of
the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth or the platform
of a dental implant.This condition is associated with issues like dentine
hypersensitivity, non-carious cervical lesions (NCCLs), and compromised aesthetics.
Dealing with recession defects in the anterior region presents challenges due to various
anatomical factors, including the depth of the vestibule, position of the tooth, pull of
muscles and frenulum, and thickness of hard and soft tissues.
Several surgical techniques have been proposed over the years for treating mucogingival
defects in the aesthetic zone of the dentition. The Coronally Advanced Flap (CAF) along
with Subepithelial connective tissue graft (SCTG) is considered the gold standard for the
treatment of gingival recessions . Its advantages include a perfect color/contour match
with surrounding tissue and simplicity of execution.
The tunnel technique, introduced by Allen in 1994 , has evolved and the Papilla Access
tunnel technique, introduced by Edward P. Allen in 2019, is now suggested as a more
realistic option for gingival recession treatment in the anterior region. This technique
preserves papillary integrity and provides incision-free design, allowing improved surgical
access for site preparation and graft placement with reduced risk of perforation or injury to
thinner tissues
Intrasulcular approach for preparation of the tunnel site in Papilla Access tunnel technique
is accomplished easily when treating multiple tooth sites where a few of the teeth may
present with significant amount of recession by using the access provided by an elongated
sulcus associated with the recession defect. 
Regarding the use of membranes. Choukroun’s platelet-rich fibrin (PRF), a secondgeneration
platelet concentrate developed in 2001 (Choukroun et al,2001), is an autologous
leukocyte and platelet-rich fibrin biomaterial. PRF offers advantages such as simplified
and efficient preparation in a single-step centrifugation process, without the need for
anticoagulants or other gelling agents.
Recently, placental-derived tissues, known for their immune privileged composition,
antibacterial properties, and facilitation of cell migration, have gained popularity in
dentistry for guided tissue regeneration . Amnion membrane, an allogenic substitute
for subepithelial connective tissue graft, is particularly used for cost-effective root coverage
.The amnion contains stem cell reserves, growth factors, and proteins that accelerate
healing and regeneration, while the chorion is rich in collagen proteins. Based on these
biological properties, amnion and chorion membranes are theorized to be effective in
managing gingival recession and are being employed in root coverage procedures.
 
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