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CTRI Number  CTRI/2022/09/045303 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   To Evaluate Coronally Advanced Flap with Chorionic Membrane in Treatment of Isolated Gingival Recession: A Randomized Controlled Trail. 
Scientific Title of Study   Comparative Evaluation of Coronally Advanced Flap with and without Chorionic Membrane in the Treatment of Isolated Gingival Recession: A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geddam Navya 
Designation  Post Graduate 
Affiliation  Sri Venkateshwaraa Dental College 
Address  Sixth Floor Room Number 602 Department of Periodontology 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram main road Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  9390964123  
Fax    
Email  Geddamnavya1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Senthilnathan 
Designation  Professor and Head of the Department 
Affiliation  Sri Venkateshwaraa Dental College 
Address  Sixth Floor Room Number 602 Department of Periodontology 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram main road Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  9443133088  
Fax    
Email  principal@svdcpondy.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Geddam Navya 
Designation  Post Graduate 
Affiliation  Sri Venkateshwaraa Dental College 
Address  Sixth Floor Room Number 602 Department of Periodontology 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram main road Ariyur Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  9390964123  
Fax    
Email  Geddamnavya1@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Geddam Navya 
Address  Sixth Floor Room Number 602 Department of Periodontology 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram main road Ariyur Pondicherry 
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 Geddam Navya  Sri Venkateshwaraa Dental College  Sixth Floor Room Number 602 Department of Periodontology 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram main road Ariyur Pondicherry
Pondicherry
PONDICHERRY 
9390964123

geddamnavya1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (Human studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K05||Gingivitis and periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coronally Advanced Flap  Coronally Advanced Flap with Chorionic membrane- Test group Coronally Advanced Flap- Control group 
Intervention  Coronally Advanced Flap, Chorionic membrane  Coronally Advanced Flap with Chorionic membrane and Coronally Advanced Flap alone 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects who are diagnosed with Millers Class- I and Class-II gingival recession in anterior teeth and premolars,
Subjects aged between 18-45 years of both sexes,
Subjects who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  Participants who had undergone any mucogingival procedures at the selected sites within the previous 3 months,
Subjects with any known disease or intake of any medication that affects periodontal status,
Molar teeth and teeth with poor periodontal prognosis,
Subjects allergic to local anesthesia and chlorhexidine (CHX), antibiotic, and analgesic which would be prescribed,
Subjects with Aggressive periodontitis,
Current Smokers and Alcoholics,
Pregnant or Lactating females,
Subjects who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Recession height,
Recession width,
Clinical attachment loss,
width of keratinized gingiva  
At baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival tissue thickness, Complete root coverage and Mean root coverage.  At baseline 1 month and 6 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/09/2022 
Date of Study Completion (India) 02/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Gingival recession is the “apical migration of the gingival margin below the cemento-enamel junction (CEJ).” It is a multifactorial disease commonly caused by the accumulation of plaque biofilm resulting in inflammatory periodontal diseases and due to trauma caused by faulty and aggressive tooth brushing.  The coronally advanced flap (CAF) is a commonly used method for root coverage, and it has demonstrated very good results in treating gingival recessions regarding root coverage and esthetic outcomes. They possess antimicrobial and antibacterial properties and have shown to reduce inflammation and provide a protein-rich matrix, thereby facilitating the migration of cells at the defect area. Yadav K et al in 2015, concluded that, Chorionic membrane provides an effective alternative to autograft tissue in the treatment of shallow-to-moderate Miller’s Class I and II recession defects. In addition, the self adherent nature of the amniotic membrane significantly reduced surgical time and easier to perform. Chorion membrane has shown to reduce scar formation and inflammation, enhancing healing of the wound. Its matrix contains growth factors such as keratinocyte growth factor, basic fibroblast growth factor, and transforming growth factor-b, which help in regenerating the periodontium and gives a setting for faster healing.

 
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