FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074880 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial comparing the changes in width and thickness of gums following increase in depth of gums with and without using indigenously prepared Amnion-Chorion Membrane. 
Scientific Title of Study   Comparison of changes in gingival phenotype following vestibuloplasty with and without using indigenously prepared Amnion-Chorion Membrane – A 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  Dr Chanda Yadav 
Designation  Post graduate student 
Affiliation  Maulana Azad Institute Of Dental Sciences 
Address  Department of Periodontics and Oral Implantology, Maulana Azad Institute Of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  8287215142  
Fax    
Email  chandayadav0112@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Farrukh Faraz 
Designation  Professor (SAG) 
Affiliation  Maulana Azad Institute Of Dental Sciences 
Address  Department of Periodontics and Oral Implantology, Maulana Azad Institute Of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  9654700981  
Fax    
Email  farrukhfaraz@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Chanda Yadav 
Designation  Post graduate student 
Affiliation  Maulana Azad Institute Of Dental Sciences 
Address  Department of Periodontics and Oral Implantology, Maulana Azad Institute Of Dental Sciences, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  8287215142  
Fax    
Email  chandayadav0112@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Institute of Dental Sciences,New Delhi, Miradard Marg, Bahadur Shah Zafar Marg, LNJP Colony, 110002 
 
Primary Sponsor  
Name  Dr Chanda Yadav 
Address  Department of Periodontics, Maulana Azad Institute Of Dental Sciences, Bahadur shah zafar marg, New Delhi 110002 
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 Chanda Yadav  Maulana Azad Institute Of Dental Sciences  Room no 601, 6th floor, Department of Periodontics and Oral Implantology
Central
DELHI 		 8287215142

chandayadav0112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Maulana Azad Institute of Dental Sciences New Delhi(Govt. of NCT of Delhi)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Only Vestibuloplasty will be done   No Amnion Chorion Membrane will be used. 
Intervention  Amnion-chorion membrane  Vestibuloplasty will be done and amnion-chorion membrane will be placed at surgical site. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients of either sex between the age group
18 to 55 years.
2. Subject with less than or equals to 2mm width of attached gingiva
in mandibular anterior region.
3. subject having positive tension test.
4. subject having shallow vestibule.
5. Non smokers.  
 
ExclusionCriteria 
Details  1.No intake of medication affecting periodontal status of tooth.

2.Alcohol and drug abusers.

3.Uncontrolled systemic diseases (e.g uncontrolled diabetes, uncontrolled hypertension, bleeding disorders).
4.Pregnant or lactating woman. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in width of keratinized tissue
2. Change in thickness of keratinized tissue 		 At baseline, 1 month and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in clinical attachment level  At baseline, 1 month and 6 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   N/A 
Date of First Enrollment (India)   19/10/2024 
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   This study is a randomized, single blinded, parallel group, control trial comparing the changes in gingival phenotype following vestibuloplasty with and without indigenously prepared  Amnion-Chorion membrane in subjects having attached gingiva less than or equal to 2mm and shallow vestibule in mandibular anterior region that will be conducted in Maulana Azad Institute of Dental Sciences, New Delhi in India. The primary outcome measure will be changes in width and thickness of keratinized tissue at baseline, 1 month and 6 months. The secondary outcome measure will be changes in clinical attachment level at baseline, 1  month and 6 months. 
Close