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CTRI Number  CTRI/2024/01/061147 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 02/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Root coverage using Zucchelli Technique and self-prepared Amnion-Chorion Membrane. 
Scientific Title of Study   Multiple gingival recession coverage using Amnion- Chorion Membrane prepared at Central Tissue Bank, MAIDS- 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  Supriya Jain 
Designation  Post graduate student  
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Periodontics Maulana Azad Institute of Dental Sciences Bahadur Shah Zafar Marg MAMC campus New Delhi

Central
DELHI
110002
India 
Phone  09818970282  
Fax    
Email  supriya89jain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Arundeep Kaur Lamba 
Designation  Professor and Head of Department  
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Periodontics Maulana Azad Institute of Dental Sciences Bahadur Shah Zafar Marg MAMC campus New Delhi

Central
DELHI
110002
India 
Phone  9654700980  
Fax    
Email  arundeep.kaur.lamba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Supriya Jain 
Designation  Post graduate student  
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Periodontics Maulana Azad Institute of Dental Sciences Bahadur Shah Zafar Marg MAMC campus New Delhi

Central
DELHI
110002
India 
Phone  09818970282  
Fax    
Email  supriya89jain@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Institue of Dental Sciences bahadur shah zafar marg MAMC campus new delhi 110002 
 
Primary Sponsor  
Name  Supriya Jain 
Address  Departement of Periodontics,Maulana Azad Institue of Dental Sciences, Bahadur Shah Zafar Marg, MAMC campus 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 Supriya Jain  Maulana Azad Institute of Dental Sciences  Department of Periodontics,Maulana Azad Institute of Dental SciencesBahadur Shah Zafar Marg, MAMC campus, New Delhi 110002
Central
DELHI 		 09818970282

supriya89jain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maulana Azad Institue of Dental Sciences  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  not applicable  not applicable 
Intervention  Root Coverage using Zucchelli technique along with Amnion-Chorion Membrane   Single Amnion-Chorion Membrane will be placed once over the recession defects and root surfaces after elevating the flap followed by suturing and patient will be followed up for 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Subjects with multiple (at least 3) Miller Class I and II recession-type defects
2. Subjects with a minimum width of keratinized gingiva ≥ 2mm
 
 
ExclusionCriteria 
Details  lactating women
smokers smoking more than 10 cigarettes per day
uncontrolled systemic disease
aggressive periodontitis
teeth with root caries, cervical abrasion
teeth with pulpal pain, periapical pathology or endodontically treated teeth
previous history of root coverage
adjacent edentulous space  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Mean root coverage achieved by using amnion-chorion membrane in Multiple Gingival
Recession.
2) Width and thickness of keratinized tissue achieved after treatment.
3) Esthetic satisfaction as patient-centered outcome post-treatment.
 		 baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical adverse effects of amnion chorion membrane if any.  3 and 6 months  
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   12/01/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [supriya89jain@gmail.com].

  6. For how long will this data be available start date provided 05-01-2024 and end date provided 05-09-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Subjects from outpatient Department of Periodontics will be screened. 15 subjects fulfilling inclusion criteria will be selected. Phase I therapy will be performed to attain baseline Plaque index Score <= 1. After 4 weeks all clinical parameters will be recorded. Zucchelli technique will be performed with the placement of amnion-chorion membrane at recession sites. Clinical parameters will be recorded again after 3 & 6 months.

 
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