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CTRI Number  CTRI/2024/01/061104 [Registered on: 04/01/2024] 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   To measure the clinical increase in alveolar ridge width after augmentation with self-prepared FDBA block graft and amnion chorion membrane 
Scientific Title of Study   To Evaluate the Clinical Outcomes of Horizontal (Lateral) Alveolar Ridge Augmentation Using Indigenously Prepared FDBA Block Graft and Amnion Chorion Membrane. 
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. Bhawana  
Designation  Post Graduate Student 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Periodontic Maulana Azad Institute of Dental Sciences, MAMC Campus Bahadur Shah Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone  9654740468  
Fax    
Email  bhawanaoriya19@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 MAMC Campus Bahdur Shah Zafar Marg New Delhi

Central
DELHI
110002
India 
Phone  9654700980  
Fax    
Email  arundeep.kaur.lamba@gmail.com  
 
Details of Contact Person
Public Query  
Name  bhawana oriya 
Designation  post graduate stuudent 
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Department of Periodontics Maulana Azad Institute of Dental Sciences MAMC campus bahadur shah zafar marg new delhi

Central
DELHI
110002
India 
Phone  9654740468  
Fax    
Email  bhawanaoriya19@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Institute of Dental Sciences  
 
Primary Sponsor  
Name  Bhawana 
Address  Department of Periodontics Maulana Azad Institute of Dental Sciences MAMC Bahadur shah Zafar Marg New Delhi 
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 BHAWANA  Maulana Azad Institute of Dental Sciences   Department of Periodontics Maulana Azad Institute of Dental Sciences MAMC campus bahadur shah zafar marg new delhi
Central
DELHI 		 9654740468

bhawanaoriya19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Maulana Azad Institute of Dental Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alveolar Ridge Augmentation using FDBA block graft and Amnion-Chorion membrane  Alveolar Ridge Augmentation will be done using Indigenously prepared FDBA block graft secured with titanium screw over the edentulous alveolar ridge on lateral aspect and covered by Amnion-Chorion membrane followed by suturing and after 6 months followed by dental implant placement. 
Comparator Agent  Not applicable   Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Subjects with ridge defect with ridge width(RW) less than 4mm which was insufficient for standard implant placement.

Presence of maxillary or mandibular single or multiple (maximum 3 teeth loss) horizontal ridge defects.
Absence of any sign of pathology at the proposed surgical sites.  
 
ExclusionCriteria 
Details  Native Bone with any sign of pathology such as inflammation, or pus discharge.
Subjects with bone disease (Paget’s disease, rickets, osteoporosis, arthritis, multiple myeloma etc.) and Radiographic evidence of bone tumour (benign ormalignant) or any cyst.
Uncontrolled systemic diseases (uncontrolled diabetes, uncontrolled hypertension), taking immunosuppressive anticoagulant medications and pregnancy.
Subjects under longterm bisphosphonate therapy.
smokers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To evaluate the change in horizontal alveolar ridge width using FDBA block graft with Amnion-chorion membrane in deficient alveolar ridges.
 		 baseline and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical adverse effects of FDBA block graft and ACM, if any.  baseline and after 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)   15/01/2024 
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)   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 - 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 [bhawanaoriya19@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 will be screened from the outpatient Department of Periodontics, Maulana Azad Institute of Dental Sciences, New Delhi

Subjects who fulfill the inclusion criteria will be recruited for the study.

Phase 1 therapy, which includes scaling and root planing, will be done.

After 4 weeks of Phase 1 therapy, all clinical parameters were recorded ( Plaque index, gingival Index , alveolar ridge width at crest and 5mm apical to crest)

Horizontal ridge augmentation will be performed using an FDBA block graft fixed with titanium screws and Amnion chorion membrane

After 6 months, Phase II surgery will be performed, and all clinical parameters will be recorded again, followed by dental implant placement. Following that, statistical analysis will be carried out. 



 
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