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CTRI Number  CTRI/2025/11/097852 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Application of stem cells in dental field 
Scientific Title of Study   Clinical outcome of apexification procedure using amniotic membrane matrix and mineral trioxide aggregate barrier 
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 Roma M 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Dakshina Kannada
KARNATAKA
575001
India 
Phone  09902338318  
Fax    
Email  roma.m@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Roma M 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Dakshina Kannada
KARNATAKA
575001
India 
Phone  09902338318  
Fax    
Email  roma.m@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Roma M 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences Mangalore 
Address  Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences Mangalore Light House Hill road
Dakshina Kannada
KARNATAKA
575001
India 
Phone  09902338318  
Fax    
Email  roma.m@manipal.edu  
 
Source of Monetary or Material Support  
Amniotic membrane  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Homi Babha Building, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
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 Roma M  Manipal College of Dental Sciences Mangalore  Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences Mangalore, Light House Hill road Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences Mangalore, Light House Hill road
Dakshina Kannada
KARNATAKA 		 09902338318

roma.m@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K042||Pulp degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amniotic membrane  A bur (carbide fissure) fitted on a handpiece with low speed was used to eliminate all cavities while rubber dam isolation and local anaesthesia were in place. Access cavities were prepared and refined with Endo-Z bur (Dentsply Maillefer, Tusla, OK, USA). Three percent sodium hypochlorite (Vishal Dentocare Pvt Ltd, India) was used to copiously irrigate the pulp space. With endodontic K files (Dentsply Inc, Maillefer, Dentsply India) the working length was measured radiographically and positioned at 1 mm short of matching root apex. Cleaning, shaping and biomechanical debridement was achieved with hand K files and Protaper hand files up to size F3 (Dentsply Inc, Maillefer, Dentsply India). The treated pulp spaces were copiously irrigated with 3% sodium hypochlorite. The completed pulp spaces with sterile absorbent points were dried and subjected to intrancanal medication using non setting calcium hydroxide paste (CALCICURE,Voco) over a course of 2 weeks and provisionally sealed with intermediate restorative material (Cavit G, 3M ESPE GmbH, Neuss, Germany).  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals with immature anterior permanent teeth with AAE consensus of Pulp necrosis with/without symptomatic chronic apical periodontitis were recruited  
 
ExclusionCriteria 
Details  Subjects who were deemed recalcitrant, had grossly decayed teeth, or with systemic disorders that affected their overall immunological condition were not allowed to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Creation of calcific bridge for apical seal closure at baseline, 4 weeks and 8 weeks  Creation of calcific bridge for apical seal closure at baseline, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   02/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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   All ten cases treated with apexification procedure with amniotic membrane and Biodentin were prospectively followed over a period of 1 years  revealed signs of recovery with development of apical calcific bridge formation, healing of periapical lesions and absence of clinical symptoms.  
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