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CTRI Number  CTRI/2024/12/077649 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
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 Study Comparing Two Modern Treatments Amniotic Membranes and PlateletRich Fibrin to Support the Healing and Growth of Young Permanent Teeth 
Scientific Title of Study   comparative evaluation of human amniotic membrane and platelet-rich fibrin (prf) for apexogenesis in immature non vital permanent teeth: a randomized controlled 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  Sharanya A J 
Designation  Junior resident 
Affiliation  KING GEORGES MEDICAL UNVERSITY 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY CHOWK
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FACULTY OF DENTAL SCIENCES
Lucknow
UTTAR PRADESH
226003
India 
Phone  8147662400  
Fax    
Email  sharanyajayachandra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Promila verma  
Designation  Pofessor and Head 
Affiliation  KING GEORGES MEDICAL UNIVERSITY 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS , chowk
FACULTY OF DENTAL SCIENCES
Lucknow
UTTAR PRADESH
226003
India 
Phone  9415542063  
Fax    
Email  promilarajesh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rhythm Bains 
Designation  Professor 
Affiliation  KING GEORGES MEDICAL UNIVERSITY 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY
FACULTY OF DENTAL SCIENCES
Lucknow
UTTAR PRADESH
226003
India 
Phone  9935033439  
Fax    
Email  docrhythm77@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, King Georges Medical University,Lucknow,226003,Uttar Pradesh,India 
 
Primary Sponsor  
Name  FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY , CHOWK 226018 
Type of Sponsor  Government medical college 
 
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 
Sharanya A J  Faculty of Dental Sciences, King Georges Medical University  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY
Lucknow
UTTAR PRADESH 
8147662400

sharanyajayachandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics committee , king georges medical university u.p.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K009||Disorder of tooth development, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Human Amniotic Membrane  During Apexogenesis procedure , after disinfection of canal , Human Amniotic membrane provided by the Tata Memorial Hospital,Parel, Mumbai is filled inside the canal upto middle thirds , and sealed with MTA  
Comparator Agent  platelet rich fibrin  during apexogeneis procedure after disinfecting cacal the canal space upto middle third is filled with platelet rich fibrin,which is made from the 1oml of patients own blood using centrifuge machine at 3000rpm for 10 mins 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Healthy patient under the age of 25 years with permanent
immature non-vital teeth will be included in the study. 
 
ExclusionCriteria 
Details  Patients above 25 years
Deciduous teeth
Permanent immature teeth that can be treated by a conventional root
canal
treatment/apexifification
Known or suspected current malignancy
History of other metabolic bone diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The clinical outcome will be assessed by checking for symptoms like pain, swelling, or sensitivity, and radiographic outcomes will measure changes in root length and apex width  3 , 6 , 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Apical width with regeneration of pulp tissue  12 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   20/01/2025 
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="0"
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  

Pulp tissue in an immature open-apex tooth has a rich blood supply and contains stem cells that possess a great potential to regenerate in response to damage. Pulp necrosis of an immature tooth as a result of caries or trauma could arrest further development of the root, leaving the tooth with thin and weak walls that are prone to fracture. Endodontic treatment of such a tooth is difficult because thin walls do not allow much instrumentation, and the obturation might not provide predictable apical seal due to the large opening of the apex.

Regenerative endodontics is a novel modality which involves physiological replacement of the damaged structures of tooth like dentin, root and cells of the pulp-dentin complex. These procedures have not only shown to resolve apical periodontitis but continued root development, thus increasing the thickness and strength of the previously thin and fracture-prone roots.

Biological membranes have emerged as a promising tool for regenerative endodontics. These membranes are made of biocompatible materials that can create a barrier or scaffold that supports tissue regeneration and growth. Recently researched tissue engineering materials like platelet-rich fibrin (PRF), platelet-rich plasma (PRP), collagen, give promising results in regenerative endodontics.One such biologically/naturally derived tissue is the Human amniotic membrane (HAM) which has been utilized in the medical field since 1900. The presence of collagen, elastin, laminin and fibronectin makes this membrane an excellent scaffold in tissue engineering. HAM is biologically active due to the presence of growth factors (GF) that aids cell migration and facilitates wound healing.HAM in endodontic procedures, such as pulp capping and periapical surgery, have shown encouraging results.

Considering the regenerative potential of HAM, this study has been designed with the aim to evaluate the efficacy of Amniotic membrane as scaffold for regenerative endodontics will be compared to PRF regarding percentage change in apical width and root length.

AIMS AND OBJECTIVES:

To assess the clinical and radiographic outcomes when using human Amniotic membrane for apexogenesis in immature nonvital permanent teeth.

To compare the efficacy of human Amniotic membrane as scaffold in apexogenesis of immature nonvital permanent teeth as compared to PRF


MATERIALS AND METHODS:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow, in collaboration with Department of Paediatric and preventive Dentistry, Faculty of Dental Science, King George’s Medical University, Lucknow.

The study will be conducted only after getting clearance from the Institutional Ethical Committee and registration in CTRI.

Suitable subjects will be selected from the department of Conservative Dentistry & Endodontics and Paediatric & Preventive Dentistry and will be randomly divided into two groups namely Platelet-rich fibrin group and human Amniotic Membrane group. This study includes a structured approach to evaluate the clinical and radiographic outcomes of the treatment and compare with baseline parameters over a specified follow-up period. The trial aims to assess the efficacy and safety of the procedure and the use of the amniotic membrane as a scaffold material in dental regenerative therapy.

The data obtained will be statistically analyzed. Any changes deemed in the interest of the study will be done accordingly.

 
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