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CTRI Number  CTRI/2024/02/062861 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 06/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing MTA, Emdogain and Human Biological Membrane As A Pulpotomy Agents in Permanent Teeth with Symptoms of Irreversible Pulpitis 
Scientific Title of Study   Comparative Evaluation Of MTA, Emdogain and Human Biological Membrane As a Pulpotomy Agents in Permanent Teeth With Irreversible Pulpitis: 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  Zoya Kidwai 
Designation  Junior Resident(Conservative Dentistry and Endodontics) 
Affiliation  Faculty Of Dental Sciences, King Georges Medical University, Lucknow 
Address  Department Of Conservative Dentistry and Endodontics, First Floor, Old Dental Building, Shahmina Road, Chowk, Lucknow, Uttar Pradesh, 226003, India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9453196059  
Fax    
Email  drzoyacpw10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Promila Verma  
Designation  Head Of The Department(Department Of Conservative Dentistry and Endodontics) 
Affiliation  Faculty Of Dental Sciences, King Georges Medical University, Lucknow 
Address  Department Of Conservative Dentistry and Endodontics, First Floor, Old Dental Building, Shahmina Road, Chowk, Lucknow, Uttar Pradesh, 226003, India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415542063  
Fax    
Email  promilarajesh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Zoya Kidwai 
Designation  Junior Resident(Conservative Dentistry and Endodontics) 
Affiliation  Faculty Of Dental Sciences, King Georges Medical University, Lucknow 
Address  Department Of Conservative Dentistry and Endodontics, First Floor, Old Dental Building, Shahmina Road, Chowk, Lucknow, Uttar Pradesh, 226003, India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9453196059  
Fax    
Email  drzoyacpw10@gmail.com  
 
Source of Monetary or Material Support  
Department Of Conservative Dentistry and Endodontics, Faculty Of Dental Sciences, King Georges Medical University, Lucknow 
 
Primary Sponsor  
Name  Zoya Kidwai 
Address  Department Of Conservative Dentistry and Endodontics, First Floor, Old Dental Building, Faculty Of Dental Sciences, King Georges Medical University, Lucknow 
Type of Sponsor  Other [Self Sponsored] 
 
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 Zoya Kidwai  KING GEORGES MEDICAL UNIVERSITY   Department Of Conservative Dentistry and Endodontics, Old Dental Building, Shahmeena Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH 
9453196059

drzoyacpw10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University, Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Permanent Teeth With Irreversible Pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP 1:MTA(Mineral Trioxide Aggregate) in Powder And Liquid Form by Safe Endo  After Performing Full Pulpotomy In Permanent Teeth With Irreversible Pulpitis, Manipulated MTA Will be placed in the Pulp Chamber followed by Temporary Restoration and next day Permanent Restoration will be done in Patients of Group 1 
Intervention  GROUP 2:Emdogain Gel by Straumann ,Basel, Switzerland and GROUP 3:Freeze-Dried Human Amniotic Membrane From Tissue Bank, Tata Memorial Hospital, Mumbai  After Performing Full Pulpotomy In Permanent Teeth With Irreversible Pulpitis, Emdogain Gel In Second group of patients and Human Amniotic Membrane in Third Group of patients will be placed In the Pulp Chamber After Random allocation In Respective Groups, Followed By Permanent Restoration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  I Clinical inclusion criteria:

1. Patients with in range of 18 to 45 years of age.
2. Patients presented with deep carious lesions including the first and second permanent molars.
3. No evidence of any clinical pathology · no mobility and had no tenderness to percussion.

II Radiographic inclusion criteria:

1. Pre-operative radiographs with no evidence of external or internal root resorption.
2. Absence of furcal radiolucency.
3. Absence of periapical radiolucency or widened periodontal ligament space
4. No more than one-third root resorption detected.

 
 
ExclusionCriteria 
Details  1. Patient with systemic diseases like diabetes mellitus, hypertension, hepatitis, human immunodeficiency virus, bone disorders, autoimmune disorders.
2. Patient with Periodontally compromised teeth.
3. Pregnant Females.
 
 
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 
To Check For Vitality Of the Tooth With No Clinical Signs Of Pain and Sensitivity After Using MTA, Emdogain Gel And Human Amniotic Membrane As A Pulpotomy Agents  At 1 month,3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To Check For Any Radiographical Signs Of Disease Progression like Periapical Lesion Formation Or Periodontal Widening After Using MTA, Emdogain Gel And Human Amniotic Membrane As A Pulpotomy Agent   At 1 month,3 months and 6 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Phase 4 
Date of First Enrollment (India)   25/02/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

It has long been assumed that permanent teeth with "irreversible pulpitis" have dental pulp that has been irreparably injured, is beyond repair, and requires root canal therapy.1The tooth’s survival time is dramatically shortened by this operation. Attempts have been made to use pulpotomy as a therapy strategy in permanent teeth with complete root development presenting symptoms of irreversible pulpitis, where radicular pulp is still healthy, in recognition of the intrinsic healing capacity of an infection-free pulp. The essential pulp should be preserved because it is crucial for induction, formation, nutrition, defence, and sensation in addition to other functions.

In order to treat teeth with pulpitis, pulpotomy, a minimally invasive and biologically based technique, has come back into use. It entails the removal of the coronal portion of the vital pulp in order to preserve the vitality of the remaining radicular region. Devitalization, preservation, and regeneration are the three categories under which pulpotomy can be categorized according to therapeutic goals. There has been a significant increase in interest in regenerative endodontics with the development of mineral trioxide aggregate (MTA).Current innovations include regeneration materials that are antimicrobial, biocompatible, and bioinductive that have been known to stimulate pulp cell regeneration, redirect the inflammatory response, and improve the healing capacity of the remaining healthy vital pulp. MTA is regarded as one of the most widely utilized calcium silicate cements used for this purpose on the basis of evidence demonstrating successful clinical outcomes.It has many benefits over other traditional endodontic materials, such as superior sealing ability, biocompatibility and the capacity to construct a dentin bridge in pulp capping and pulpotomy situations. 

Amelogenins, a class of proteins known to stimulate the growth and proliferation of periodontal ligament cells (PDL), are a major component of another regenerative material, enamel matrix derivative (EMD, Emdogain®), which has been supported for the regeneration of dental tissues

Human Biological Membrane is a novel material with substantial stem cell reserves, and they are now gaining prominence among regenerative materials. Its growth factors replicate the stem cell niche for ex vivo growth and offer a natural healing environment. Its natural characteristics include low immunological response, low toxicity, and the capacity to encourage cellular proliferation and attachment. In an era of minimally invasive dentistry, pulpotomy is now increasingly being considered for the management of teeth with irreversible pulpitis and is now being reinvestigated as a definitive treatment option for mature permanent teeth presented with irreversible pulpitis. Therefore, the focused question for this study is: Does using MTA, EMD and Human derived biological membrane in pulpotomy result in better clinical & radiographic outcomes.

 

Aims and OBJECTIVES

To compare and evaluate the use of MTA, Emdogain and Human biological membrane as pulpotomy agents in permanent teeth with irreversible pulpitis

MATERIAL 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.

Patient of age group 15 to 45 years with cariously exposed mature permanent teeth will be randomly allocated into 3 groups. Interventional pulpotomy using MTA, EMDOGAIN & HUMAN BIOLOGICAL MEMBRANE will be done in GRP1, 2 & 3 respectively. Clinical and radiographic evaluation will be done at 1 month, 3 months and 6 months.

Data obtained will be statistically analyzed. Any changes deemed in the interest of the study will

be done accordingly.


 
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