| 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
|
|
|
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
|
|
|
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.
|
|
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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. |