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CTRI Number  CTRI/2024/03/063506 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A simple tooth treatment for large caries in which only decayed part of tooth will be removed and healthy part will be preserved 
Scientific Title of Study   Evaluation of an alternate pulpotomy technique performed in carious permanent mature mandibular molar teeth with symptoms indicative of irreversible pulpitis: A randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ameer Faizal 
Designation  Junior Resident(Academic) 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Department of Conservative Dentistry and Endodontics 3rd floor ,Center for dental education and research AIIMS-New Delhi

New Delhi
DELHI
110029
India 
Phone  9562803194  
Fax    
Email  ameerfaizalpr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amrita Chawla 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Room no 309 Department of Conservative Dentistry and Endodontics 3rd floor ,Center for dental education and research AIIMS-New Delhi

New Delhi
DELHI
110029
India 
Phone  9871445522  
Fax    
Email  dr.amritachawla@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amrita Chawla 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Room no 309 Department of Conservative Dentistry and Endodontics 3rd floor ,Center for dental education and research AIIMS-New Delhi

New Delhi
DELHI
110029
India 
Phone  9871445522  
Fax    
Email  dr.amritachawla@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Center for Dental Education and research All India Institute of Medical Sciences New Delhi - 110029 
 
Primary Sponsor  
Name  Center for Dental Education and Research 
Address  Department of Conservative Dentistry and Endodontics Center for Dental Education and research All India Institute of Medical Sciences New Delhi - 110029  
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amrita Chawla  All India Institute of Medical Sciences  Room no 309 Additional Professor Department of conservative dentistry and endodontics Center for Dental Education and Research.
New Delhi
DELHI 
9871445522

dr.amritachawla@gmail.com 
DrAmeer Faizal  All India Institute of Medical Sciences  Department of conservative dentistry and endodontics Center for Dental Education and Research New Delhi
New Delhi
DELHI 
9562803194

ameerfaizalpr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alternative Pulpotomy technique  Tooth access opening will be done with high-speed bur under water coolant.Underneath the cariously exposed pulp horn, removal of the coronal pulp tissue of the tooth vertically down to the level of the affected canal orifice and application of a biomaterial directly onto the radicular pulp tissue.The procedure is done in 20-25 minutes. 
Comparator Agent  Full Pulpotomy  Tooth access opening will be done with high-speed bur under water coolant.Complete corornal pulp tissue will be removed and application of a biomaterial directly onto radicular pulp tissue.The procedure is done in 20-25 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Subjects of either gender belonging to 15-35 years of age group with proximal carious lesion on mandibular first and second molar tooth and symptoms suggestive of irreversible pulpitis.
Mandibular 1st and 2nd molar teeth with deep caries lesion penetrating ≥3/4 of the dentine thickness
Teeth with Positive response to EPT and cold test
Teeth with restorable carious lesions
 
 
ExclusionCriteria 
Details  Teeth with immature roots.
Teeth with central pit exposure .
Teeth with subgingival extension of proximal caries.
Teeth with cracks, cusp fractures, poor periodontal health

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical and radiographic outcome of
Alternate Pulpotomy Technique –Underneath the cariously exposed pulp horn, removal of the coronal pulp tissue vertically down to the level of the affected canal orifice, and application of a biomaterial directly onto the radicular pulp tissue (Midi-Pulpotomy) Full pulpotomy –Complete removal of the coronal pulp and application of a biomaterial directly onto the pulp tissue at the level of the root canal orifices.
 
Patients evaluated at baseline; after treatment
for 1 week; 3 month and followed up for 6
months and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the outcome of two techniques   3, 6 and 12 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3/ Phase 4 
Date of First Enrollment (India)   12/03/2024 
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  

Mature permanent teeth with symptomatic irreversible pulpitis have traditionally been managed with non-surgical endodontic therapy (NSET) . This was based on the concept that the entire pulp would degenerate in totality (strangulation theory) . However, with the enhanced understanding of pulp pathophysiology, this conception has changed. The current theory puts forward the concept that the pulpal inflammatory changes occur in stages with the inflammation occurring from coronal to radicular pulp denoting that vital pulp tissue can be expected in the radicular part of the teeth with irreversible pulpitis . Hence there has been a paradigm shift in the management of teeth with symptomatic irreversible pulpitis from NSET to pulpotomy. It has been performed widely with a high success rate. Pulpotomy procedure can be full or partial pulpotomy. According to European Society of Endodontics,  full pulpotomy is defined as complete removal of the coronal pulp and application of a biomaterial directly onto the pulp tissue at the level of the root canal orifices. The  average success rate of full pulpotomy is 95%. Whereas, partial pulpotomy is defined as the removal of the coronal 2-4 mm of pulp tissue after exposure, and application of a biomaterial directly onto the exposed pulp tissue.

Recent three randomized clinical trials (RCT) comparing success rate of partial pulpotomy with full pulpotomy have concluded an average success rate of 82% success rate for partial pulpotomy  . Systematic review and meta-analysis have reported 75% success rate of PP for cases with irreversible pulpitis(IP) . If unresponsive cases are considered as a failure, the overall success of partial pulpotomy after 1 year drops to 66%.Furthermore, in one of these RCTs more cases of PP as compared to CP had to be abandoned from the study due to uncontrolled bleeding ,this could be  attributed  to the fact that affected pulp may not have been completely eliminated in all cases as partial pulpotomy involves the removal of only superficial coronal tissue. Removal of inflamed tissue to the level of healthy uninflamed pulp is generally considered critical for healing, Perhaps insufficient removal of inflamed pulp tissue is to be blamed for the lower success rate of the partial pulpotomy technique. Additionally, partial pulpotomy may present technical difficulties when the pulp chamber space is extremely limited. Furthermore, arbitrary removal of 2-3 mm of pulp tissue is unclear to the clinician.

Due to this uncertainty in clinical approach and uncontrolled bleeding during  partial pulpotomy when performed, an alternate pulpotomy technique is proposed where ,underneath the cariously exposed pulp horn, removal of the coronal pulp tissue vertically down to the level of the affected canal orifice, and application of a biomaterial directly onto the radicular pulp tissue.(midi-pulpotomy).

In cases with IP, for removing inflammatory pulp tissue and managing haemorrhage, the midi-pulpotomy approach may have a better predictable outcome as extending the removal of the pulp tissue till the affected canal orifice may provide a cleaner incision and possibly minimal radicular pulp irritation. Technically it may provide the clinicians specific landmark or end point up to where the pulp tissue is amputated ruling out the arbitrary removal of pulp tissue thus giving specific direction.

Till date to the best of our knowledge there is no study cited in the literature which has attempted and evaluated the clinical and radiographic outcome of midi-pulpotomy technique in carious permanent mature mandibular molar teeth with symptoms indicative of irreversible pulpitis.

Thus, the aim of the present study is to evaluate and compare the outcome of an alternate pulpotomy technique (midi-pulpotomy) with Full Pulpotomy performed in carious mature permanent mandibular teeth with symptomatic irreversible pulpitis. The results of this study would provide a detailed and meticulous understanding of technical aspect of midi-pulpotomy procedure.

 
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