| 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
|
|
|
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
|
|
|
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. |