| CTRI Number |
CTRI/2020/09/028105 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the outcome of one step and two step mineral trioxide aggregate pulpotomy in irreversible pulp inflammation |
|
Scientific Title of Study
|
Evaluation of one versus two step technique on the outcome of mineral trioxide aggregate pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis – A prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amal Rana |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
7303806956 |
| Fax |
|
| Email |
amalrana2634@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amal Rana |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
Division of Conservative Dentistry and Endodontics, Center for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
7303806956 |
| Fax |
|
| Email |
amalrana2634@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Conservative Dentistry and Endodontics, Center of Dental Education and Research, All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Centre for Dental Education and Research |
| Address |
AIIIMS, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Amal Rana |
Centre for Dental Education and Research |
Department of Conservative Dentistry and Endodontics, Center for Dental Education and Research, AIIMS, New Delhi, South Delhi
South
DELHI |
7303806956
amalrana2634@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethic Committee for Post Graduate Research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One Step Mineral Trioxide Aggregate Pulpotomy |
In cases of symptomatic irreversible pulpitis, pulpotomy procedure will be performed. The coronal part of the pulp will be removed followed by the placement of Mineral Trioxide Aggregate biomaterial. Then a final restoration will be placed above it in the same visit. |
| Comparator Agent |
Two step Mineral Trioxide Aggregate pulpotomy. |
In cases of symptomatic irreversible pulpitis, pulpotomy procedure is performed. The coronal part of pulp is removed followed by the placement of Mineral Trioxide Aggregate biomaterial. Then a final restoration is placed above it after 24 hours in 2nd visit. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy patients of either gender between 15-35 years of age with mature mandibular 1st and 2nd molar with established clinical diagnosis of symptomatic irreversible pulpitis without periapical rarefaction.
2) Positive response to cold and electric pulp test.
3) Teeth with restorable carious lesion. |
|
| ExclusionCriteria |
| Details |
1) Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health.
2) Patients with systemic conditions which would compromise healing.
3) Patients not willing to participate in the study.
|
|
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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 |
1) To evaluate and compare the treatment outcoome of MTA pulpotomy used for the management of teeth with symptoatic irreverible pulpitis by :
a) One step Technique and
b) Two Step Technique |
T0 Preoperative IOPAR before starting the procedure.
T6 Post operative IOPAR approximately after 6 months.
T12 Post operative IOPAR after 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the functional and biological parameters of final restorations.
2) To evaluate the pulp vitality status after pulpotomy with electric and cold test. |
T0 Assessment of tooth by modified USPHS criteria and cold and Electric test before starting the procedure.
T6 Assessment of tooth by modified USPHS criteria and cold and electric pup test after 6 months.
T12 Assessment of tooth by modified USPHS criteria and Cold and electric test after 12 months. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Symptomatic irreversible pulpitis is an abnormal condition characterized by severe pain which lingers even after the removal of stimulus and is spontaneous. According to the older concept, pulp once inflamed gets affected in toto and treatment requires complete removal of diseased pulp tissue from root canal space. However, new concept refutes the older one and states that pulpal inflammation occurs by tissue compartment and even in the cases of irreversibly inflamed pulp, there are areas of uninflamed and disease free pulp tisuue. This has led to a paradigm shift in the treatment protocol from root canal treatment to pulp preservation by pulpotomy. MTA is currently the most preferred material for pulpotomy. But MTA have a long setting time. Hence, it is advised to place a final definitive restoration over MTA after 24 hours. This two-step MTA pulpotomy technique have certain disadvantages such as more time consuming, increased chances of possible iatrogenic errors,Inceased cost and increased chances of microleakage. However, current evidences from recent in-vitro studies suggests that glass ionomer cement can be placed over MTA in same visit without any adverse reaction between the two materials. Till this date there are no clinical studies in the literature that has compared one and two step technique for MTA pulpotomy. Hence, it is proposed to conduct a comparative study for the evaluating the outcome of MTA pulpotomy after one and two step technique. |