| CTRI Number |
CTRI/2024/08/072430 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Accuracy of the heat test, cold test and electric test in finding the health status of the teeth after removing a portion of living tissue in the teeth - a microscopic study |
|
Scientific Title of Study
|
Diagnostic accuracy of thermal and electric pulp tests for pulp sensibility assessment after pulpotomy - a histomorphometric 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 |
Dr Pavithra R |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Conservative Dentistry and Endodontics, 3rd floor, Centre for dental education and research, All India Institute of Medical Sciences, New Delhi, Delhi 110029, India
New Delhi
DELHI
110029
India |
| Phone |
7305520682 |
| Fax |
|
| Email |
pavithrarathinaswamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 308, Department of Conservative Dentistry and Endodontics, 3rd floor, Centre for dental education and research, All India Institute of Medical Sciences, New Delhi, Delhi 110029, India
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra R |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Conservative Dentistry and Endodontics, 3rd floor, Centre for dental education and research, All India Institute of Medical Sciences, New Delhi, Delhi 110029, India
New Delhi
DELHI
110029
India |
| Phone |
7305520682 |
| Fax |
|
| Email |
pavithrarathinaswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, 3rd floor, Centre for Dental Education and Research, AIIMS, New Delhi, Delhi 110029, India. |
|
|
Primary Sponsor
|
| Name |
Centre for Dental Education and Research |
| Address |
Department of Conservative Dentistry and Endodontics, 3rd floor, Centre for Dental Education and Research, AIIMS, New Delhi, Delhi 110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pavithra R |
All India Institute of Medical Sciences |
Department of Conservative Dentistry and Endodontics 3rd floor Centre for dental education and research All India Institute of Medical Sciences New Delhi Delhi-110029
New Delhi
DELHI |
7305520682
pavithrarathinaswamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR NEW DELHI 110029 Room No 102 1st Floor Old O.T. Block Tel No 4579 (Internal) 26594579 (Direct) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulpotomy |
Removal of a part of pulp inside the tooth and replacing it with a calcium silicate based cement. The procedure is done in 15-20 minutes. |
| Comparator Agent |
Root canal treatment |
Removal of the entire pulp inside the tooth and replacing it with sealer and gutta percha material. The procedure is done in 45-60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Young patients with maxillary premolar teeth
indicated for extraction due to orthodontic
reasons and who are willing to volunteer for the
study will be included in the study.
2. Maxillary premolar teeth having occlusal
carious lesions with pulp exposure and
symptomatic irreversible pulpitis.
|
|
| ExclusionCriteria |
| Details |
1. Teeth having cracks, cusp fractures, carious
lesions with pulp necrosis or periapical lesion
and poor periodontal health.
2. Teeth which are not able to be isolated with
rubber dam.
3. Patients with systemic conditions which could
compromise the healing.
4. Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of the tooth response to cold test after partial and complete pulpotomy
procedure.
2. Assessment of the tooth response to heat test after partial and complete pulpotomy
procedure.
3. Assessment of the tooth response to electric pulp test after partial and complete
pulpotomy procedure.
4. Evaluation of the histological outcome of partial and complete pulpotomy.
5. Establishment of an association between response to pulp sensibility test and
histologic pulp status. |
Patients will be recalled after three months for evaluation of the outcome |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Determination of the appropriate site for cotton pellet placement for cold test in
teeth after partial and complete pulpotomy procedure.
2. Determination of the appropriate site for probe placement for heat test in teeth after
partial and complete pulpotomy procedure.
3. Determination of the appropriate site for electrode placement for electric pulp
sensibility test in teeth after partial and complete pulpotomy procedure.
|
Patients will be recalled after three months for evaluation of the outcome. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
07/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The pulpotomy procedure is based on the principles of minimal intervention dentistry and is aimed at the preservation of radicular pulp. It has been proposed as an alternative to root canal treatment for the management of carious exposed teeth. Based on the current outcome assessment criteria, the pulpotomy procedure is considered successful if the patient is asymptomatic and the radiograph reveals normal periapical architecture. This provides an indirect assessment of pulp survival after pulpotomy. Pulp sensibility tests, which stimulate the dental nerve fibers, are diagnostic aids for determining the status of pulp in routine clinical practice. It is assumed that the pulpotomized teeth do not respond to pulp sensibility tests due to the absence of coronal pulp tissue and the presence of heavy restoration in the pulp chamber. Therefore, the position statement by the European Society for Endodontology (ESE) does not include the use of a pulp sensibility test in the outcome assessment criteria. On the contrary, the findings of a retrospective study done at our department and limited published literature in peer-reviewed international journals suggests that the pulp sensibility tests can elicit a response in pulpotomized teeth and can be used as a tool to determine the pulp survival after pulpotomy procedure. However, every test, even with the highest level of precision, will misclassify a certain proportion of patients. Hence, it is important to determine the accuracy of a test to classify a patient’s response before it can be proposed as a tool for outcome assessment. To characterize the pulp sensibility test’s accuracy, histological examination is considered as the gold standard reference. Till date to the best of our knowledge, there is no study in the literature that compares the responses of pulp sensibility tests and the histological status of pulp after the pulpotomy procedure (partial or complete) in permanent teeth. Hence, the current study is planned with the primary goal of evaluating the diagnostic accuracy of pulp sensibility tests (thermal and electric pulp test) after partial and complete pulpotomy in permanent teeth. |