| CTRI Number |
CTRI/2025/01/079357 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of pulp status of permanent mature teeth using thermal tests, electric pulp test and modified pulse oximeter |
|
Scientific Title of Study
|
Thermal tests, electric pulp test and use of modified pulse oximeter for assessment of pulpal status of permanent mature teeth: an in vivo 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 Anirban Pandit |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics 2nd floor
Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati
Kolkata
WEST BENGAL
700114
India
Kolkata WEST BENGAL 700114 India |
| Phone |
7047073329 |
| Fax |
|
| Email |
dranirbanpandit468@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Paromita Mazumdar |
| Designation |
Head of the Department |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics 2nd floor
Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati
Kolkata
WEST BENGAL
700114
India
Kolkata WEST BENGAL 700114 India |
| Phone |
9831029606 |
| Fax |
|
| Email |
head_cons.gnidsr@jisgroup.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Anirban Pandit |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics 2nd floor
Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati
Kolkata
WEST BENGAL
700114
India
Kolkata WEST BENGAL 700114 India |
| Phone |
7047073329 |
| Fax |
|
| Email |
dranirbanpandit468@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics 2nd floor Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati Kolkata
Kolkata
WEST BENGAL
700114
India |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics 2nd floor Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati Kolkata
Kolkata
WEST BENGAL
700114
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 Anirban Pandit |
Guru Nanak Institute of Dental Sciences and Research |
Department of Conservative Dentistry and Endodontics 2nd floor
Guru Nanak Institute of Dental Sciences and Research 157/F
Nilgunj Road Sahid Colony Panihati
Kolkata
WEST BENGAL
700114
India Kolkata WEST BENGAL |
07047073329
dranirbanpandit468@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Thermal tests |
includes heat and cold test. In heat test a warm heated gutta purcha stick will be applied on labial/buccal surface of tooth and patient response will be noted in all the three groups-positive control, negative control and symptomatic irreversible pulpitis tooth for 15 seconds interval for each test and total time for 5 minuits |
| Comparator Agent |
Electric pulp test |
here the electrical probe will be touched over the labial/ buccal surface of crown of the tooth and current will be increased progressively and patients response will be noted in all the three groups for 15 seconds for each tooth and total time of 5 minuits. |
| Intervention |
Modified pulse oximeter test |
here the pulse oximeter probe with modified probe holder will be held at buccal/labial and lingual/ palatal surfaces of crown of teeth and recordings noted at monitor, here the pO2 will be noted for all the teeth group for 15 seconds each tooth and total time for 5 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to the category 1 of American Society of Anesthesiologists (ASA)
2.Individuals belonging to the age range of 18-60 years of either sex.
3.Patients diagnosed with having at least one healthy, one clinically diagnosed as symptomatic-irreversible pulpitis and one complete root canal treated tooth without any full or partial coverage restoration among his/her maxillary central incisor, maxillary and, or mandibular 1st molar.
4.The positive control tooth should be caries free having healthy periodontium with pocket depth less than 3 mm measured using a Williams probe based on clinical as well as radiographic findings.
5.The root canal treated tooth should be free of any kind of partial or full coverage prosthesis and should only have a permanent/ temporary core build up present and should be well obturated with root filling with 2mm short of the apex and without any periapical radiolucency.
|
|
| ExclusionCriteria |
| Details |
Thermal tests: includes heat and cold test. In heat test a warm heated gutta purcha stick will be applied on labial/buccal surface of tooth and patient response will be noted in all the three groups-positive control, negative control and symptomatic irreversible pulpitis tooth. 2. Electrical pulp testing: here the electrical probe will be touched over the labial/ buccal surface of crown of the tooth and current will be increased progressively and patients response will be noted in all the three groups. 3. Modified pulse oximeter test- here the pulse oximeter probe with modified probe holder will be held at buccal/labial and lingual/ palatal surfaces of crown of teeth and recordings noted at monitor, here the pO2 will be noted for all the teeth group. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 5. Comparison of sensitivity, specificity and diagnostic accuracy among heat test, cold test, electric pulp test and modified pulse oximeter test in assessment of vitality status of pulp in permanent mature healthy teeth as positive control group, RCT treated teeth without full coverage crowns as negative control group and teeth with symptomatic irreversible pulpitis as test group at baseline |
evaluation of the pulp status will be done at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sensitivity, specificity, positive predictive value & accuracy of modified pulse oximeter |
evaluation will be done immediately |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/02/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="1" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The assessment of pulp vitality is a crucial diagnostic procedure in the practice of dentistry, and for treating traumatized teeth. Assessment of the teeth vitality is complicated by the fact that the dental pulp is enclosed within calcified tissues. Traditionally, the dentist has related on testing methods designed to reproduce symptoms associated with pulpal pathosis. The methods include thermal stimulation , electrical stimulation, anaesthetic testing or direct dentin stimulation . These modalities fall short of the ideal pulp tests on several criteria. All these testing methods have the potential to produce an unpleasant and occasionally painful sensation, and eventually obtaining inaccurate results by a drip of ice on to adjacent teeth or gingival tissues, or when electric current applied to the tooth surface is conducted in the periodontal ligament, thus stimulating periodontal nerve fibers. False negative responses may also occur in the cases of calcific metamorphosis, in the teeth with immature root formation, or subsequent to an impact injury . All these are subjective tests that depend upon patients perceived response to a stimulus as well as the interpretation of that response. Another problem with these traditional pulp testing methods is that they only indirectly monitor pulp vitality by measuring the neural responses and not circulation. An ideal pulp test must be -simple, objective, standard, reproducible, reliable, painless and low-con. These traditional tests are pulp sensitivity tests. However, the main limitations of these tests are that they assess the neural response of pulp while the main indicator of pulp vitality is its blood supply. Moreover, efficacy of these tests depends on the presence of adequate number of mature neurons in the pulp tissue. A direct measure of the blood circulation of pulp is the only real measure of the pulp vitality. The pulse oximeter is a non-invasive oxygen saturation monitoring device widely use in medical practice for recording blood O2 saturation levels during the administration of general anesthesia. Recently, few studies were done using pulse oximetry to detect the 02 saturation of the pulp. Based on these pioneering studies, the present original work was undertaken to compare the clinical effectiveness of the pulse oximeter over the conventional techniques of cold test and electric pulp tester. But no such pulse oximeter is available in market for dental use only and these conventional pulse oximeters has some drawbacks like they measured the vitality of teeth only accessible areas of oral cavity and operator cannot hold the light emitting and light absorbing probe proper and steadily at the surface of tooth. To overcome these limitations probe holder was modified by using 3D printer machine. The material was PGA- poly glycolic acid polymer. Modified pulse oximeter probe holder was allowed for holding the probe parallel to each other, firmly and securely. |