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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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