| CTRI Number |
CTRI/2024/04/066468 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Pulp Sensibility Tests Responses in Type 2 Diabetes Mellitus Patients and Healthy Individuals in Indian sub population |
|
Scientific Title of Study
|
Comparison of pulp sensibility test responses in Type 2 Diabetes Mellitus patients and healthy individuals in Indian sub population: A 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 |
Dr ANNEYSHA BHATTCHARYYA |
| Designation |
MDS (Postgraduate student) |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
7338102112 |
| Fax |
|
| Email |
anneyshabhattacharyya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr ROHIT KOCHHAR |
| Designation |
HOD and Professor |
| Affiliation |
I.T.S. DENTAL COLLEGE, GREATER NOIDA |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9810034451 |
| Fax |
|
| Email |
hod.cons.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, 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 ANNEYSHA BHATTACHARYYA |
I.T.S DENTAL COLLEGE, GREATER NOIDA |
Room no.7, Department of Conservative dentistry and Endodontics, I.T.S. DENTAL COLLEGE, Greater Noida, 47, Knowledge parkn3, Greater Noida - 201308, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
7338102112
anneyshabhattacharyya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental college hospital and research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold test on Controlled type 2 diabetic patients |
This involves testing the response of dental pulp to cold stimuli on controlled type 2 diabetes mellitus patients. Patient will mark the response on numeric pain rating scale. The time interval between the cold application and patient response will be recorded. |
| Comparator Agent |
Cold test on Healthy individuals |
This involves testing the response of dental pulp to cold stimuli on Healthy individuals. Patient will mark the response on numeric pain rating scale. The time interval between the cold application and patient response will be recorded. |
| Intervention |
Cold test on Uncontrolled type 2 diabetic patients |
This involves testing the response of dental pulp to cold stimuli on uncontrolled type 2 diabetes mellitus patients. Patient will mark the response on numeric pain rating scale. The time interval between the cold application and patient response will be recorded. |
| Intervention |
Electric pulp test on Controlled type 2 diabetic patients. |
This involves testing the response of dental pulp to electric pulp test on controlled type 2 diabetes mellitus patients. The number indicating the pulp tester will be recorded as the patient response. |
| Comparator Agent |
Electric pulp test on Healthy individuals |
This involves testing the response of dental pulp to electric pulp test on Healthy individuals. The number indicating the pulp tester will be recorded as the patient response. |
| Intervention |
Electric pulp test on Uncontrolled type 2 diabetic patients. |
This involves testing the response of dental pulp to electric pulp test on uncontrolled type 2 diabetes mellitus patients. The number indicating the pulp tester will be recorded as the patient response. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-consenting to participate in the study.
- have at least 2 intact or minimally restored premolar teeth.
- with controlled type 2 diabetes mellitus.
- with uncontrolled type 2 diabetes mellitus (fasting plasma glucose levels more than 126mg/dl, random plasma glucose levels more than 200 mg/dl, HbA1c more than 7%)
-age and sex matched patients who report no history of diabetes and normal glucose tolerance. |
|
| ExclusionCriteria |
| Details |
1.Presence of any injury to head, neck and nervous system as well as other health conditions like cancer, pregnancy.
2.Patient taking drugs affecting CNS and anti inflammatory drugs.
3.History of trauma, severe periodontal disease, extensive caries or restoration, incompletely developed root, sclerosed canals, apical periodontitis, orthodontic brackets or recent history of orthodontic treatment, teeth that had root canal treatment and teeth with crowns |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the values of electric pulp test response in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.
To evaluate and compare the values of cold test response in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find a link between systemic disease like diabetes mellitus & the responses to pulp sensibility testing. |
at the end of the study duration which is 1 year 5 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
16/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Diabetes mellitus is the most common metabolic disorder that not only induces metabolic changes in the pulp but also influences both sensory and vascular structures. It has been shown that pulp sensibility tests may be influenced by systemic diseases. There is less information regarding the responses of type 2 diabetes patients to the pulp sensibility tests.Therefore, the need of the study to be done will help in improving the best intervention methods for diabetic patients and help clinicians to plan the specific treatment modality for a diabetic patient. The study will be done to evaluate and compare the response of the dental pulp to pulp sensibility tests (cold and electrical) in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.The forthcoming clinical study will be carried out within the Department of Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater Noida, Uttar Pradesh. The sample size for the study will encompass a total of 300 patients drawn from the Outpatient Department (O.P.D) of the Department of Conservative Dentistry and Endodontics, adhering meticulously to predefined inclusion and exclusion criteria. They will be divided into three groups:- Group A- 100 patients will be examined with controlled type 2 diabetes mellitus (patients who are on oral medication or insulin injections with fasting plasma glucose less than 126mg/dl, random plasma glucose less than 200mg/ dl, HbA1c less than 7%) Group B- 100 patients will be examined with uncontrolled type2 diabetes mellitus (Patients who have fasting plasma glucose levels more than 126mg/dl, random plasma glucose levels more than 200 mg/dl, HbA1c more than 7%) Group C- 100 patients, age and sex-matched patients with no history of diabetes and normal glucose tolerance will serve as control subjects. Electric pulp testing- Selected tooth to be tested will be dried and isolated with cotton rolls. A thin layer of toothpaste will be applied on buccal surface of the crown. An electric pulp tester probe will be placed on the sound coronal third of labial surface. Thereafter the patient will be asked to inform whenever he or she feels tingling pain or any sensation during activation of the electric pulp tester. The number indicating the pulp tester current will be recorded as the patient response. The sensibility tests will be performed with a 1-2 minute delay in order to minimise the effect of one test over the other. Cold test - the cold test will be performed with Endo frost. The tooth will be dried and isolated with cotton rolls. A cotton pellet will be sprayed and placed on the middle third of the crown of each tooth for 5 seconds or as soon as the patient raises his or her hand to indicate feeling either pain or a cold sensation. Each pellet will be sprayed no more than 2 times and then a fresh pellet will be used for the next tooth. Patients will mark the response on Numeric pain rating scale. The time interval between the cold application and patient response will also be recorded.
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