FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077028 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of Diabetics on pulp sensibility test after prescribing analgesics. 
Scientific Title of Study   Effects of Non-Steroidal anti- inflammatory drugs on pulp sensibility test on diabetic patients with symptomatic irreversible pulpitis - A Double Blinded Randomized 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  Rajeswari SV 
Designation  Post Graduate student 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics , Meenakshi ammal Dental college and Hospital, Alapakkam main road, Maduravoyal, Chennai

Chennai
TAMIL NADU
600095
India 
Phone  9444638057  
Fax    
Email  rajisiva1711@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandini S 
Designation  Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital. 
Address  Room No 10, Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai

Chennai
TAMIL NADU
600095
India 
Phone  9884292850  
Fax    
Email  nandini_80@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N Velmurugan 
Designation  Head of the Department, Dept of Cons and Endo 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai

Chennai
TAMIL NADU
600095
India 
Phone  9840164167  
Fax    
Email  velu9911@gmail.com  
 
Source of Monetary or Material Support  
Self Funded, Conducted at OPD of Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Chennai 
 
Primary Sponsor  
Name  Dr Rajeswari. SV 
Address  Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095 
Type of Sponsor  Other [Self funded] 
 
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 Nandini S  Meenakshi Ammal Dental College and Hospital  Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Alapakkam, Maduravoyal, Chennai - 600095
Chennai
TAMIL NADU 
9884292850

nandini_80@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Meenakshi Ammal dental college and Hospital.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ketorol DT 10 mg  Ketorol DT 10 mg to be administered pre emptively once before the start of the pulp sensibility testing. 
Comparator Agent  Placebo Tablet - Folic Acid 5 mg   Folic acid 5 mg to be administered pre emptively only once before the start of the pulp sensibility testing 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Symptomatic irreversible pulpitis with VAS more than 85 mm on the 100 mm pain scale
Type 2 Diabetics with HbA1c less than or equal to 6.5
Normal Patients with SIP and VAS more than 85 mm on the 100 mm pain scale 
 
ExclusionCriteria 
Details  Other systemic diseases
Pregnancy and lactation
NSAIDs intake 12 hours prior to testing
Pulp Stones and other abnormalities
Abscesses
Patient on other drugs like corticosteroids
Non consenting patients
Drug Allergies 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pulp Sensibility Test and Responsiveness of Dental Pulp  20 min 40 min and 60 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Age and Gender with logistic regression on the pulp sensibility of diabetic patients  20 min 40 min and 60 mins 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   01/12/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 a chronic inherited or acquired disorder caused by low production or ineffectiveness of insulin produced by the pancreas glands. Diabetes is a metabolic disease that is induced because of hyperglycemia. Hyperglycemia may result from either impairment of secretion or malfunction of insulin or both. There are several types of diabetes, but type 2 diabetes is the most frequent form.

 

Diabetes mellitus not only induces dental pulp metabolic changes, but also it has been shown that it can influence both sensory and vascular structures. Therefore, it can be hypothesized that diabetes might affect pulp responses to sensibility tests. Pulpal sensibility tests, such as the cold, heat, and electric pulp tests (EPT) are important tools in endodontic diagnosis. The cold test is one of the most common endodontic diagnostic tests for the indirect assessment of the pulp vitality. It is usually performed in combination with EPT to increase the validity and reliability of the findings. This clinical trial aims to interpret and analyze the pulp sensibility in controlled Type II Diabetics and Healthy patients with symptomatic irreversible pulpitis.

 
Close