| 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
|
|
|
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
|
|
|
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. |