| CTRI Number |
CTRI/2025/09/095428 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study on Pulpotomy Treatment in Diabetic and Non Diabetic patients with Toothache Due to Pulpitis |
|
Scientific Title of Study
|
Clinical and Radiographic Assessment of Pulpotomy in Diabetic and Non Diabetic individuals with Symptomatic Pulpitis A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| vijethabadami |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kodipyaka Sushmitha |
| Designation |
Post Graduate |
| Affiliation |
MNR Dental College and Hospital |
| Address |
MNR Dental College and Hospital
Dept of Conservative Dentistry and Endodontics
Room no 7
Medak
TELANGANA
502294
India |
| Phone |
7675058517 |
| Fax |
|
| Email |
sushmithakodipyaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijetha Badami |
| Designation |
Professor and Head |
| Affiliation |
MNR Dental College and Hospital |
| Address |
MNR Dental College and Hospital
Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
9160022422 |
| Fax |
|
| Email |
Vijetha.mds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kodipyaka sushmitha |
| Designation |
Post Graduate |
| Affiliation |
MNR Dental College and Hospital |
| Address |
MNR Dental College and Hospital
Room no 7
First floor
Sangareddy
Medak
TELANGANA
502294
India |
| Phone |
7675058517 |
| Fax |
|
| Email |
sushmithakodipyaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR Dental College and Hospital
Fasalwadi
Sangareddy
502294
India |
|
|
Primary Sponsor
|
| Name |
Kodipyaka Sushmitha |
| Address |
MNR Dental College and Hospital
Fasalwadi
Sangareddy
502294 |
| Type of Sponsor |
Private medical college |
|
|
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 Kodipyaka Sushmitha |
MNR Dental College and Hospital |
MNR Dental College and Hospital
Sangareddy
502294
Medak
TELANGANA |
7675058517
sushmithakodipyaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR INSTITUTIONAL ETHICAL 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 |
Biodentin in diabetic participants |
Biodentin from Septodont a calcium silicate based pulpotomy material |
| Comparator Agent |
Biodentin in non diabetic participants |
Biodentin from Septodont a calcium silicate based pulpotomy material |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy and controlled diabetics with HbA1c value (5.7 to 7)
Premolars and molars diagnosed with symptomatic pulpitis
Presence of large carious lesions radiographically
Moderate to severe pain with positive pulp sensibility tests
Vital pulp tissue visible upon accessing the pulp chamber
Hemostasis achieved within 10 minutes after pulpotomy
|
|
| ExclusionCriteria |
| Details |
1) Patients with ASA III,IV,V,VI
2) Pregnant women
3) Necrotic pulp or non-vital teeth
4)Teeth with periapical lesions
5)Presence of internal or external tooth resorption
Failure to control bleeding within 10 minutes of the procedure
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
CLINICAL OUTCOMES:
1 Absence of signs and symptoms of symptomatic pulpitis
2 absence of swelling or sinus tract
3 Absence of abnormal tooth mobility
RADIOGRAPHIC OUTCOMES
1 No sign of internal or external root resorption
2 No new periapical pathosis
3 Formation of hard tissue barrier |
24hours 1week 12weeks 24weeks 48weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of pulpotomy procedures in controlled diabetic and nondiabetic individuals diagnosed with symptomatic irreversible pulpitis. Participants will be allocated into two parallel groups (diabetic and nondiabetic) and will undergo a standardized pulpotomy treatment using biocompatible materials. Clinical parameters such as pain tenderness mobility along with radiographic findings ( periapical status,internal or extrnal resorption,hard tissue barrier formation), will be assessed at baseline 1month 3 months 6 months and 12 months post-treatment. The study seeks to determine whether systemic diabetic status influences the healing outcome and success of pulpotomy treatment in mature permanent teeth.
|