| CTRI Number |
CTRI/2025/12/099058 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Regenerative Potential of Phenytoin, Metformin and MTA |
|
Scientific Title of Study
|
Comparative Evaluation of Phenytoin, Metformin and Mineral Trioxide Aggregate as a Direct Pulp Capping Agents Using Cone Beam Computed Tomography - A Randomised Controlled 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 |
Aswini N |
| Designation |
PG Student |
| Affiliation |
Tamil Nadu Government Dental College and Hospital, chennai |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Esplanade, George Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9094947757 |
| Fax |
|
| Email |
aswininalathati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aswini N |
| Designation |
PG Student |
| Affiliation |
Tamil Nadu Government Dental College and Hospital, chennai |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Esplanade, George Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9094947757 |
| Fax |
|
| Email |
aswininalathati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Kavitha |
| Designation |
Professor and HOD |
| Affiliation |
Tamil Nadu Government Dental College and Hospital, chennai |
| Address |
Department of Conservative Dentistry and Endodontics, Tamilnadu Government Dental College and Hospital, Chennai
Esplanade, George Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9841161131 |
| Fax |
|
| Email |
kavithaendo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tamilnadu Government Dental College and Hospital, Esplanade, George town, Chennai 600003 |
|
|
Primary Sponsor
|
| Name |
Aswini N |
| Address |
Tamil Nadu Government Dental College and Hospital, Muthusamy salai, Esplanade George Town,Chennai - 600003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Aswini N |
Tamilnadu government dental college and hospital |
Department of conservative dentistry and Endodontics,
Room No. 1- 10 Chennai TAMIL NADU
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9094947757
aswininalathati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TamilNadu Government Dental College and Hospital Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin gel |
Metformin gel was prepared using dispersion method. 1% of metformin, 3% mannitol and sucrose 0.5% and preservative methyl paraben 0.05% was added stirred continuously at room temperature and carbopol 940 was used to prepare the gel. After placing the gel, patient will be followed for 6 months |
| Comparator Agent |
Mineral Trioxide Aggregate(MTA) |
Commercially Available, after placing MTA over pin point exposure of pulp, patient will be followed for 6 months |
| Intervention |
Phenytoin gel |
Phenytoin gel was prepared using dispersion method. 0.25% of phenytoin, 1.5% of mannitol, sucrose and preservative added stirred continuously at room temperature. 2% of carbopol 940 was used to prepare the gel. After placing gel as direct pulp capping agent, patient will be followed for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18-45 years of either gender
Patients with asymptomatic maxillary and mandibular premolars and molars with radiographic evidence of deep caries approximating the pulp chamber
Absence of tenderness to percussion and positive response to cold and electric pulp testing with good oral hygiene and no systemic disease
|
|
| ExclusionCriteria |
| Details |
Symptomatic teeth
Evidence of periapical pathology
Negative response to pulp vitality testing
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Absence of tenderness to percussion and positive response to cold and electric pulp testing
|
3 and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evidence of Dentin Bridge formation |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/02/2026 |
| 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="0"
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
|
This study is a randomized, double blinded, parallel arm design comparing the effect of phenytoin, metformin and mineral trioxide aggregate as direct pulp capping agents using cone beam computed tomography (CBCT) carried out in Tamil Nadu Government Dental college and Hospital among 30 patients of age group from 18 to 45 years of both gender with radiographic evidence of deep caries approximating the pulp chamber, absence of tenderness to percussion and positive response to cold and electric pulp testing . The primary outcome should be absence of tenderness to percussion and positive response to cold and electric pulp testing . The secondary outcome being radiographic evidence of dentin bridge formation during 3 and 6 months periods of post operative evaluation using CBCT and digital intraoral radiograph. |