| CTRI Number |
CTRI/2025/07/090523 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare two agents which are considered to form hard tissue within the tooth. |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic Evaluation of 3Mixtatin and MTA as Pulp Capping Agents: A Randomized Controlled 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 S Srija Mili |
| Designation |
PG Student |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India |
| Phone |
08897300388 |
| Fax |
|
| Email |
ssmili401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Swathi |
| Designation |
HOD, Professor |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India |
| Phone |
09866021672 |
| Fax |
|
| Email |
drswathi.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Srija Mili |
| Designation |
PG Student |
| Affiliation |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
| Address |
Department of Conservative Dentistry and Endodontics, Room no. 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India |
| Phone |
08897300388 |
| Fax |
|
| Email |
ssmili401@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055, INDIA. |
|
|
Primary Sponsor
|
| Name |
Malla Reddy Dental College for Women |
| Address |
Department of Conservative Dentistry and Endodontics, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055. |
| 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 S Srija Mili |
MALLA REDDY DENTAL COLLEGE FOR WOMEN |
Department of Conservative Dentistry and Endodontics, Room No. 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA |
08897300388
ssmili401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MALLA REDDY DENTAL COLLEGE FOR WOMEN INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3Mixtatin |
It is a combination of 100mg Metronidazole, 100mg Ciprofloxacin, 100mg Cefixime, and 2mg Simvastatin. These 4 agents are mixed with the help of saline and made into a paste. After the deep caries excavation in the tooth, 3Mixtatin in a required amount is applied as a layer over the unexposed pulp, followed by a restoration over it. It is expected to promote healing and form a dentin bridge over the pulp. |
| Comparator Agent |
MTA (Mineral trioxide aggregate) |
After the deep caries excavation in the tooth, MTA in a required amount is applied as a layer over the unexposed pulp, followed by a restoration over it. MTA promotes healing and forms a dentin bridge over the pulp. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Deep carious lesion penetrating three-quarters or more into dentine as identified with periapical (PA) radiograph; Clinically mICDAS score 4 (Banerjee and Watson 2011)
2. Clinical symptoms of reversible pulpitis.
3. Presence of at least 2/3rds of root length radiographically, & restorability of selected teeth were also confirmed.
4. Positive pulp response to electric pulp test or thermal stimulation.
5. No PA changes on PA radiographs.
|
|
| ExclusionCriteria |
| Details |
1. Signs or symptoms more severe than reversible pulpitis.
2. Radiographic evidence of pulp degeneration such - widening of periodontal ligament space,
internal and external resorption of the root (IRR and ERR),
3. Pulp necrosis
4. Furcal radiolucency or inter radicular bone destruction (FR/IBD) and/or
5. Periapical bone destruction (PBD).
6. Pregnant women (in view of requirements for radiographs).
7. Patients unable to give consent.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the clinical and radiographic efficacy of 3Mixtatin and MTA when used as pulp capping agents in permanent teeth using the CBCT.
|
1. Pre-operative PA radiograph and CBCT, followed by post-operative PA radiograph.
2. 1 month follow-up: PA radiograph.
3. 3 months follow-up: PA radiograph and CBCT taken.
4. 6 months follow-up: PA radiograph and CBCT taken. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| 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
|
MTA has an enhanced non-resorbable seal over the pulp and shows the ability to induce hard tissue formation due to the release of cytokines from bone cells. Due to a few drawbacks exhibited by MTA, there is a continuous look-out for new approaches and substances that stimulate the regenerative ability of dental tissues. Statin components are well known for their regenerative capacity. They enhance the activity of osteoblasts and decrease osteoclastic function, leading to an increase in the rate of formation of bone, and also exhibit potent anti-inflammatory properties and maintain the levels of pro-inflammatory cytokines. Assuming these properties might have a role in the regeneration of pulp and dentin, statins are used as a pulp capping agent in the form of 3Mixtatin. |