| CTRI Number |
CTRI/2025/11/098121 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To check which Dental Filling Works Better for Treating Deep Cavities in Indian population |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY, TO EVALUATE AND COMPARE THE PERFORMANCE OF CONVENTIONAL AND RESIN MODIFIED GLASS IONOMERS FOR PULP THERAPY IN A SOUTH ASIAN INDIAN POPULATION. |
| 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 Navin S Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
TPCTs Terna Dental College |
| Address |
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
07738910957 |
| Fax |
|
| Email |
agarwalnavin98.na@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navin S Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
TPCTs Terna Dental College |
| Address |
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
07738910957 |
| Fax |
|
| Email |
agarwalnavin98.na@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navin S Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
TPCTs Terna Dental College |
| Address |
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Thane
MAHARASHTRA
400706
India |
| Phone |
07738910957 |
| Fax |
|
| Email |
agarwalnavin98.na@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Navin S Agarwal |
| Address |
22/206, Laxmi colony, Rajiv Niwas, R.c.Marg, Chembur (E), Mumbai 400074 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Navin S Agarwal |
TERNA DENTAL COLLEGE AND HOSPITAL. |
Terna Dental College, Department of Conservative dentistry and Endodontics,2nd floor, Room no 205, Plot no 12, Terna Campus road, opp railway station, Nerul west, sector 22, Navi Mumbai 400706.
Thane
MAHARASHTRA |
7738910957
agarwalnavin98.na@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TPCTs TERNA DENTAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premolar Decided for Orthodontic extraction |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Glass ionomer Cement |
Direct and indirect pulp capping using Conventional Glass ionomer cement |
| Comparator Agent |
Resin Modified Glass ionomer cement |
Direct and indirect pulp capping using Resin modified Glass ionomer cement |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
For Clinical Arm
1.Participants in the age group of 15 to 52 years.
2.An intraoral periapical radiograph of the tooth shows complete root formation.
3.Those teeth which will be diagnosed as having reversible pulpitis will be included.
4.Permanent maxillary and mandibular posteriors.
For Histological Arm
1.Participants in the age group of 13 to 32 years.
2.The tooth should be caries free and scheduled for orthodontic extraction
3.An intraoral periapical radiograph of the tooth shows complete root formation and normal periapical area with no pathosis, no periodontal defects and resorptions.
|
|
| ExclusionCriteria |
| Details |
For Clinical Arm
1.Participants with teeth diagnosed as having irreversible pulpitis from their history, clinical examination or vitality tests.
2.Presence of a sinus tract or periodontal inflammation, mobility of tooth with poor prognosis, cracked tooth, furcation involvement, resorptive defects, or calcification of the root canal.
3.During the clinical procedure of the participant included in the study, if it will be observed that the pulpal hemorrhage could not be controlled and the same lasted for more than 10 minutes.
For Histological Arm
1.Carious premolar, cervical or occlusal defects.
2.An intraoral periapical radiograph of the tooth shows incomplete root formation or any periapical pathology, periodontal defects or resorptions.
|
|
|
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 |
For Clinical Arm:
Clinical and radiographic outcomes.
Recording self-reports from participants (S) using Visual analogue scale (VAS).
• Clinical inspection of the tooth (I)
• Evaluating radiographs for normal and pathological changes (R)
• Testing the pulp-capped teeth for vitality by electric and cold tests (V)
• Palpation (PA)
• Percussion (PE)
• Mobility (M)
• Probing depths (PD).
For Histologic Arm:-
1. Odontoblastic changes.
2. Inflammatory changes.
3. Tertiary dentin formation.
4. Presence of micro-organisms
|
For Clinical Arm:
Patients will be evaluated in 24 hours, 3 weeks, 3 months, 6 months.
For Histologic Arm:-
Patients will be evaluated in 7 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="265"
Sample Size from India="265"
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)
|
15/12/2025 |
| 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="4"
Months="0"
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
|
Aim/ Purpose: - To evaluate and compare the Success Outcomes of Direct and Indirect pulp capping on permanent posterior teeth using Conventional and Resin Modified GIC. Null hypothesis: - There is no difference in the success outcomes of pulp capping on permanent posterior teeth using conventional and resin modified GIC. Alternate hypothesis: - There is a difference in the success outcomes of pulp capping on permanent posterior teeth using conventional and resin modified GIC. Objectives: - 1. To evaluate the histological findings in premolars which are capped (direct or indirect) with conventional GIC as a pulp capping agent. 2. To evaluate the histological findings in premolars which are capped (direct or indirect) with resin modified GIC as a pulp capping agent. 3. To evaluate the radiographic findings in permanent posterior teeth with reversible pulpitis which are capped (direct or indirect) with conventional GIC as a pulp capping agent. 4. To evaluate the radiographic findings in permanent posterior teeth with reversible pulpitis which are capped (direct or indirect) with resin modified GIC as a pulp capping agent. 5. To evaluate the clinical response in permanent posterior teeth with reversible pulpitis which are capped (direct or indirect) with conventional GIC as a pulp capping agent. 6. To evaluate the clinical response in permanent posterior teeth with reversible pulpitis which are capped (direct or indirect) with resin modified GIC as a pulp capping agent. 7. To compare the Histological findings in premolars which are Capped (Direct or Indirect) With Conventional or Resin Modified GIC as a pulp capping agent. 8. To compare the Radiographic changes in Teeth with Reversible Pulpitis which are Capped (Direct or Indirect) With Conventional or Resin Modified GIC as a pulp capping agent. 9. To compare the Clinical response in Teeth with Reversible Pulpitis which are Capped (Direct or Indirect) With Conventional Or Resin Modified GIC as a pulp capping agent.
|