| CTRI Number |
CTRI/2025/08/093786 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of three different Pulpotomy agents in Primary molars |
|
Scientific Title of Study
|
Evaluation and Comparison of Clinical and Radiographic Outcomes of Bioactive Glass with Hyaluronic Acid gel, MTA and Formocresol as Pulpotomy Agents in Primary Molars: An Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Divya Lakshmi |
| Designation |
Postgraduate |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Pediatric and Preventive Dentistry, Dental, room no.8, SRM Dental College,
Bharathi Salai, Ramapuram,
Chennai - 600 089, Tamil Nadu, India.
Chennai TAMIL NADU 600089 India |
| Phone |
8143632164 |
| Fax |
|
| Email |
divyagolamari16@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Shankar.P |
| Designation |
Reader |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Pediatric and Preventive Dentistry, dental, room no - 8, SRM Dental College,
Bharathi Salai, Ramapuram,
Chennai - 600089, Tamil Nadu, India.
Chennai TAMIL NADU 600089 India |
| Phone |
9884585808 |
| Fax |
|
| Email |
shankarp1@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Ravi Divya Lakshmi |
| Designation |
Postgraduate |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Pediatric and Preventive Dentistry, dental, room no - 8, SRM Dental College,
Bharathi Salai, Ramapuram,
Chennai - 600089, Tamil Nadu, India.
Chennai TAMIL NADU 600089 India |
| Phone |
8143632164 |
| Fax |
|
| Email |
divyagolamari16@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrRavi Divya Lakshmi |
| Address |
Department of Pediatric and Preventive Dentistry, dental, room no -8, SRM Dental College,
Bharathi Salai, Ramapuram,
Chennai -600089 |
| 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 |
| Ravi Divya Lakshmi |
SRM Dental College |
Department of Pediatric and Preventive Dentistry, dental, room no - 8, SRM Dental College,
Bharathi Salai, Ramapuram,
Chennai
Tamil Nadu Chennai TAMIL NADU |
8143632164
divyagolamari16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB, SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing three pulpotomy agents in primary molars |
Intervention- Bioactive glass with hyaluronic acid gel pulpotomy
Comparative agent- MTA pulpotomy
Control group- Formocresol pulpotomy
In primary molars |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 4-8 years, Frankel behavior scale of positive and definitely positive children will be included in the study
2. Vital primary molars with risk of carious pulp exposure
3. Absence of spontaneous pain or persistent pain or nocturnal pain
4. No clinical symptoms or evidence of pulp degeneration such as pain on percussion
5. Restorable tooth structure should be present
6. Hemorrhage from the amputation site is bright red and easy to control
7. Radiographic evidence of not more than one-third of physiologic root resorption
8. Absence of pathologic root resorption
|
|
| ExclusionCriteria |
| Details |
1. Any of the clinical or radiographic inclusion criteria are not met
2. Evidence of internal resorption
3. Presence of inter radicular bone loss
4. Abscess, fistula in relation to teeth
5. Any deleterious oral habits like bruxism will be excluded from the study
6. Children with poor oral hygiene will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the clinical and radiographic success of Bioactive glass with hyaluronic acid gel, MTA and formocresol
|
3, 6 and 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
15/09/2025 |
| 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)
|
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
|
Introduction: Pulpotomy is a vital pulp therapy that preserves primary teeth by removing infected coronal pulp and applying medicaments to maintain the vitality of the radicular pulp. While Formocresol and MTA are commonly used, they have drawbacks such as cytotoxicity (Formocresol) and long setting time (MTA). Bioactive Glass, known for its biocompatibility and regenerative potential, and Hyaluronic Acid Gel, with its anti-inflammatory and healing properties, may offer a synergistic and biologically favorable alternative. This study will be among the first to evaluate their combined efficacy in pulpotomy for primary molars. Aim: To evaluate and compare the clinical and radiographic outcomes of Bioactive Glass with Hyaluronic Acid Gel, MTA, and Formocresol as pulpotomy agents in primary molars at 3, 6, and 12 months. Materials and Methodology: An observational study will be conducted on 45 children aged 4–8 years visiting a private dental college in Chennai. The sample size was calculated using G* power software. Clinical and radiographic assessments will be performed at 3, 6, and 12 months. Data will be analyzed using SPSS software with GEE or Repeated Measures Logistic Regression, McNemar’s test for pairwise comparisons, and significance set at p < 0.05. Results: The study will report on the comparative clinical and radiographic success rates of the three pulpotomy agents over time, identifying any statistically significant differences. Conclusion: If successful, the combination of Bioactive Glass and Hyaluronic Acid Gel may serve as a superior alternative to traditional pulpotomy agents, promoting safer, regenerative, and more effective vital pulp therapy in pediatric dentistry. |