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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- DrRavi Divya Lakshmi
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- To assess and compare the clinical and radiographic success of Bioactive glass with hyaluronic acid gel, MTA and formocresol
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children between the age group of 4-8 years, Frankel behavior scale of positive and definitely positive children will be included in the study
- •Vital primary molars with risk of carious pulp exposure
- •Absence of spontaneous pain or persistent pain or nocturnal pain
- •No clinical symptoms or evidence of pulp degeneration such as pain on percussion
- •Restorable tooth structure should be present
- •Hemorrhage from the amputation site is bright red and easy to control
- •Radiographic evidence of not more than one-third of physiologic root resorption
- •Absence of pathologic root resorption.
Exclusion Criteria
- •Any of the clinical or radiographic inclusion criteria are not met
- •Evidence of internal resorption
- •Presence of inter radicular bone loss
- •Abscess, fistula in relation to teeth
- •Any deleterious oral habits like bruxism will be excluded from the study
- •Children with poor oral hygiene will be excluded from the study.
Outcomes
Primary Outcomes
To assess and compare the clinical and radiographic success of Bioactive glass with hyaluronic acid gel, MTA and formocresol
Time Frame: 3, 6 and 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ravi Divya Lakshmi
SRM Dental College, Ramapuram