Comparative Evaluation Of Indirect Pulp Therapy In Young Permanent Teeth Using Nanohydroxyapatite And Epigallocatechin-3-Gallate (EGCG) Mix Versus Biodentine: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Post Operative Pain +/-, Tenderness on Percussion +/-, Abscess +/-
Study Overview
Brief Summary
Indirect Pulp Therapy (IPT) is a conservative treatment approach that preserves the vitality of pulp and promotes continued root development in young permanent teeth. Biodentine, a tricalcium silicate-based material, is currently the gold standard for IPT due to its biocompatibility, anti-inflammatory properties, and ability to induce dentin formation. However, there is growing interest in natural alternatives that enhance tissue healing and remineralization. Nanohydroxyapatite (nanoHA) closely resembles dentin’s natural composition, promoting calcium and phosphate deposition, while Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, provides antioxidant, antibacterial, and anti-inflammatory benefits. The combination of nanoHA and EGCG offers a novel approach for pulp healing and dentin regeneration by reducing bacterial activity, preserving dentin bond strength, and minimizing nanoleakage. This study aims to evaluate the in vivo effectiveness of the nanoHA and EGCG mix as an IPT agent in young permanent teeth and compare its performance with Biodentine, the current superior bioactive material.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1- Age Group- 6 to 15 years 2- Clinical: Young permanent posterior teeth with deep dentinal caries (ICDAS 5 & 6).
- •3- Radiographic: Teeth with carious lesion and open apices with no radiographic evidence of involvement of pulp.
Exclusion Criteria
- •1- Children with systemic disease and special healthcare needs.
- •2- Clinical: History of spontaneous pain and swelling, presence of abscess, pain with percussion, pathologic mobility.
- •3- Radiographic: Carious lesion involving pulp, periapical radiolucency, interrupted lamina dura, thickening of PDL space, internal/external root resorption and presence of pulp calcification.
Outcomes
Primary Outcomes
Post Operative Pain +/-, Tenderness on Percussion +/-, Abscess +/-
Time Frame: At Baseline, 1 Month, 3 Months, 6 Months
Secondary Outcomes
- Continued root development, PDL widening, Periapial pathology(at baseline, 1 month, 3 months, 6 months)