NCT07147036

Effectiveness of Biodentine v/s Calcium Hydroxide as Indirect Pulp Capping Materials

Comparison of Effectiveness of Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Material in Mature Permanent Teeth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Zahoor khan · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study compares the clinical and radiographic effectiveness of Biodentine and Calcium Hydroxide as indirect pulp capping materials in mature permanent teeth with reversible pulpitis. A total of 76 patients were randomly assigned to two groups. Outcomes were assessed over 12 weeks based on pain, periapical radiolucency, and PDL widening. The goal was to determine which material better preserves pulp vitality

Detailed description

Introduction: Preservation of pulp vitality is critical for the long-term health and functionality of teeth. The pulp can be compromised due to caries, trauma, or iatrogenic factors. One conservative treatment to preserve pulp vitality in teeth with deep carious lesions and reversible pulpitis is indirect pulp capping (IPC). Traditionally, Calcium Hydroxide (Ca(OH)₂) has been the gold standard material for IPC due to its antibacterial properties and its ability to stimulate the formation of reparative dentin. However, it has several limitations such as poor bonding to dentin, high solubility, and low mechanical strength, which may affect long-term success. Biodentine, a newer bioactive dentin substitute, has emerged as a potential alternative due to its biocompatibility, bioactivity, antibacterial effect, good sealing ability, and high compressive strength. These properties suggest Biodentine may offer superior clinical outcomes in preserving pulp vitality when used as an indirect pulp capping material. Objective: To compare the clinical and radiographic effectiveness of Biodentine versus Calcium Hydroxide as indirect pulp capping agents in mature permanent teeth with reversible pulpitis. Study Design: Type: Experimental comparative study Setting: Department of Operative Dentistry \& Endodontics, HITEC-IMS, Taxila Duration: 1 year (after IRB approval) Sample Size: 76 patients (38 in each group), calculated using WHO sample size calculator Sampling Technique: Non-probability consecutive sampling Inclusion Criteria: Patients aged 20-45 years Teeth with occlusal carious lesions with ICDAS radiographic score RC-5 Vital teeth with signs of reversible pulpitis No signs of root resorption Exclusion Criteria: Teeth tender to percussion Irreversible pulpitis or non-vital pulp Medically compromised or pregnant patients Third molars or teeth with pulp exposure during caries excavation Materials Used: Group I: Biodentine (Septodont, France) Group II: Calcium Hydroxide (Dycal) Base Material: Self-cure Glass Ionomer Cement (Fuji, Japan) Final Restoration: Light-cure composite resin Disinfectant: 0.2% Chlorhexidine Vitality Tests: Cold test and electric pulp test Caries Removal: Round bur (#BR-45) under copious water spray Isolation: Rubber dam Procedure: Pre-operative Steps: Informed consent obtained Patient assessment: history, clinical examination, vitality testing, radiographs Operative Steps: Group I (Biodentine): Caries removed and cavity prepared Biodentine mixed per manufacturer's instructions and placed After 1 week, a GIC base applied Final composite restoration placed Post-op radiograph taken Group II (Calcium Hydroxide): Caries removed and cavity dried 0.5 mm Dycal applied and allowed to set (2-3 min) GIC base placed immediately afterward Final composite restoration after 1 week Post-op radiograph taken Follow-Up Intervals: 2 weeks 6 weeks 12 weeks Evaluation Criteria: Clinical Parameters: Pain (reversible or persistent) Tenderness to percussion Response to pulp vitality tests Radiographic Parameters: Presence or absence of periapical radiolucency Periodontal ligament (PDL) space widening Data Collection Tool: Data was recorded using a structured proforma (Annexure-C), documenting all clinical and radiographic parameters at baseline and follow-up intervals. Statistical Analysis: Software: SPSS Version 26 Quantitative Variables: Mean ± standard deviation (e.g., age, weight) Qualitative Variables: Frequency and percentage (e.g., pain, radiographic changes) Test Used: Chi-square test Level of Significance: p \< 0.05 considered statistically significant Ethical Considerations: Approved by Institutional Review Board (IRB) and College Ethical Committee Written informed consent obtained in both English and Urdu Patient confidentiality strictly maintained Participants allowed to withdraw at any time without affecting treatment Budget and Funding: Funded by Dental College, HITEC-IMS, Taxila No financial burden on participants Estimated duration for study completion: 1 year Expected Outcome: The study aims to determine whether Biodentine, with its superior physical and biological properties, provides better clinical and radiographic outcomes in indirect pulp capping procedures compared to Calcium Hydroxide in mature permanent teeth.

Conditions

• Reversible Pulpitis

Interventions

Type	Name	Description
PROCEDURE	Biodentine - Indirect Pulp Capping	Caries removal under rubber dam isolation using round bur (#BR-45) and water spray Tooth disinfection with 0.2% chlorhexidine Mixing of Biodentine (Septodont, France) in an amalgamator (30 seconds at 4000 rpm) Placement of Biodentine into the prepared cavity using an amalgam carrier and condensation After 1 week: Placement of self-cure GIC (Fuji, Japan) as a base Final restoration with light-cure composite resin Follow-up at 2, 6, and 12 weeks
PROCEDURE	Calcium Hydroxide - Indirect Pulp Capping	Caries removal under rubber dam isolation using round bur (#BR-45) and water spray Tooth disinfection with 0.2% chlorhexidine Cavity dried with cotton pellet Placement of a 0.5 mm layer of Calcium Hydroxide (Dycal) After 2-3 minutes (setting time): Placement of self-cure GIC (Fuji, Japan) After 1 week: Final restoration with light-cure composite resin Follow-up at 2, 6, and 12 weeks

Timeline

• Start date: 2023-02-05
• Primary completion: 2024-02-05
• Completion: 2024-02-05
• First posted: 2025-08-28
• Last updated: 2025-09-15

Locations

1 site across 1 country: Pakistan