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

NCT ID: NCT07147036

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2024-02-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Biodentine Group

Participants receive Biodentine as the indirect pulp capping material

Group Type: EXPERIMENTAL

Biodentine - Indirect Pulp Capping

Intervention Type: PROCEDURE

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

Calcium Hydroxide Group

Participants receive Calcium Hydroxide (Dycal) as the indirect pulp capping material

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide - Indirect Pulp Capping

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following criteria to be included in the study:

• Age: 20 to 45 years.
• Tooth Type: Mature permanent teeth (maxillary or mandibular).
• Caries Status: Occlusal carious lesions without previous restorations.
• Pulpal Diagnosis: Reversible pulpitis confirmed by:
• Patient history and clinical examination
• Positive response to thermal (cold) and electric pulp tests
• No tenderness to percussion
• Radiographic Assessment: Carious lesion corresponding to ICDAS radiographic score RC-5.
• Periapical Status: No signs of periapical radiolucency or root resorption on radiograph.

Exclusion Criteria

• Participants will be excluded if they meet any of the following:
• Teeth exhibiting signs of irreversible pulpitis or pulp necrosis.
• Tenderness to percussion on clinical examination.
• Pulp exposure during caries removal.
• Systemic conditions that may interfere with healing or immune response, including:

Chronic systemic illness

Immunocompromised status

Pregnancy

-Third molars (due to anatomical and treatment variability)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HITEC-Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Zahoor khan

OTHER

Sponsor Role: lead

Responsible Party

Zahoor khan

Dr Zahoor khan, Resident operative dentistry & endodontics, HITECIMS taxila pakistan

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr Zahoor Dr Zahoor khan, BDS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Dental college HITEC-IMS Taxila

Dr Zahoor khan

Role: PRINCIPAL_INVESTIGATOR

Dental college HITEC-IMS Taxila

Locations

HITEC-IMS Taxila

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5364749/

In above URL section the related article link has been provided just for reference \& support of study as my study has not been published yet

Other Identifiers

Dental/HITEC/IRB/41

Identifier Type: -

Identifier Source: org_study_id