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

NCT07147036 | Completed

• 1 other identifier: Dental/HITEC/IRB/41
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Reversible Pulpitis

Outcome Measures

Primary Outcomes (4)

• Radiographic assessment by Periapical Index (PAI)

  PAI Scoring Criteria: Score Radiographic Features Interpretation 1. Normal periapical structures Healthy PDL and periapical tissues 2. Small changes in bone structure (slight PDL widening) Mild changes; potentially reversible 3. Changes in bone structure with mineral loss Moderate periapical inflammation 4. Well-defined radiolucent area Established periapical periodontitis 5. Severe radiolucency with bone destruction Advanced periapical disease Application in my Study: At each follow-up (2, 6, 12 weeks), periapical radiographs should be: Evaluated using the PAI score Compared to baseline radiographs Scores ≤2 are generally considered favorable outcomes Scores ≥3 indicate disease or failure

  Follow-up Timeline for Each Patient: Patients will be evaluated at the following intervals after the indirect pulp capping procedure: Baseline (Initial Treatment) 2 weeks follow-up 6 weeks follow-up 12 weeks follow-up

• Visual Analog Scale (VAS) for Pain Measurement

  1\. Pain Assessment Type: Spontaneous or provoked Tool: Patient history and Visual Analog Scale (VAS) for Pain Measurement Classification: No pain Mild/transient pain (indicative of successful pulp healing) Moderate to severe pain (suggestive of pulpal inflammation or failure) Interpretation: Absence of pain considered a positive outcome. Persistent or worsening pain may indicate treatment failure or progression to irreversible pulpitis Visual Analog Scale (VAS) for Pain Measurement Description: A 10 cm horizontal line representing a continuum of pain intensity. One end (0 cm) represents "No pain", and the other end (10 cm) represents "Worst possible pain". Scoring Criteria: VAS Score (cm) Pain Intensity 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe pain Application in my Study: Patients can be asked to mark their pain level on the scale at: Baseline 2-week 6-week 12-week follow-up visits

  Patients pain level can be measured on the scale at: Baseline 2-week 6-week 12-week follow-up visits

• Tenderness to Percussion

  2\. Tenderness to Percussion Tool: Blunt end of dental mirror gently tapped on the occlusal surface Response Categories: Absent: No discomfort or pain on percussion (favorable response) Present: Pain on percussion, indicating potential periapical inflammation or pulp degeneration Interpretation: Lack of tenderness is a favorable clinical outcome. Positive percussion response may suggest underlying periapical involvement or pulpal pathology.

  Patients tenderness to percussion will be checked at: Baseline 2-week 6-week 12-week follow-up visits

• Pulp Vitality Testing : Cold test (Endo-Ice or refrigerant spray on cotton pellet) and Electric Pulp Test (EPT)

  Pulp Vitality Testing Methods Used: Cold test (Endo-Ice or refrigerant spray on cotton pellet) Electric Pulp Test (EPT) Response Categories: Normal response: Short, sharp, non-lingering sensation (indicative of vital pulp) Exaggerated or lingering pain: Suggestive of reversible/irreversible pulpitis No response: Indicative of non-vital or necrotic pulp Interpretation: A normal response to cold or EPT at follow-up implies successful preservation of pulp vitality. No response or lingering pain may indicate pulp necrosis or treatment failure

  Patients tooth vitality testing will be done at: Baseline 2-week 6-week 12-week follow-up visit

Study Arms (2)

Biodentine Group

EXPERIMENTAL

Participants receive Biodentine as the indirect pulp capping material

Procedure: Biodentine - Indirect Pulp Capping

Calcium Hydroxide Group

ACTIVE COMPARATOR

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

Procedure: Calcium Hydroxide - Indirect Pulp Capping

Interventions

Biodentine - Indirect Pulp Capping 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

Biodentine Group

Calcium Hydroxide - Indirect Pulp Capping 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

Calcium Hydroxide Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zahoor khan: lead
• HITEC-Institute of Medical Sciences: collaborator

Study Sites (1)

HITEC-IMS Taxila

Rawalpindi, Punjab Province, 47080, Pakistan

Location

Related Links

• 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

Study Officials

• Dr Zahoor Dr Zahoor khan, BDS, FCPS

  Dental college HITEC-IMS Taxila

  PRINCIPAL INVESTIGATOR

• Dr Zahoor khan

  Dental college HITEC-IMS Taxila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Zahoor khan, Resident operative dentistry & endodontics, HITECIMS taxila pakistan

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 28, 2025
• Study Start: February 5, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)