This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of Nanohydroxyapatite Versus Biodentine After Selective Caries Removal Over One Year Follow-up

Not Applicable

Not yet recruiting

• Conditions: Deep Carious Lesions; Partial Caries Removal; Dentin Bridge

• Registration Number: NCT07171775
• Lead Sponsor: Cairo University

Brief Summary

This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 4-6). A total of 50 patients will be enrolled and randomly allocated to receive either nanohydroxyapatite or Biodentine as the pulp protection material. Clinical assessments and radiographic evaluations using three-dimensional imaging will be performed to measure the quality and extent of dentin bridge formation. Outcomes will be monitored and compared between baseline and 6 months, and between baseline and 12 months, to determine the effectiveness of each material in preserving pulp vitality and promoting reparative dentin formation.

Detailed Description

This randomized controlled clinical trial is designed to investigate the effectiveness of two bio-inductive materials-nanohydroxyapatite and Biodentine-in promoting dentin bridge formation following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 4-6).

A total of 50 patients presenting with deep caries in permanent teeth will be recruited according to specific inclusion and exclusion criteria. After selective removal of carious dentin, the cavity will be managed by applying either nanohydroxyapatite or Biodentine as the pulp protection material. Random allocation will be employed to ensure equal distribution between the two treatment groups.

Clinical assessments will include evaluation of pulp vitality and assessment of pain. Radiographic assessments will be conducted using three-dimensional imaging techniques, allowing precise evaluation of the presence, thickness, and continuity of the dentin bridge formed over the pulp.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-06
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-18
• Study Start: 2026-06-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patient-related criteria:

1. Adult patients (age: 18-40 years) of both genders.
2. Good oral hygiene.
3. Willing to sign the informed consent.
4. Cooperative patients who accept the follow-up period.

Tooth-related criteria:

1. Posterior permanent caries (ICDAS 4-6).
2. Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
3. Sensible teeth according to the cold pulp test.
4. Negative response in percussion test.

Exclusion Criteria

Patient-related criteria:

1. Allergy to any of the restorative materials.
2. Patients undergoing orthodontic treatment with fixed appliances.
3. Pregnant women.
4. Patients with debilitating systemic diseases.
5. Patient who frequently uses analgesics or any drugs that could mask the pain.

Tooth-related criteria:

1. Teeth with previous restorations.
2. Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.
3. Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.
4. Mobile teeth, indicating periodontal disease or trauma.
5. External or internal resorption.
6. Chipped teeth or Cuspal loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical assessment of Pulp sensibility.	12 months	Electrical pulp test

Secondary Outcome Measures

Name	Time	Method
Clinical assessment of pain.	12 months	(Patient-reported outcome measures) by Visual analogue scale The Visual Analogue Scale (VAS) will be used, by which 0 is no pain and 10 is severe pain.; Pictures will be added to the same, as well as colors to guide the patient during selection of pain severity.
Thickness and quality of Dentin bridge formation	12 months	Assess the dentin thickness by using the linear measurement tool and measuring the distance from the base of restoration to the pulp on sagittal, coronal, or cross-sectional images generated from CBCT scans after orientation of the orthogonal planes using the software's vertical and horizontal reference lines