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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
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
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
HITEC-IMS Taxila
Rawalpindi, Punjab Province, Pakistan
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
Time frame: 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
Time frame: 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.
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Time frame: 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
Time frame: Patients tooth vitality testing will be done at: Baseline 2-week 6-week 12-week follow-up visit