Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars

Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial

This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Tooth Demineralization; Tooth Diseases; Deep Caries; Teeth; Lesion; Dental Diseases; Tooth Decay; Dental Restoration Failure of Marginal Integrity; Caries; Dentin
• Intervention / Treatment: Other: selective caries removal and conventional non-bioactive restorative system; Other: selective caries removal and bioactive restorative system

Detailed Description

Deep carious lesions in permanent molars present a significant challenge in restorative dentistry. Traditional approaches to caries removal often involve the removal of excessive healthy tooth structure, leading to weakened teeth and potential pulp exposure. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue, offering a conservative alternative to traditional methods. In recent years, bioactive restorative materials have emerged as promising alternatives to conventional non-bioactive materials. Bioactive materials are designed to interact with the biological environment, promoting remineralization and potentially enhancing the longevity of restorations. However, limited evidence exists comparing the efficacy of bioactive and non-bioactive restorative systems in deep carious lesions treated with selective caries removal. This study is designed as a prospective, randomized controlled trial. Patients presenting with deep carious lesions in permanent molars will be randomly allocated to receive either a bioactive or non-bioactive restorative system following selective caries removal. Baseline demographic and clinical data will be recorded for each participant. Clinical evaluations will be conducted at regular intervals over a follow-up period of months. Outcome measures will include restoration integrity (e.g retention, marginal adaptation), pulpal response (e.g., sensitivity, vitality).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• young adult patients (age: 18-40 years) of both genders.
• Able to tolerate necessary restorative procedures.
• Willing to sign the informed consent.
• Accepts the follow-up period.
• Posterior permanent tooth with occlusal proximal deep carious lesion.
• Radiographically (bitewing radiograph) extending to the inner 1/3 of dentine (D3) with a radiopaque layer between the carious lesion and the pulp chamber.
• Sensible teeth according to cold pulp test.

Exclusion criteria:

• Allergy to any restorative materials.
• Patients undergoing orthodontic treatment with fixed appliances.
• Pregnant women.
• Patients with debilitating systemic diseases
• Teeth with previous restorations.
• Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
• Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
• Mobile teeth, indicating periodontal disease or trauma.
• External or internal resorption.
• Cervical carious lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional non-bioactive restorative system (Comparator); deep carious molars restored with conventional resin based restorative system	Other: selective caries removal and conventional non-bioactive restorative system; conventional dental restorative adhesive and resin based composite
Active Comparator: Bioactive system (Intervention); deep carious molars restored with bioactive resin based restorative system	Other: selective caries removal and bioactive restorative system; bioactive dental restorative resin based system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5	excellent(No hypersensitivity,normal vitality; good(Minor hypersensitivity for a limited time,normal vitality; satisfactory(Moderate hypersensitivity-Delayed/mild sensitivity;no subjective complaints,no treatment needed; unsatisfactory(Intense hypersensitivity-Delayed with minor subjective symptoms-No detectable sensitivity-Intervention necessary but not replacement; poor(Intense, acute pulpitis or non-vital tooth-Endodontic treatment is necessary and restoration replacement	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success or Failure	Binary Outcome Success (Score 1,2&3) Failure (Score 4 &5)	18 months
Functional properties - fracture&retention-marginal adaptation-Radiographic Examination"when applicable"-Scoring system Ordinal 1-5	excellent Frac&Ret:No fractures /Cracks Marginal Adaptation:Harmonious outline,no gaps,white or discolored lines Radiograph:No pathology,harmonious transition between restoration &Tooth; good Frac&Ret:Small hairline crack Marginal Adaptation:Marginal gap(<150 μm),white line-Small marginal fracture removable by polishing-Slight ditching,slight step/flashes,minor irregularities Radiograph:Acceptable material excess present-Positive/negative step present at margin <150 μm; satisfactory Fract and Ret:Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact Marginal Adaptation:Gap<250μm not removable-Several small marginal fractures-Major irregularities,ditching or flash,steps Radiograph:Marginal gap<250 μm-Negative steps visible<250 Μm-No adverse effects Noticed-Poor radiopacity of filling	18 months
Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)	= excellent (No secondary or primary caries); = good (Small and localized 1.Demineralization 2. Erosion or 3. Abfraction); = satisfactory (Larger areas of 1.Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed) (Only preventive measures necessary); = unsatisfactory (Caries with cavitation and suspected undermining caries) (Erosion in Dentine) (Abrasion/abfraction in dentine) (Localized and accessible can be repaired).; = poor (Deep caries or exposed dentine that is not accessible for repair of restoration)	18 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rct; self-etch adhesive; partial caries removal; selective caries removal; bioactivity; deep caries in permanent molars; bioactive restorative system; selective removal to soft caries; bioactive adhesive; bioactive bond; deep carious molars
• Additional Relevant MeSH Terms: Dental Caries; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization
• Other Study ID Numbers: Bioactive restorative system

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes