Clinical trial NCT06348953: Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars
Official title: Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Dental Diseases
Deep Caries
Tooth Diseases
Tooth Decay
Teeth; Lesion
Caries; Dentin
Dental Restoration Failure of Marginal Integrity
Tooth Demineralization
Keywords: self-etch adhesive
deep caries in permanent molars
bioactive restorative system
selective caries removal
partial caries removal
selective removal to soft caries
bioactive adhesive
bioactive bond
bioactivity
deep carious molars
rct
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5
timeFrame: 18 months
Secondary outcomes:
measure: Functional properties - (fracture and retention)
timeFrame: 18 months
measure: Functional properties - Approximal anatomical form (contact point and contour)
timeFrame: 18 months
measure: continue Functional properties (Radiographic Examination -when applicable)
timeFrame: 18 months
measure: continue Functional properties ( marginal adaptation )
timeFrame: 18 months
measure: Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
timeFrame: 18 months
measure: Success or Failure
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
References: