The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Fracture
Study Overview
Brief Summary
Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients aged (20-50)
- •Medically free
- •Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
- •Patients accepting to participate in the study.
- •Teeth of normal appearance and morphology
- •Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.
Exclusion Criteria
- •Patients <20 and >
- •Teeth with proximal lesions.
- •Patients with bad oral hygiene (Plaque index >2).
- •Systematic disease that may interfere with the study.
- •Patients with xerostomia.
- •Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
- •Patients undergoing or will start orthodontic treatment.
- •Teeth with signs or symptoms of irreversible pulpitis.
- •Non-vital, fractured or cracked teeth.
- •Teeth with secondary caries.
- •Periodontally compromised teeth.
Arms & Interventions
Bioactive injectable composite
bioactive injectable composite placed as a dentine substitute
Intervention: Beautifil Flow Plus X (Other)
Short fiber reinforced composite
Short fiber reinforced composite added as a dentine substitute
Intervention: EverX Flow (Other)
Outcomes
Primary Outcomes
Fracture
Time Frame: T1: 1 week T2: 6months T3: 12 months
1. Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying. 2. Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying 3. Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying 4. Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention 5. Clinically poor (entirely insufficient): Generalized severe deficiencies
Secondary Outcomes
- Recurrent caries(T1: 1 week T2: 6months T3: 12 months)
- Post operative sensitivity(T1: 1 week T2: 6months T3: 12 months)
Investigators
Dalia Sameh Fawzi
Principle Investigator
Future University in Egypt