The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)

N/ANot Yet RecruitingNCT06924047

Dalia Sameh Fawzi50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Class I Cavities in High Caries Risk Class I Composite Restorations Randomized Clinical Trial Occlusal Caries Fiber Reinforced Composite

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients aged (20-50) 2. Medically free 3. Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus)) 4. Patients accepting to participate in the study. 5. Teeth of normal appearance and morphology 6. Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin. Exclusion Criteria: 1. Patients \<20 and \>50. 2. Teeth with proximal lesions. 3. Patients with bad oral hygiene (Plaque index \>2). 4. Systematic disease that may interfere with the study. 5. Patients with xerostomia. 6. Presence of any abnormal occlusal habits (bruxism, nail biting, clenching). 7. Patients undergoing or will start orthodontic treatment. 8. Pregnancy. 9. Teeth with signs or symptoms of irreversible pulpitis. 10. Non-vital, fractured or cracked teeth. 11. Teeth with secondary caries. 12. Periodontally compromised teeth.

Outcomes

Primary Outcomes

Fracture

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

Time frame: T1: 1 week T2: 6months T3: 12 months

Secondary Outcomes

Recurrent caries

1. Clinically excellent/very good (sufficient): No caries/demineralization at the restoration margin detectable after air drying. 2. Clinically good (sufficient): First visible signs of a non-cavitated caries lesion at the restoration margin detectable after air drying. 3. Clinically satisfactory (sufficient): Established, non- cavitated caries lesion or microcavity at the restoration margin detectable without air drying. 4. Clinically unsatisfactory (partially insufficient): Localized dentin cavity at the restoration margin. 5. Clinically poor (entirely insufficient): Extensive dentin cavity at the restoration margin.

Time frame: T1: 1 week T2: 6months T3: 12 months

Post operative sensitivity

1. Clinically excellent/very good (sufficient): No Postoperative hypersensitivity. 2. Clinically good (sufficient): Minor postoperative hypersensitivity. 3. Clinically satisfactory (sufficient) Distinct "moderate" postoperative hypersensitivity. 4. Clinically unsatisfactory (partially insufficient): Severe "persistent" postoperative hypersensitivity. 5. Clinically poor (entirely insufficient): Extreme postoperative hypersensitivity "Irreversible pulpitis".

Time frame: T1: 1 week T2: 6months T3: 12 months

The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts