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

Not Applicable

Not yet recruiting

• Conditions: Class I Cavities in High Caries Risk; Class I Composite Restorations; Randomized Clinical Trial; Occlusal Caries; Fiber Reinforced Composite; Injectable Composite; Composite Restoration; Composite Resins

• Registration Number: NCT06924047
• Lead Sponsor: Dalia Sameh Fawzi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fracture	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 Outcome Measures

Name	Time	Method
Recurrent caries	T1: 1 week T2: 6months T3: 12 months	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.
Post operative sensitivity	T1: 1 week T2: 6months T3: 12 months	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".