Evaluation of the Clinical Performance of a Bulk Fill Resin Composite in Cuspal Coverage Restorations of Vital Posterior Teeth (RCT)

NCT07612462 · tracked via the Priya Life Science Egypt tracker

Sponsor

Future University in Egypt

Phase

Not applicable

Started

2025-12-01

Last updated

2026-05-28

Condition(s) studied

Cusp CappingCuspal CoverageTooth RestorationBulk Fill CompositeFracture Resistance

Investigational drug(s) / intervention(s)

Beautifil Bulk Fill (Shofu Inc.)

Beautifil Bulk Fill (Shofu Inc.): This intervention involves performing cuspal coverage restorations in posterior teeth using Shofu Beautifil Bulk Fill composite resin. The composite will be applied in a single increment following the manufacturer's adhesive and placement protocol. Each restoration will be evaluated clinically for wear resistance, fracture incidence, and recurrent caries during the follow-up period.

Study summary

This clinical study aims to compare bulk-fill and conventional composite resins in cuspal coverage restorations of posterior teeth. The primary outcomes include evaluating wear resistance, fracture incidence, and recurrent caries at different follow-up periods. Bulk-fill composites are designed for easier placement in thicker increments, potentially improving clinical efficiency. The study seeks to determine whether bulk-fill materials can provide comparable or superior performance to conventional composites in restoring structurally compromised teeth.

Eligibility

Sex

ALL

Min age

20 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: * Adult patients of 20 to 50 of age * Molars teeth * Medically free * Vital teeth * Males or females * one or cusps affected * Patient consent * Good oral hygiene (plaque index 0 or 1) * Absence of parafunctional habits. * No abscess Exclusion Criteria: * Xerostomia and bruxism. * Endodontically treated teeth * Systematic disease * Extremely poor oral hygiene sever or chronic periodontitis. * Pregnant and lactating women. * No subgingival margin * Allergic to used materials * Patient are not present during recalls .

Primary outcome measure(s)

Occlusal Wear — T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months
0 = No visible wear 1. = Slight wear, no effect on function 2. = Moderate wear, slight anatomical loss 3. = Severe wear needing intervention
Fracture Resistance — T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months
1. = Restoration fully intact 2. = Partially fractured but retained 3. = Completely fractured or lost
Caries Recurrence — T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months
0 = No recurrent caries at restoration margin 1 = Recurrent caries present and continuous with margin

Trial sites (1)

Facility	City	Region	Status
Future university in egypt	New Cairo	Cairo Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612462 on ClinicalTrials.gov ↗ ← All trials in Egypt