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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07612462
Enrollment
50
Registered
2026-05-28
Start date
2025-12-01
Completion date
2026-12-31
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bulk Fill Composite, Cuspal Coverage, Cusp Capping, Fracture Resistance, Tooth Restoration

Keywords

Cuspal Coverage

Brief 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.

Interventions

DEVICEBeautifil 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.

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Occlusal WearT0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months0 = No visible wear 1. = Slight wear, no effect on function 2. = Moderate wear, slight anatomical loss 3. = Severe wear needing intervention
Fracture ResistanceT0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months1. = Restoration fully intact 2. = Partially fractured but retained 3. = Completely fractured or lost
Caries RecurrenceT0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months0 = No recurrent caries at restoration margin 1 = Recurrent caries present and continuous with margin

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026