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NCT Number: NCT07612462

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cusp Capping Bulk Fill Composite Cuspal Coverage Fracture Resistance Tooth Restoration

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future university in egypt

New Cairo, Cairo Governorate, 11835, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Beautifil Bulk Fill (Shofu Inc.)

Device

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.

Primary outcomes

  1. Occlusal Wear

    Time frame: T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months

    0 = No visible wear

    • = Slight wear, no effect on function
    • = Moderate wear, slight anatomical loss
    • = Severe wear needing intervention

  2. Fracture Resistance

    Time frame: T0: Baseline examination (1 week after restoration) T1: 6 months T2: 9 months T3: 12 months

    • = Restoration fully intact
    • = Partially fractured but retained
    • = Completely fractured or lost

  3. Caries Recurrence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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