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NCT Number: NCT06924047

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

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.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged (20-50)
  • Medically free
  • Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
  • Patients accepting to participate in the study.
  • Teeth of normal appearance and morphology
  • Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.

Exclusion criteria

  • Patients <20 and >50.
  • Teeth with proximal lesions.
  • Patients with bad oral hygiene (Plaque index >2).
  • Systematic disease that may interfere with the study.
  • Patients with xerostomia.
  • Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
  • Patients undergoing or will start orthodontic treatment.
  • Pregnancy.
  • Teeth with signs or symptoms of irreversible pulpitis.
  • Non-vital, fractured or cracked teeth.
  • Teeth with secondary caries.
  • Periodontally compromised teeth.

Treatment and study plan

Beautifil Flow Plus X

Other

Shofu's Beautifil Flow Plus X F00 a advanced bioactive injectable composite

EverX Flow

Other

Short fiber reinforced composite

Primary outcomes

  1. Fracture

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

    • Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying.
    • Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying
    • Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying
    • Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention
    • Clinically poor (entirely insufficient): Generalized severe deficiencies

Secondary outcomes

  1. Recurrent caries

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

    • Clinically excellent/very good (sufficient): No caries/demineralization at the restoration margin detectable after air drying.
    • Clinically good (sufficient): First visible signs of a non-cavitated caries lesion at the restoration margin detectable after air drying.
    • Clinically satisfactory (sufficient): Established, non- cavitated caries lesion or microcavity at the restoration margin detectable without air drying.
    • Clinically unsatisfactory (partially insufficient):

    Localized dentin cavity at the restoration margin.

    • Clinically poor (entirely insufficient): Extensive dentin cavity at the restoration margin.

  2. Post operative sensitivity

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia SA Fawzi, BDS

CONTACT

[email protected]

+201147984047

Sponsors and collaborators

Lead sponsor

Dalia Sameh Fawzi

Other

Registry information

Official study title

The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

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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