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

D

Dalia Sameh Fawzi

Status

Not yet enrolling

Conditions

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

Treatments

Other: Beautifil Flow Plus X
Other: EverX Flow

Study type

Interventional

Funder types

Other

Identifiers

NCT06924047
Restoring Deep Occlusal Cavity

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Bioactive injectable composite
Active Comparator group
Description:
bioactive injectable composite placed as a dentine substitute
Treatment:
Other: Beautifil Flow Plus X
Short fiber reinforced composite
Active Comparator group
Description:
Short fiber reinforced composite added as a dentine substitute
Treatment:
Other: EverX Flow

Trial contacts and locations

0

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Central trial contact

Dalia SA Fawzi, BDS

Data sourced from clinicaltrials.gov

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