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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorDalia Sameh Fawzi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients <20 and >50.

Teeth with proximal lesions.

Patients with bad oral hygiene (Plaque index >2).

Systematic disease that may interfere with the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beautifil Flow Plus X

    Other intervention

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

  • EverX Flow

    Other intervention

    Short fiber reinforced composite

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Bioactive injectable compositeActive comparator 1 intervention
Group B: Short fiber reinforced compositeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fracture

1. Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying. 2. Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying 3. Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying 4. Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention 5. Clinically poor (entirely insufficient): Generalized severe deficiencies

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

Secondary outcomes

1

Recurrent caries

1. Clinically excellent/very good (sufficient): No caries/demineralization at the restoration margin detectable after air drying. 2. Clinically good (sufficient): First visible signs of a non-cavitated caries lesion at the restoration margin detectable after air drying. 3. Clinically satisfactory (sufficient): Established, non- cavitated caries lesion or microcavity at the restoration margin detectable without air drying. 4. Clinically unsatisfactory (partially insufficient): Localized dentin cavity at the restoration margin. 5. Clinically poor (entirely insufficient): Extensive dentin cavity at the restoration margin.

Time frame
T1: 1 week T2: 6months T3: 12 months
2

Post operative sensitivity

1. Clinically excellent/very good (sufficient): No Postoperative hypersensitivity. 2. Clinically good (sufficient): Minor postoperative hypersensitivity. 3. Clinically satisfactory (sufficient) Distinct "moderate" postoperative hypersensitivity. 4. Clinically unsatisfactory (partially insufficient): Severe "persistent" postoperative hypersensitivity. 5. Clinically poor (entirely insufficient): Extreme postoperative hypersensitivity "Irreversible pulpitis".

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dalia Sameh Fawzi

Lead sponsor

Future University in Egypt

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: