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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06924047
Enrollment
50
Registered
2025-04-11
Start date
2025-04-30
Completion date
2026-04-30
Last updated
2025-04-11

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

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

Keywords

occlusal caries

Brief summary

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.

Interventions

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

OTHEREverX Flow

Short fiber reinforced composite

Sponsors

Dalia Sameh Fawzi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
FractureT1: 1 week T2: 6months T3: 12 months1. 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

Secondary

MeasureTime frameDescription
Recurrent cariesT1: 1 week T2: 6months T3: 12 months1. 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.
Post operative sensitivityT1: 1 week T2: 6months T3: 12 months1. 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.

Contacts

Primary ContactDalia SA Fawzi, BDS
dr.daliasameh@gmail.com+201147984047

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026