Clinical trial NCT06924047: The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)
Official title: The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Class I Cavities in High Caries Risk
Class I Composite Restorations
Randomized Clinical Trial
Occlusal Caries
Fiber Reinforced Composite
Injectable Composite
Composite Restoration
Composite Resins
Keywords: occlusal caries
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fracture
timeFrame: T1: 1 week T2: 6months T3: 12 months
Secondary outcomes:
measure: Recurrent caries
timeFrame: T1: 1 week T2: 6months T3: 12 months
measure: Post operative sensitivity
timeFrame: T1: 1 week T2: 6months T3: 12 months
Other outcomes:
Locations:
Study officials:
References:
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