Clinical trial
Clinical Evaluation of Self-Adhesive Bulk-Fill Composite Versus Conventional Nano-hybrid Composite in Cervical Cavities - A Randomized Controlled Clinical Trial
Name
MIU-IRB-2223-177
Description
The aim of this randomized clinical trial is to compare the six months clinical performance of the self-adhesive bulk-fill composite with the conventional nano-hybrid composite in the cervical lesions of teeth in the esthetic zone. In addition, to evaluate patient's satisfaction towards the self-adhesive bulk-fill material and its total operatory time.
Trial arms
Trial start
2023-03-14
Estimated PCD
2024-06-20
Trial end
2024-07-30
Status
Recruiting
Treatment
Self-Adhesive Bulkfill Composite (Surefil One)
It is a new self-adhesive bulkfill composite that requires no previous adhesive steps.
Arms:
Nano-hybrid Composite, Self-Adhesive Bulkfill Composite Restoration
Size
54
Primary endpoint
Clinical efficacy of the self-adhesive bulkfil composite in comparison to conventional composite
Six months
Eligibility criteria
Inclusion Criteria:
* Cervical lesions.
* Cervical lesions of at least one mm depth; to include enamel and dentin.
* Cervical lesions of not more than 3 mm in depth.
* Male or female genders.
* Medically free patients.
* Normal occlusion.
* Healthy Gingiva
Exclusion Criteria:
* Teeth showing signs of pulpitis or periapical pathosis.
* Patients older than 60 years.
* Patients younger than 18 years old.
* Pregnant women.
* Patients with history of allergy to resin.
* Patients with disabilities.
* Carious cervical lesions extending to proximal surfaces.
* Carious cervical lesions on the palatal/lingual surfaces.
* Teeth with root caries.
* Endodontically treated teeth.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}
Updated at
2024-05-02
1 organization
1 product
1 indication
Organization
Misr International UniversityIndication
Dental caries