Clinical Evaluation of Self-Adhesive Bulk-Fill Composite Versus Conventional Nano-hybrid Composite in Cervical Cavities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMisr International University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Teeth showing signs of pulpitis or periapical pathosis.

Patients older than 60 years.

Patients younger than 18 years old.

Pregnant women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-Adhesive Bulkfill Composite (Surefil One)

    Combination product

    It is a new self-adhesive bulkfill composite that requires no previous adhesive steps.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Self-Adhesive Bulkfill Composite RestorationExperimental treatment 1 intervention
Group B: Nano-hybrid CompositeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical efficacy of the self-adhesive bulkfil composite in comparison to conventional composite

Modified USPHS Criteria Alpha(A) Bravo(B) Charlie(C)

Time frame
Six months

Secondary outcomes

1

Patient's Satisfaction of the final restorations

Visual Analogue Scale (VAS). A scale 0-10; 0 - Extremely unsatisfactory 5 - Neutral 10 - Extremely satisfactory

Time frame
Six Months.

Other outcomes

Sponsors and contacts

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