Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions

Study Overview
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Brief Summary
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With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Detailed Description
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flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

Official Title
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Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial

Conditions
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Dental Restoration Failure

Intervention / Treatment
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* Other: flowable resin composite
* Other: self adhering flowable
* Other: self adhering flowable with adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with anterior cervical carious lesions. Pulp asymptomatic vital carious anterior teeth. Co-operative patients approving to participate in the trial. Exclusion Criteria: Pregnancy. Disabilities. Systemic disease or severe medical complications. Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Heavy smokers.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flowable resin-composite<br>3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites. other names: ''flowable composite '' | Other: flowable resin composite<br>* gold standard<br>* Other names: conventional flowable composite;|
| Experimental: self-adhering flowable<br>intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system | Other: self adhering flowable<br>* moist bonding self adhering flowable composite<br>* Other names: embrace wet bond;|
| Experimental: self-adhering flowable with adhesive<br>intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance | Other: self adhering flowable with adhesive<br>* moist bonding self adhering flowable composite with the aid of an adhesive system.<br>* Other names: embrace wet bond with adhesive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes | Biological properties (Postoperative hypersensitivity & tooth vitality, Recurrence of caries, erosion & abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral & general health). Esthetic properties (Surface luster, Staining (surface &margin),Color match & translucency & Esthetic anatomical form). Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour &wear (quantitatively & qualitatively), Proximal anatomical form(contact point &contour), Radiographic examination(when applicable) &Patient's view For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory & poor). Subscales will not be combined | Change from the baseline at 6 months and12 months] |