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

Not Applicable

• Conditions: Dental Restoration Failure

• Registration Number: NCT03859284
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2020-06-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Primary Completion: 2021-02
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Change from the baseline at 6 months and12 months]	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

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Giza, Egypt