Dental Restoration Failure
Conditions
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.
Interventions
gold standard
OTHERself adhering flowable
moist bonding self adhering flowable composite
OTHERself adhering flowable with adhesive
moist bonding self adhering flowable composite with the aid of an adhesive system.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary Contactmona mounir, msc
Backup Contacthussein gomaa, PhD
Outcome results
None listed