Dental Caries
Conditions
Brief summary
The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.
Interventions
PROCEDUREHighly viscous glass ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
PROCEDURELow shrinkage Flowable Composite (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
PROCEDUREResin Modified Glass Ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
PROCEDUREBioactive Ionic Resin (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health * Good oral hygiene * Patient aging 20-40 y * Patients with proximal deep carious lesion * International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically. * Normal response to a vitality test.
Exclusion criteria
* poor general health * poor oral hygiene * Teeth would need direct pulp capping * Teeth act as abutment for fixed or removable prosthesis. * patients with excessive parafunctional habits * Patient potentially unable to be compliant to recall visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingiva | three year follow up | Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva |
| Modified World Dental Federation (FDI) clinical Criteria | three year follow up | 1. Functional Properties of restorations: 1. Fracture of material and retention 2. Marginal adaptation 3. Radiographic examination 2. Biological Properties of restorations 1. Postoperative (hyper-sensitivity and tooth vitality 2. Recurrence of caries 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal Response 5. Adjacent mucosa Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor. Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated |
Countries
Egypt
Outcome results
None listed