Proximal Caries Clinical Trial
Official title:
Clinical Evaluation of Organically Modified Ceramic Resin Composite Versus Conventional Bulkfill Resin Composite in Proximal Compound Posterior Restorations: Randomized Clinical
Verified date | December 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation FDI criteria.
Status | Not yet recruiting |
Enrollment | 22 |
Est. completion date | February 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients aging =18 years. - Patients with a high level of oral hygiene. - Patients having at least 1or 2 posterior teeth in occlusion. - Patients with good likelihood of recall availability. Tooth inclusion: - Permanent premolars or molars. - Moderate to deep compound class II cavities. - Primary carious lesions. - Vital with positive reaction to cold thermal stimulus. - Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth. Exclusion Criteria: - Participants with general/systemic illness. - Pregnant or lactating females. - Concomitant participation in another research study. - Inability to comply with study procedures. - Heavy bruxism habits. - Last experience with allergic reactions against any components of the used materials. - Patients receiving orthodontic treatment. Tooth exclusion: - Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. - Non-vital teeth. - Secondary carious lesions. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | secondary caries | Biological properties: visually inspected and evaluated using FDI probe and then classified accordingly
Clinically excellent / very good no caries Clinically good small & localized Clinically sufficient /satisfactory large area of demineralization Clinically unsatisfactory (but reparable) caries with cavitation Clinically poor (replacement necessary) Deep caries or exposed dentine |
24 months | |
Primary | Fracture | Fracture of material visually inspected and evaluated using FDI probe and then classified accordingly
clinically excellent/very good: No fractures /cracks. Clinically good: Small hairline crack. Clinically sufficient /satisfactory(minor shortcomings, no unacceptable effects but not adjustable w/or damage to the tooth):Two or more or larger hairline cracks and/or material chipfracture no affecting the marginal integrity or approximal contact. Clinically unsatisfactory /(but reparable):Material chip fractures which damage marginal quality or Bulk fractures with partial loss(less than half of the restoration). ditching or marginal fractures. Clinically poor (replacement necessary): (Partial or complete) loss of restoration or multiple fractures. |
24 months | |
Secondary | color match | Esthetic visually inspected and evaluated using FDI probe and then classified
clinically excellent/very good Luster comparable to enamel,& , no difference in shade Clinically good Slightly dull, & minor shade deviation Clinically sufficient /satisfactory. Dull surface & distinct shade deviation Clinically unsatisfactory /(but reparable) Rough surface, & localized shade deviation that can be repaired Clinically poor (replacement necessary): Very rough & un acceptable shade need replacement |
24 months |
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