Proximal Cavities of Posterior Teeth
Conditions
Brief summary
the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.
Detailed description
Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence. For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up
Interventions
PROCEDUREclass II restoration
A class II cavity will be prepared after local anesthesia has been given as requierd . Rubber dam isolation will be done. Sectional matricing and wedging will be done. Followed by placement of restorative material according to the randomization sequence.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Patient-related criteria: Inclusion criteria: * Patients consulting in one of the outpatient clinics listed above. * Able to tolerate necessary restorative procedures. * Provide informed consent. * Accepts the 18 months follow-up period.
Exclusion criteria
* Medically compromised patients, as they will not be able to attend multiple appointments or may require special management. * Pregnant women; as radiographs cannot be taken for them. * Allergy to any of the restorative materials, including anesthetics. * Uncooperative patients, will not abide by the instructions or attend the appointments. Tooth related criteria: Inclusion criteria: * Teeth with primary proximal carious lesions. * Teeth are vital according to pulp-sensitivity tests. * Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent caries | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement. |
| Retention analysis | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement. |
| Surface roughness | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
| Marginal discoloration | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
| Anatomic form | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
| Proximal contact | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
| Color match | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement. |
| Postoperative sensitivity | 24 months | The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement. |
Countries
Egypt
Contacts
Primary ContactWafaa Marei Kakat, Master Degree
Outcome results
None listed