Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite

Cairo University (CU)

Status: Not yet enrolling

Conditions: Proximal Cavities of Posterior Teeth

Treatments: Procedure: class II restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT06859086

SELF- CURE BULK-FILL RESIN

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion criteria:

• Deciduous teeth; as the study is targeting only permanent teeth.
• Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
• Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
• Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
• Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
• Teeth with cervical caries; which can't be evaluated on periapical radiographs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia)

Experimental group

Description:

New (Stela, SDI Ltd, Australia) restorative Self-cure: using the stela primer then stela composite with no curing.

Treatment:

Procedure: class II restoration

Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein)

Active Comparator group

Description:

After selective etching of enamel and bonding, the bulk-fill composite resins are inserted then curing.

Treatment:

Procedure: class II restoration