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
NCT ID: NCT06859086
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-04-30
2027-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia)
New (Stela, SDI Ltd, Australia) restorative Self-cure: using the stela primer then stela composite with no curing.
class 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.
Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein)
After selective etching of enamel and bonding, the bulk-fill composite resins are inserted then curing.
class 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.
Interventions
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class 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.
Eligibility Criteria
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Inclusion Criteria
* Able to tolerate necessary restorative procedures.
* Provide informed consent.
* Accepts the 18 months follow-up period.
* 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
* 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:
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Wafaa Marei Kakat
Principal Investigator
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SELF- CURE BULK-FILL RESIN
Identifier Type: -
Identifier Source: org_study_id
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