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

NCT06859086 | Not Yet Recruiting

• 1 other identifier: SELF- CURE BULK-FILL RESIN
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Cavities of Posterior Teeth

Outcome Measures

Primary Outcomes (1)

• Marginal adaptation

  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.

  24 months

Secondary Outcomes (8)

• Marginal discoloration

  24 months

• Recurrent caries

  24 months

• Retention analysis

  24 months

• Surface roughness

  24 months

• Postoperative sensitivity

  24 months

Study Arms (2)

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

EXPERIMENTAL

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

Procedure: class II restoration

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

ACTIVE COMPARATOR

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

Procedure: class II restoration

Interventions

class II restoration PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Central Study Contacts

Wafaa Marei Kakat, Master Degree

CONTACT

00201554054804; wafaa.marei@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

EG (1)