Evaluation of Ion Releasing Hybrid Restorative Material

NCT ID: NCT04854655

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2022-10-30

Brief Summary

Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.

Detailed Description

3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

Conventional resin composite

Group Type: ACTIVE_COMPARATOR

Conventional resin composite

Intervention Type: OTHER

nanofilled resin composite

Intervention 1

Activa Presto

Group Type: EXPERIMENTAL

Activa Presto

Intervention Type: OTHER

calcium and phosphate hybrid material

Intervention 2

Giomer

Group Type: EXPERIMENTAL

Giomer

Intervention Type: OTHER

fluoride releasing hybrid material

Interventions

Conventional resin composite

nanofilled resin composite

Intervention Type: OTHER

Activa Presto

calcium and phosphate hybrid material

Intervention Type: OTHER

Giomer

fluoride releasing hybrid material

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient-related criteria:

• Patients consulting in one of the outpatient clinics listed above.
• Patients can tolerate necessary restorative procedures.
• Provide informed consent.
• Patients accept the one year follow-up period.
• Patients are within middle age group (25-40years).
• Cooperative patients.
• Patients don't have any medically compromised conditions.

Tooth related criteria:

• Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
• Teeth should have contact with the adjacent teeth.
• Teeth are vital according to pulp-sensitivity tests.
• No active gingival or periodontal conditions.

Exclusion Criteria

• • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.

• Pregnant women; as radiographs are prohibited.
• Allergic Patients to any of the restorative materials, including anesthetics.
• Uncooperative patients will not follow the instructions or attend the appointments.

Tooth related criteria:

• Retained deciduous teeth; as the research 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) indicating irreversible pulpitis.
• Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Osama El-Sayed Ahmed Abou El-Nour

Resident at Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1994

Identifier Type: -

Identifier Source: org_study_id