Evaluation of Ion Releasing Hybrid Restorative Material

NCT04854655 | Unknown

• 1 other identifier: 1994
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Mechanical evaluation according to USPHS criteria

  Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness

  1 year

Secondary Outcomes (1)

• : Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria

  1 year

Study Arms (3)

Control

ACTIVE COMPARATOR

Conventional resin composite

Other: Conventional resin composite

Intervention 1

EXPERIMENTAL

Activa Presto

Other: Activa Presto

Intervention 2

EXPERIMENTAL

Giomer

Other: Giomer

Interventions

Conventional resin composite OTHER

nanofilled resin composite

Control

Activa Presto OTHER

calcium and phosphate hybrid material

Intervention 1

Giomer OTHER

fluoride releasing hybrid material

Intervention 2

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Faculty of Dentistry

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: October 10, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 30, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09