Evaluation of Ion Releasing Hybrid Restorative Material

Dental Caries Clinical Trial

Official title:

Evaluation of Calcium and Phosphate Releasing Hybrid Restorative Material and Fluoride Releasing Hybrid Restorative Material Versus the Conventional Resin Composite in Proximal Carious Lesions Over One Year Follow-up Using USPHS Criteria

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04854655
• Other study ID #: 1994
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 30, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Conventional resin composite
nanofilled resin composite
• Activa Presto
calcium and phosphate hybrid material
• Giomer
fluoride releasing hybrid material

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical evaluation according to USPHS criteria	Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness	1 year
Secondary	: Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria	Color match, marginal discoloration, and restoration color stability	1 year