Evaluation of Ion Releasing Hybrid Restorative Material

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Giomer; Other: Conventional resin composite; Other: Activa Presto

• Registration Number: NCT04854655
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09
• Study Start: 2021-10-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 2	Giomer	Giomer
Control	Conventional resin composite	Conventional resin composite
Intervention 1	Activa Presto	Activa Presto

Primary Outcome Measures

Name	Time	Method
Mechanical evaluation according to USPHS criteria	1 year	Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness

Secondary Outcome Measures

Name	Time	Method
: Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria	1 year	Color match, marginal discoloration, and restoration color stability