Evaluation of Ion Releasing Hybrid Restorative Material

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04854655
Collaborator
(none)
45
3
12.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional resin composite
  • Other: Activa Presto
  • Other: Giomer
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 10, 2021
Anticipated Primary Completion Date :
Oct 10, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

Conventional resin composite

Other: Conventional resin composite
nanofilled resin composite

Experimental: Intervention 1

Activa Presto

Other: Activa Presto
calcium and phosphate hybrid material

Experimental: Intervention 2

Giomer

Other: Giomer
fluoride releasing hybrid material

Outcome Measures

Primary Outcome Measures

  1. Mechanical evaluation according to USPHS criteria [1 year]

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

Secondary Outcome Measures

  1. : 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nouran Osama El-Sayed Ahmed Abou El-Nour, Resident at Faculty of Dentistry, Cairo University
ClinicalTrials.gov Identifier:
NCT04854655
Other Study ID Numbers:
  • 1994
First Posted:
Apr 22, 2021
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021