Evaluation of Ion Releasing Hybrid Restorative Material

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: Conventional resin composite; Other: Activa Presto; Other: Giomer

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical evaluation according to USPHS criteria	Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: 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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 10, 2021
• Primary Completion (ANTICIPATED): October 10, 2022
• Study Completion (ANTICIPATED): October 30, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (ACTUAL): April 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 1994

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No