Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients

NCT ID: NCT06736964

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-04-01

Brief Summary

The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.

Reducing the incidence of recurrent caries is the primary outcome

Detailed Description

Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .

Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .

This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.

Conditions

Class V Dental Caries; High Caries Risk Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Predicta

based on dual cure bulk fill bioactive restoration

Group Type: EXPERIMENTAL

Giomer

Intervention Type: DEVICE

based on Pre-reacted glass ionomer (PRG)

Activa presto

based on Bio-glass reinforced glass Ionomer

Group Type: EXPERIMENTAL

Giomer

Intervention Type: DEVICE

based on Pre-reacted glass ionomer (PRG)

Giomer

based on Pre-reacted glass ionomer (PRG)

Group Type: ACTIVE_COMPARATOR

Giomer

Intervention Type: DEVICE

based on Pre-reacted glass ionomer (PRG)

Interventions

Giomer

based on Pre-reacted glass ionomer (PRG)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient age range from 25-45 year.
• High risk caries.
• Patients required at least a couple of Class V restorations.
• The depth of lesion should be(1.5- 2 mm) .
• The patient should have good general health

Exclusion Criteria

• Poor oral hygiene.
• Sever or chronic periodontal disease or Bruxism.
• Severe tooth sensitivity.
• Non-vital or fracture or cracked teeth.
• Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
• pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yehia Hafez Yehia

Lecturer of Conservative Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf Nasr, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Dentistry Cairo University, Cairo, Egypt

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Ahmed abdul monsif

Identifier Type: -

Identifier Source: org_study_id