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

Cairo University (CU)

Status: Invitation-only

Conditions: High Caries Risk Patients; Class V Dental Caries

Treatments: Device: Giomer

Study type: Interventional

Funder types: Other

Identifiers

NCT06736964

Ahmed abdul monsif

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Predicta

Experimental group

Description:

based on dual cure bulk fill bioactive restoration

Treatment:

Device: Giomer

Activa presto

Experimental group

Description:

based on Bio-glass reinforced glass Ionomer

Treatment:

Device: Giomer

Giomer

Active Comparator group

Description:

based on Pre-reacted glass ionomer (PRG)

Treatment:

Device: Giomer