Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control Trial

Not Applicable

• Conditions: Dental Restoration Failure
• Interventions: Other: Bioactive Restorative Material; Other: Resin-modified glass ionomer

• Registration Number: NCT03771196
• Lead Sponsor: Cairo University

Brief Summary

Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer (RMGI) in class V o will be evaluated over 12 months using United State Public Health Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations

Detailed Description

Recent developments in the province of material sciences, some novel materials require direct association with oral environment for renewal, recharging or enhancing of the constituents of the restoration to improve marginal integrity to decrease bacterial microleakage. Physical and chemical properties of dental restorations have been progressed such that individual components may exert a bioactive role in the prevention, remineralization, and restoration of active carious lesions.Fluoride containing restorative materials recently gained great attention. Fluoride decreases caries activity by being a bacteriostatic and by decreasing the solubility of enamel and dentin through its integration into tooth tissue to form fluoroapatite. Moreover, it aids to remineralize defected tooth structure after demineralization. conventional GICs and RMGICs are have high fluoride release and could be specified clinically to repair decayed non-biting areas in high caries risk patients.To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified GIs (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-07
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11
• Study Start: 2019-03
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cervical Class V carious lesions.
• Age 18-50 years.
• Co-operative patients approving to participate in the study.
• Pulp asymptomatic vital carious posterior teeth.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

• Systemic disease or severe medical complications.
• Allergic history concerning methacrylates
• Rampant caries
• Pregnancy
• Disabilities
• Heavy smoking; xerostomia
• Lack of compliance
• Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive-Restorative material	Bioactive Restorative Material	Activa Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.
Resin Modified Glass Ionomer (RMGI)	Resin-modified glass ionomer	Fuji II Lc, fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics a wear-resistant, self-adhesive, light-cured resin coating.

Primary Outcome Measures

Name	Time	Method
Change in the clinical performance using United State Public Health Service (USHPS)	Change from the baseline at 6 months and12 months