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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03771196
Enrollment
30
Registered
2018-12-11
Start date
2019-03-31
Completion date
2022-12-31
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure

Keywords

Bioactive Restorative Material, ACTIVA Restorative, Resin Modified Glass Ionomer (RMGI), class V, Clinical perfomance

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.

Interventions

Enhanced glass ionomer with acceptable mechanical properties and esthtic properties

OTHERBioactive Restorative Material

enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Contacts

Primary ContactYehia H. Yehia
yehiahafez@dentistry.cu.edu.eg+20 01225337792
Backup ContactAmira F. El-Zoughbi
amfzh52@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026