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

Dental Restoration Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03771196
• Other study ID #: 7/12/2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: December 2022

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: Yehia H. Yehia
• Phone: +20 01225337792
• Email: yehiahafez[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Restoration Failure

Intervention

Other:
• Bioactive 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
• Resin-modified glass ionomer
Enhanced glass ionomer with acceptable mechanical properties and esthtic properties

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

o ALKHUDHAIRY FI & ZH, A. 2016. Comparison of Shear Bond Strength and Microleakage of Various Bulk-fill Bioactive Dentin substitutes: An in vitro study. J Contemp Dent Pract, 17. o B. RANJBAR OMIDI, F. F. N., H. DEHGHAN, P. TAMIZ, M. MOHAMMADI SAVADROODBARI, AND R. JABBARIAN, 2018. Microleakage of an Enhanced Resin-Modified Glass Ionomer Restorative Material in Primary Molars. Journal of Dentistry of Tehran University of Medical Sciences (jdt), 15. o BANSAL, R., BURGESS, J. & LAWSON, N. C. 2016. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent, 29, 171-4. o CROLL, T. P., BERG, J. H. & DONLY, K. J. 2015. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent, 36, 60-5. o GAROUSHI, S., VALLITTU, P. K. & LASSILA, L. 2018. Characterization of fluoride releasing restorative dental materials. Dent Mater J, 37, 293-300. o HICKEL, R., PESCHKE, A., TYAS, M., MJOR, I., BAYNE, S., PETERS, M., HILLER, K. A., RANDALL, R., VANHERLE, G. & HEINTZE, S. D. 2010. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent, 12, 259-72. o MICHOU, S., LARSEN, L., BENETTI, A. R. & PEUTZFELDT, A. 2018. Adhesion and marginal integrity of bioactive restorative materials. Dental Materials, 34, e11. o NAGI, S. M., MOHARAM, L. M. & EL HOSHY, A. Z. 2018. Fluoride release and recharge of enhanced resin modified glass ionomer at different time intervals. Future Dental Journal. o NEMATOLLAHI, H., BAGHERIAN, A., GHAZVINI, K., ESMAILY, H. & MEHR, M. A. 2017. Microbial microleakage assessment of class V cavities restored with different materials and techniques: A laboratory study. Dental research journal, 14, 344-350. o OWENS, B. M., PHEBUS, J. G. & JOHNSON, W. W. 2018. Evaluation of the marginal integrity of a bioactive restorative material. Gen Dent, 66, 32-36. o PAMEIJER, C. H., GARCIA-GODOY, F., MORROW, B. R. & JEFFERIES, S. R. 2015. Flexural strength and flexural_fatigue. J Clin Dent, 26, 5. o PERDIGAO, J., DUTRA-CORREA, M., SARACENI, S. H., CIARAMICOLI, M. T. & KIYAN, V. H. 2012. Randomized clinical trial of two resin-modified glass ionomer materials: 1-year results. Oper Dent, 37, 591-601.2016. Guideline on Restorative Dentistry. Pediatr Dent, 38, 250-262.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical performance using United State Public Health Service (USHPS)		Change from the baseline at 6 months and12 months