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

NCT ID: NCT03771196

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Dental Restoration Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Bioactive Restorative Material

Intervention Type OTHER

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 (RMGI)

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.

Group Type ACTIVE_COMPARATOR

Resin-modified glass ionomer

Intervention Type OTHER

Enhanced glass ionomer with acceptable mechanical properties and esthtic properties

Interventions

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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

Intervention Type OTHER

Resin-modified glass ionomer

Enhanced glass ionomer with acceptable mechanical properties and esthtic properties

Intervention Type OTHER

Other Intervention Names

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Activa Bioactive RestorActiva Bioactive Restorativeative Fuji II lc

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yehia Hafez Yehia

Yehia Hafez Yehia

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yehia H. Yehia

Role: CONTACT

Phone: +20 01225337792

Email: [email protected]

Amira F. El-Zoughbi

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type BACKGROUND

Other Identifiers

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7/12/2018

Identifier Type: -

Identifier Source: org_study_id