Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients

NCT ID: NCT02856932

Last Updated: 2016-08-05

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

31 participants

Study Classification

INTERVENTIONAL

Brief Summary

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PICOTS:

P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.

T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer

Detailed Description

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Conditions

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Class I Cavities in High Caries Risk

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Glass Ionomer with Glass Hybrid technology

Intervention

Group Type EXPERIMENTAL

Glass ionomer with glass hybrid technology

Intervention Type OTHER

Dental restorative material

Conventional high viscosity Glass Ionomer

Comparator

Group Type ACTIVE_COMPARATOR

Conventional high viscosity glass ionomer

Intervention Type OTHER

Dental restorative material

Interventions

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Conventional high viscosity glass ionomer

Dental restorative material

Intervention Type OTHER

Glass ionomer with glass hybrid technology

Dental restorative material

Intervention Type OTHER

Other Intervention Names

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GC EQUIA GC EQUIA Forte

Eligibility Criteria

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Inclusion Criteria

* Bilateral class I carious lesions in their occlusal pits and fissures.
* High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
* Co-operative patients approving to participate in the trial.

Exclusion Criteria

* Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
* Evidence of severe bruxism, clenching or temporomandibular joint disorders
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Refaat El-Bialy

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of oral and dental medicine, cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed R El-Bialy, Assistant lecturer

Role: CONTACT

+201202552666

Facility Contacts

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Amira F El-Zoghby, Professor

Role: primary

+201222106620

Ahmed A El-Zohairy, Associate professor

Role: backup

+201227848002

Other Identifiers

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CEBD-CU-2016-08-178

Identifier Type: -

Identifier Source: org_study_id

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