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

Class I Cavities in High Caries Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02856932
• Other study ID #: CEBD-CU-2016-08-178
• Status: Not yet recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 2, 2016

Study information

• Verified date: August 2016
• Source: Cairo University
• Contact: Mohamed R El-Bialy, Assistant lecturer
• Phone: +201202552666
• Email: M.refaat.op[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. primary completion date: September 2018
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Class I Cavities in High Caries Risk

Intervention

Other:
• Conventional high viscosity glass ionomer
Dental restorative material
• Glass ionomer with glass hybrid technology
Dental restorative material

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine, cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)		1 year