NCT02856932

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

First QC Date

August 1, 2016

Last Update Submit

August 2, 2016

Conditions

Class I Cavities in High Caries Risk

Outcome Measures

Primary Outcomes (1)

  • Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)

    1 year

Study Arms (2)

Glass Ionomer with Glass Hybrid technology

EXPERIMENTAL

Intervention

Other: Glass ionomer with glass hybrid technology

Conventional high viscosity Glass Ionomer

ACTIVE COMPARATOR

Comparator

Other: Conventional high viscosity glass ionomer

Interventions

Conventional high viscosity glass ionomerOTHER

Dental restorative material

Also known as: GC EQUIA
Conventional high viscosity Glass Ionomer
Glass ionomer with glass hybrid technologyOTHER

Dental restorative material

Also known as: GC EQUIA Forte
Glass Ionomer with Glass Hybrid technology

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Disabilities.
  • Systemic diseases or severe medically compromised.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching or temporomandibular joint disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral and dental medicine, cairo university

Cairo, 11553, Egypt

Location

MeSH Terms

Interventions

glass ionomer

Central Study Contacts

Mohamed R El-Bialy, Assistant lecturer

CONTACT

+201202552666M.refaat.op@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 5, 2016

Primary Completion

September 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

EG(1)