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Clinical performance of high viscosity glass ionomer compared to amalgam restorations in patients with disabilities: 26 month evaluation randomized controlled trial.

Clinical performance of Equia FIL GC® high-density glass ionomer compared to Nu Alloy® amalgam restorations in patients with disabilities with symptomless caries: 26 month evaluation randomized controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001668897
Enrollment
73
Registered
2021-12-03
Start date
2018-05-31
Completion date
2018-07-03
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To assess the clinical performance of high-density glass ionomer compared to amalgam restorations on occlusal lesions in patients with disabilities. Null hypothesis was that there would be no difference in the clinical performance between the restorative systems. Methodology: Two-arm split mouth randomized controlled clinical trial design. Patients with occlusal caries lesions on two molars of opposite arches were randomly assigned. A total of 77 patients were included, completing a total of 154 restorations. After 3, 18 y 26 months the restorations were evaluated considerating Modified USPHS/Ryge clinical.

Interventions

In people with disabilities who had occlusal caries lesions on two molars of opposite arches were randomly assigned as intervention and control. INTERVENTION: Restorations of Equia FIL GC® high-density glass ionomer. - Clínical procedure: caries removal, then the enamel and dentin were conditioned with 20% polyacrylic acid for 20 seconds, after mixted we injected the material immediately to the cavity and contoured with a hand instrument. When the material was set (approximately in 2.5 min),

In people with disabilities who had occlusal caries lesions on two molars of opposite arches were randomly assigned as intervention and control. INTERVENTION: Restorations of Equia FIL GC® high-density glass ionomer. - Clínical procedure: caries removal, then the enamel and dentin were conditioned with 20% polyacrylic acid for 20 seconds, after mixted we injected the material immediately to the cavity and contoured with a hand instrument. When the material was set (approximately in 2.5 min), restoration was finished with ultrafine diamond burs and polished with abrasive discs. Then, the coating material (EQUIA Coat) was applied with a micro brush to the surface of the restoration and irradiated for 20 seconds and finally occlusion check. - The treatment was performed by calibrated and trained dentists in Special Care Dental Clinic of the University of Chile. - Approximate duration 30 - 40 minutes. - The intervention will be administered once only.

Sponsors

School of dentistry, Universidad de Chile,
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
12 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

- People with an impairment or disability that allows adaptation measures in dental care. - Age from 12 to 59 years. - People with permanent teeth who had ICDAS 4 or 5 occlusal caries lesions on two molars of opposite arches that require restorative treatment - teeth that were symptomless and vital,

Exclusion criteria

- Adverse medical history, - People with severe or potential behavioral problems.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026