Clinical performance of high viscosity glass ionomer compared to amalgam restorations in patients with disabilities: 26 month evaluation randomized controlled trial.
- Conditions
- People/persons with disabilitiesMental Health - Other mental health disordersOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonDental Caries
- Registration Number
- ACTRN12621001668897
- Lead Sponsor
- School of dentistry, Universidad de Chile,
- Brief Summary
Research question: How is the clinical performance of high-density glass ionomers compared to amalgam restorations on occlusal lesions in patients with disabilities at 3, 12 and 26 months after treatment? Participant characteristics: 77 people with an impairment or disability that allows adaptation measures in dental care, age from 12 to 59 years, with occlusal caries lesions on two molars of opposite arches were randomly assigned Equia FIL GC high-density glass ionomer as intervention and Amalgam Nu Alloy as control Key results: To assess clinical performance of restorations we used Modified USPHS /Ryge clinical criteria. That includes as clinical parameters: Marginal adaptation, anatomic form, surface roughness, secondary caries, restoration luster and marginal staining. And considers ALPHA values when the restoration is in excellent condition on specific parameters and it is expected to last for a long time Preliminar results with statistical significance at 3 months after treatment: - Amalgam restorations only showed decrease in “Marginal adaptation” parameter. - Glass ionomer showed better values on “Anatomic form” and worse values on “Surface roughness” and “Marginal adaptation” - In “Restoration luster” and “Anatomic form” glass ionomers showed more ALPHA values than Amalgam restorations Limitations: Study follow-up time
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 73
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,
- Adverse medical history,
- People with severe or potential behavioral problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method