Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001668897
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
3/12/2021
Date last updated
3/12/2021
Date data sharing statement initially provided
3/12/2021
Date results information initially provided
3/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical performance of high viscosity glass ionomer compared to amalgam restorations in patients with disabilities: 26 month evaluation randomized controlled trial.
Scientific title
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.
Secondary ID [1] 302926 0
‘Nil known’
Universal Trial Number (UTN)
U1111-1262-1449
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People/persons with disabilities 320582 0
Dental Caries 320583 0
Condition category
Condition code
Oral and Gastrointestinal 318441 318441 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 318442 318442 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319648 0
Treatment: Other
Intervention code [2] 319649 0
Treatment: Devices
Comparator / control treatment
In people with disabilities who had occlusal caries lesions on two molars of opposite arches were randomly assigned as intervention and control.

CONTROL: Restorations of Amalgam Nu Alloy®
- Clínical procedure: caries removal, previous lining glass ionomer dentine protector is applied. The material is taken to the cavity and it is condensed and burnished (4 - 5 minutes), the amalgam is carved together with burnishing (6-8 minutes), check occlusion and burnishing.
- 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.
Control group
Active

Outcomes
Primary outcome [1] 326496 0
Proportion of Equia FIL GC® high-density glass ionomer restorative system and Amalgam in the restoration of posterior teeth that present Alfa in accordance with the Modified USPHS /Ryge clinical criteria 3 months after treatment.

Modified USPHS /Ryge clinical criteria consider ALPHA a restorations in excellent condition, expected to last for a long time. Includes as clinical parameters:
a) Marginal adaptation: the explorer does not catch or has one way catch when drawn across the restoration/tooth interface.
b) Anatomic form: general contour of the restoration follows the contour of the tooth.
c) Surface roughness: restoration surface does not have any surface defects.
d) Secondary caries: there is no clinical diagnosis of caries.
e) Restoration luster: restoration surface is shiny and has an enamel-like, translucent appearance.
f) Marginal staining: not present.
Timepoint [1] 326496 0
3 months after treatment.
Primary outcome [2] 326497 0
Proportion of Equia FIL GC® high-density glass ionomer restorative system and Amalgam in the restoration of posterior teeth that present Alpha in accordance with the Modified USPHS /Ryge clinical criteria 18 months after treatment.

Timepoint [2] 326497 0
18 months after treatment.
Primary outcome [3] 326498 0
Proportion of Equia FIL GC® high-density glass ionomer restorative system and Amalgam in the restoration of posterior teeth that present Alpha in accordance with the Modified USPHS /Ryge clinical criteria 26 months after treatment.
Timepoint [3] 326498 0
26 months after treatment.
Secondary outcome [1] 391688 0
Evaluate clinical performance of Equia FIL GC® high-density glass ionomer restorative system in the restoration of posterior teeth compared with Amalgam 3, 18 and 26 months after treatment with Modified USPHS /Ryge clinical criteria.
Timepoint [1] 391688 0
3, 18, 26 months after treatment

Eligibility
Key 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,
Minimum age
12 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Adverse medical history,
- People with severe or potential behavioral problems.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Participants have lesions on two molars of opposite arches that require restorative treatment, and so receive both interventions at the same time, with the side that receives the intervention or comparator treatment randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated based in Gurgan study 2016, with a Confidence Interval of 95%, a Power of 80% and a 20% of over sampling for possible loss of follow-up.
Therefore, a total of 77 patients will be included in the study.

Data analysis:
To analyze the proportion of the study restorations according Modified USPHS /Ryge clinica criteria over the study period, Mann-Whitney non -parametric tests was used.
And to compare the performance restorative materials Wilcoxon signed rank test was used.
Statistical analysis was performed with SPSS15.0 software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2018
Date of last participant enrolment
Anticipated
Actual
3/07/2018
Date of last data collection
Anticipated
Actual
5/03/2021
Sample size
Target
77
Accrual to date
Final
73
Recruitment outside Australia
Country [1] 23451 0
Chile
State/province [1] 23451 0
Santiago

Funding & Sponsors
Funding source category [1] 307348 0
Government body
Name [1] 307348 0
ANID, Agencia Nacional de Investigación y Desarrollo.
Country [1] 307348 0
Chile
Primary sponsor type
University
Name
School of dentistry, Universidad de Chile,
Address
Olivos 943, Independencia, Región Metropolitana.8380544. Province Santiago
Country
Chile
Secondary sponsor category [1] 307987 0
Charities/Societies/Foundations
Name [1] 307987 0
Pequeño cottolengo
Address [1] 307987 0
Av. Don Orione 7306, Cerrillos, Santiago/ 9200423/ Province Santiago.
Country [1] 307987 0
Chile
Other collaborator category [1] 281647 0
Other
Name [1] 281647 0
Escuela de lenguaje Cecla
Address [1] 281647 0
Las Brisas 560, La Cisterna, Región Metropolitana/ 7980761/ Province Santiago.


Country [1] 281647 0
Chile
Other collaborator category [2] 281648 0
Charities/Societies/Foundations
Name [2] 281648 0
Hogar Dios con nosotros, Fundación Cristo Vive.
Address [2] 281648 0
José santos ossas 2840, Recoleta. Región metropolitana.8420000. Province Santiago.
Country [2] 281648 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307435 0
Committee of ethics in human beings of the Faculty of Medicine of the University of Chile.
Ethics committee address [1] 307435 0
Independencia 1027/ Independencia/ Región Metropolitana 8380453/Province Santiago.
Ethics committee country [1] 307435 0
Chile
Date submitted for ethics approval [1] 307435 0
27/03/2018
Approval date [1] 307435 0
09/05/2018
Ethics approval number [1] 307435 0

Summary
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.


Trial website
No
Trial related presentations / publications
No
Public notes
No

Contacts
Principal investigator
Name 107226 0
Prof Silvia Monsalves Bravo
Address 107226 0
School of dentistry, Universidad de Chile, Olivos 943, Independencia, Región Metropolitana.8380544. Province Santiago.
Country 107226 0
Chile
Phone 107226 0
+562 2978 1725
Fax 107226 0
Email 107226 0
[email protected]
Contact person for public queries
Name 107227 0
Prof Silvia Monsalves Bravo
Address 107227 0
School of dentistry, Universidad de Chile, Olivos 943, Independencia, Región Metropolitana.8380544. Province Santiago.
Country 107227 0
Chile
Phone 107227 0
+562 2978 1725
Fax 107227 0
Email 107227 0
[email protected]
Contact person for scientific queries
Name 107228 0
Prof Silvia Monsalves Bravo
Address 107228 0
School of dentistry, Universidad de Chile, Olivos 943, Independencia, Región Metropolitana.8380544. Province Santiago.
Country 107228 0
Chile
Phone 107228 0
+562 2978 1725
Fax 107228 0
Email 107228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Silvia Monsalves Bravo, [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10536Clinical study report  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.