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Investigation of Glass Carbomer Performance

12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04127929
Enrollment
36
Registered
2019-10-16
Start date
2017-09-09
Completion date
2018-09-10
Last updated
2019-10-16

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

Conditions

Dental Caries

Keywords

glass ionomer, composite, clinical

Brief summary

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.

Detailed description

The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material. In this study, total of 100 (46 class I, 54 class II) restorations were performed in 36 patients. All cavities were prepared conventionally. Half of the restorations were restored with nano composite resin (Tokuyama Estelite, Tokuyama Dental, Japan) and the other half were restored with glass carbomer material (GCP Dental, The Netherlands). Rubber-dam was used for isolation. Before the replacement of composite restorations, enamel edges were etched according to selective etching method. Then universal adhesive system was applied. Composite resin was applied to the cavity in 2 mm layers by incramental technique. Glass carbomer was placed with bulk technique by applying finger pressure with surface covering. Composite restorations were polymerized with LED light curing unit. Glass carbomer restorations were cured its own special curing unit. Restorations were evaluated with modified USPHS criteria at the end of the first week, 6 months and 12 months. Data were analyzed using Fisher's Exact Chi-Square test, Fisher Freeman Halton Test and Continuity (Yates) Correction. Wilcoxon sign test was used for intra-group comparisons of the parameters. Statistically significance was evaluated at p \<0.05.

Interventions

OTHERRestoration of cavities using glass carbomer material (GCP Dental)

Detection of caries then restoration of cavities

OTHERRestoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)

Detection of caries then restoration of cavities

Sponsors

Bezmialem Vakif University
CollaboratorOTHER
Okan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

1. 20-25 years of age 2. No systemic diseases 3. Presence of molar / premolar teeth with occlusal and / or interface caries 4. Lack of parafunctional habits such as clenching and grinding of teeth 5. Lack of cooperation problems 6. Accepted regular visits -

Exclusion criteria

* 1-Any endodontic treatment or withdrawal indications (abscess, swelling and fistula complaints, palpation and percussion pain, spontaneous or night pain) 2- Teeth with congenital developmental defect 3- Teeth with pathological mobility 4- Teeth which do not have normal occlusion due to skeletal or pathological reasons 5- Lack of contact or opposite teeth

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of criterias1 weekIn this clinical study, the restorations were evaluated.Restorations were scored. using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.End of the one-week there was no significant differences between restorative materials for all evaluation criterias, were mentioned in summary.

Secondary

MeasureTime frameDescription
Evaluation of criterias6-monthsIn this clinical study, the restorations were evaluated.Restorations were scored using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.2. When the restorations made using glass carbomer filling materials were evaluated in terms of anatomic form, retention, and marginal adaptation, restorations with Charlie score in the 6-months

Other

MeasureTime frameDescription
Evaluations of criterias12-monthsIn this clinical study, the restorations were evaluated.Restorations were scored using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.2. When the restorations made using glass carbomer filling materials were evaluated in terms of anatomic form, retention, and marginal adaptation, restorations with Charlie score in the 12-months.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026