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The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02217098
Acronym
ARTUSP
Enrollment
530
Registered
2014-08-15
Start date
2014-07-31
Completion date
2018-09-10
Last updated
2018-11-21

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

Conditions

Caries Involving Multiple Surfaces of Tooth, Dental Caries Extending Into Dentine, Dental Caries on Chewing Surface of Tooth

Keywords

ART, Occlusal, Occlusoproximal, Primary teeth

Brief summary

The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions. This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.

Detailed description

The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions. This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected, 300 patients with one occlusal carie lesion and 300 different patients with occlusal proximal cavities. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research. The remaining carious lesions will be also be treated. The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity. So, the stratum of the study is OP and O. So, one randomization list will be performed for occlusal cavities and another randomization list will be used for occlusal proximal cavities. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.

Interventions

PROCEDUREGIC Restorations

Restorations using Glass Ionomer Cement

PROCEDURECarbomer Restorations

Restorations using Glass Carbomer

PROCEDURECompomer Restorations

Restorations using Compomer

Sponsors

Academic Centre for Dentistry in Amsterdam
CollaboratorOTHER
Daniela Prócida Raggio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria for the patient: * Healthy children, age: 4-8 years * At least one occlusal or proximal carious lesion in primary molar involving dentin * Cooperative behavior * Presence of antagonist of the tooth Inclusion criteria for the tooth: * Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm * Absence of tooth mobility and abscess or fistula near to the selected tooth

Exclusion criteria

* Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research.

Design outcomes

Primary

MeasureTime frameDescription
Survival rate (longevity) of ART restorations using differents materials6, 12, 24 and 36 months follow-upThe null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and occlusoproximal caries in primary molars with ART under field conditions.

Secondary

MeasureTime frame
Association between survival and DMFT (caries experience)6, 12, 24 and 36 months follow-up
Association between survival and occlusal contact after restoration6, 12, 24 and 36 months follow-up
Association between survival and gender6, 12, 24 and 36 months follow-up
Cost-effectiveness of the 3 materials and their association with survival rate6, 12, 24 and 36 months follow-up
Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)6, 12, 24 and 36 months follow-up
Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)6, 12, 24 and 36 months follow-up

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026