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Completed

NCT Number: NCT02217098

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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry - Sao Paulo University

São Paulo, 05508-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GIC Restorations

Procedure

Restorations using Glass Ionomer Cement

Carbomer Restorations

Procedure

Restorations using Glass Carbomer

Compomer Restorations

Procedure

Restorations using Compomer

Primary outcomes

  1. Survival rate (longevity) of ART restorations using differents materials

    Time frame: 6, 12, 24 and 36 months follow-up

    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 occlusoproximal caries in primary molars with ART under field conditions.

Secondary outcomes

  1. Association between survival and gender

    Time frame: 6, 12, 24 and 36 months follow-up

  2. Association between survival and DMFT (caries experience)

    Time frame: 6, 12, 24 and 36 months follow-up

  3. Association between survival and occlusal contact after restoration

    Time frame: 6, 12, 24 and 36 months follow-up

  4. Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)

    Time frame: 6, 12, 24 and 36 months follow-up

  5. Cost-effectiveness of the 3 materials and their association with survival rate

    Time frame: 6, 12, 24 and 36 months follow-up

  6. Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)

    Time frame: 6, 12, 24 and 36 months follow-up

Sponsors and collaborators

Lead sponsor

Daniela Prócida Raggio

Other

Collaborators

  • Academic Centre for Dentistry in Amsterdam

Registry information

Acronym: ARTUSP

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Aug 15, 2014
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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