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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
GIC Restorations
Carbomer Restorations
Compomer Restorations
Sponsored by
Daniela Prócida Raggio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Involving Multiple Surfaces of Tooth focused on measuring ART, Occlusal, Occlusoproximal, Primary teeth

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Dentistry - Sao Paulo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

GIC Restorations

Compomer Restorations

Carbomer Restorations

Arm Description

Restorations using Glass Ionomer Cement

Restorations using Compomer

Restorations using Glass Carbomer

Outcomes

Primary Outcome Measures

Survival rate (longevity) of ART restorations using differents materials
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 Outcome Measures

Association between survival and gender
Association between survival and DMFT (caries experience)
Association between survival and occlusal contact after restoration
Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)
Cost-effectiveness of the 3 materials and their association with survival rate
Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)

Full Information

First Posted
May 21, 2014
Last Updated
November 19, 2018
Sponsor
Daniela Prócida Raggio
Collaborators
Academic Centre for Dentistry in Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT02217098
Brief Title
The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
Acronym
ARTUSP
Official Title
The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Prócida Raggio
Collaborators
Academic Centre for Dentistry in Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Involving Multiple Surfaces of Tooth, Dental Caries on Chewing Surface of Tooth, Dental Caries Extending Into Dentine
Keywords
ART, Occlusal, Occlusoproximal, Primary teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIC Restorations
Arm Type
Active Comparator
Arm Description
Restorations using Glass Ionomer Cement
Arm Title
Compomer Restorations
Arm Type
Experimental
Arm Description
Restorations using Compomer
Arm Title
Carbomer Restorations
Arm Type
Experimental
Arm Description
Restorations using Glass Carbomer
Intervention Type
Procedure
Intervention Name(s)
GIC Restorations
Intervention Description
Restorations using Glass Ionomer Cement
Intervention Type
Procedure
Intervention Name(s)
Carbomer Restorations
Intervention Description
Restorations using Glass Carbomer
Intervention Type
Procedure
Intervention Name(s)
Compomer Restorations
Intervention Description
Restorations using Compomer
Primary Outcome Measure Information:
Title
Survival rate (longevity) of ART restorations using differents materials
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 occlusoproximal caries in primary molars with ART under field conditions.
Time Frame
6, 12, 24 and 36 months follow-up
Secondary Outcome Measure Information:
Title
Association between survival and gender
Time Frame
6, 12, 24 and 36 months follow-up
Title
Association between survival and DMFT (caries experience)
Time Frame
6, 12, 24 and 36 months follow-up
Title
Association between survival and occlusal contact after restoration
Time Frame
6, 12, 24 and 36 months follow-up
Title
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
Title
Cost-effectiveness of the 3 materials and their association with survival rate
Time Frame
6, 12, 24 and 36 months follow-up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela P Raggio, Professor
Organizational Affiliation
Universidade de Sao Paulo - Faculdade de Odontologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabel O Costa, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
School of Dentistry - Sao Paulo University
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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derived

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

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