Clinical performance of two types of dental restorations: atraumatic and conventional

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-2jmbvt
• Date of registration: 07/07/2016
• Prospective Registration: No
• Primary sponsor: Faculdade de Odontologia de Bauru, da Usp
• Public title: Clinical performance of two types of dental restorations: atraumatic and conventional
• Scientific title: Randomized clinical trial of Class II ART restorations in deciduous teeth, with and without proximal retentions, and in permanent teeth in comparison with composite resin
• Date of first enrolment: 06/10/2014
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-2jmbvt
• Study type: Intervention
• Study design: Interventional, multicenter, double-blind, randomized, parallel clinic treatment with 2 arms.
• Phase: N/A

Countries of recruitment

Argentina, Brazil, Peru

Contacts

• Name: Maria Fidela de Lima Navarro
• Affiliation: Faculdade de Odontologia de Bauru, da Usp

• Name: Maria Fidela de Lima Navarro
• Affiliation: Faculdade de Odontologia de Bauru, da Usp

Key inclusion & exclusion criteria

Inclusion criteria: For Hypothesis I the children aged between 4 and 7 year with good general health and having class II cavities in deciduous teeth without pulp involvement or pain will be included.
For Hypothesis II the children aged between 8 and 12year; adolescent and adult between 13 and 44 year with good general health and 1 until 4 class II cavities in permanent teeth without pulp involvement or pain will be included.
Exclusion criteria: For Hypothesis I the children presenting behavioral problems; teeth with signs of sepsis, mobility or paranormal occlusion habits and absence of contacts with opposing or neighboring teeth will be excluded.
For Hypothesis II the children; adolescents and adults presenting teeth with signs of sepsis; mobility; more than 4 class II cavities in permanent teeth or paranormal occlusion habits and absence of contacts with opposing or neighboring teeth will be excluded.

Age minimum: 4Y
Age maximum: 44Y
Gender: -

Health Condition(s) or Problem(s) studied

dental caries.

Intervention(s)

Procedure/surgery

The study is parallel group, in primary teeth, with a test group (ART restorations with proximal retention), and a control group (ART restorations without proximal retention) for a total of 147 restorations for each group involved. For that ART restorations will be made with or without additional retention using Equia glass ionomer cement.
For the permanent teeth , there will be a test group (ART restorations with proximal retention), and a control group (class II conventional composite resin restorations)in a total of 134 restorations for each stakeholder group. ART restorations with additional retention will be made for the test group and for the control group resin composite restorations will be made using the Z-350 XT resin.
For making additional retention grooves a spoon excavator number 3 ART SSWhite Kit, Duflex will be used on the buccal and lingual walls of the proximal boxes of ARt Class II restorations.

Primary Outcome(s)

For Hypothesis I there is no difference in the clinical performance of ART class II restorations in deciduous teeth with and without additional retentions. For Hypothesis II there is no difference in the clinical performance of ART class II restorations in permanent teeth with additional retentions in comparison with composite resin restorations.

The criteria for this evaluation will be the Atraumatic Restorative Treatment (ART) and the US Public Health Assessment System (USPHS) after six months and one year and two years and three years.

Secondary Outcome(s)

For Class II ART restorations after six months and one year and two years and three years there will be 95% restoration success.
For composite restorations class II after 6 months and 1 year and 2 years and 3 years there will be 97% restoration success.

In both cases the adopted evaluation criteria will be the Atraumatic Restorative Treatment (ART) and the US Public Health Assessment System (USPHS) after six months and one year and two years and three years.

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação de Amparo à Pesquisa do Estado de São Paulo

Secondary Sponsor(s)

Faculdade de Ciências da Saúde da Universidade de Brasília

Faculdad de Odontologia Catolica de Córdoba

Faculdad San Martin de Porres