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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2jmbvt
Enrollment
Unknown
Registered
2016-07-07
Start date
2014-10-06
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

dental caries.

Interventions

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 restor
Procedure/surgery

Sponsors

Faculdade de Odontologia de Bauru, da Usp
Lead Sponsor
Faculdad de Odontologia Catolica de Córdoba
Collaborator
Faculdad San Martin de Porres
Collaborator
Faculdade de Ciências da Saúde da Universidade de Brasília
Collaborator

Eligibility

Age
4 Years to 44 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Argentina, Brazil, Peru

Contacts

Public ContactMaria Fidela Navarro

Faculdade de Odontologia de Bauru, da Usp

mflnavar@usp.br55-11 - 30914700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)