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Completed

NCT Number: NCT01924611

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination

AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal da Paraíba

João Pessoa, Paraíba, 58000-000, Brazil

About this study

To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Who can participate

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

Inclusion criteria

  • Children of both genders enrolled in school,
  • Children aged between 6 and 7 years,
  • having cavity with access to ART hand instruments,
  • cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
  • proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

Exclusion criteria

  • Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
  • Children out of the age range,

Treatment and study plan

Atraumatic Restorative Technique using cotton rolls

Procedure

Atraumatic Restorative Technique using cotton rolls.

Other names: Atraumatic Restorative Technique

Atraumatic Restorative Technique

Procedure

Atraumatic Restorative Technique is typically used in Minimally invasive Dentistry.

This restoration technique is made using only hand instruments and is possible to be carried out in children in schools.

This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier.

Primary outcomes

  1. Number of teeth with fractured restorations.

    Time frame: 2 years

    The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Collaborators

  • Academic Centre for Dentistry in Amsterdam

Registry information

Official study title

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 16, 2013
Registry last updated
Aug 16, 2013

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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