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Completed

NCT Number: NCT04813744

Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition

Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. In the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (GIC) which does not require special devices for mixing and hardening is used as a filling material. Because of these advantages of the treatment, the usage fields of ART have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. But only a few research has been conducted on ART in adults and it must be investigated in terms of the clinical safety of ART by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. The purpose of this study is to investigate the reliability of ART in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. In the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. The restorations of the teeth were carried out using ART technique with a GIC which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. After six months, the microbiological assessment was repeated such as baseline. Marginal adaptation and the presence of the gaps in the ART restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. At the end of the study, the teeth were restored by the conventional methods and using composite material.

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients:

  • 19-35 years of age;
  • Good general health;
  • High risk of caries;
  • No evident signs of occlusal parafunctions.

Tooth:

  • Molar tooth;
  • 3-4 mm depth occlusal dentin caries;
  • Vital;
  • In occlusion;
  • Proper tooth axes.

Exclusion criteria

Patient:

  • Using regular medication;
  • Pregnancy or lactation;
  • Received radiotherapy or chemotherapy;
  • Tooth clenching, bruxism.

Tooth:

  • Spontaneous pain;
  • Radiographic alterations in the periapical region;
  • Presence of tooth mobility;
  • Previously restored;
  • Broken and/ or cracked.

Treatment and study plan

Atraumatic Restorative Treatment

Procedure

Primary outcomes

  1. Evaluation of microbiological parameters

    Time frame: 6 months

    Change at the counts of microorganisms

  2. Microscopic analyses of the marginal gap formation

    Time frame: 6 months

    Change at the marginal integrity of restorations

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Investigation of Atraumatic Restorative Treatment by in Vivo and in Vitro Methods in Terms of the Microbiological, Marginal Adaptation and Microleakage

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

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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