Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition

NCT ID: NCT04813744

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-09
• Study Completion Date: 2011-03-03

Brief Summary

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.

Conditions

Dentin Caries; Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigation of atraumatic restorative treatment in adults with a high risk of caries

The study group included a total of 25 healthy individuals with high caries risk who had molar teeth in their mouth with 3-4 mm depth occlusal dentin caries. In the clinical study, the infected and demineralized dentin was cleaned manually with a sterile excavator. The dentin sample was taken from the last removable and affected dentin layer at the cavity floor by one excavation for microbiological assessment. The teeth were restored with a conventional glass ionomer cement. In the 6th month, restorations were removed by using low-speed round steel bur, and the dentin samples were removed with an excavator from the cavity floor to repeat the microbiological assessment. In the first week and 6th month of atraumatic restorative treatment, the impressions were taken from the restored teeth to prepare replicas. The replicas of the twenty teeth out of 25 were randomly selected to evaluate of marginal adaptation under scanning electron microscopy.

Group Type: EXPERIMENTAL

Atraumatic restorative treatment

Intervention Type: PROCEDURE

Interventions

Atraumatic restorative treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Meltem Tekbas Atay

Project manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meltem Tekbas Atay, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Restorative Dentistry, Faculty of Dentistry, Trakya University, Edirne, Turkey

Fatma Koray, Prof. Dr.

Role: STUDY_CHAIR

Department of Restorative Dentistry, Faculty of Dentistry, Yeniyüzyıl University, Istanbul, Turkey

Other Identifiers

1432

Identifier Type: -

Identifier Source: org_study_id