Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition

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

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.

Study Overview

• Status: Completed
• Conditions: Infection; Dentin Caries
• Intervention / Treatment: Procedure: Atraumatic restorative treatment

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Atraumatic restorative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of microbiological parameters	Change at the counts of microorganisms	6 months
Microscopic analyses of the marginal gap formation	Change at the marginal integrity of restorations	6 months

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Meltem Tekbas Atay, PhD, Department of Restorative Dentistry, Faculty of Dentistry, Trakya University, Edirne, Turkey; Study Chair: Fatma Koray, Prof. Dr., Department of Restorative Dentistry, Faculty of Dentistry, Yeniyüzyıl University, Istanbul, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2009
• Primary Completion (Actual): March 3, 2011
• Study Completion (Actual): March 3, 2011

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Glass ionomer cement; Atraumatic restorative treatment; Marginal adaptation
• Other Study ID Numbers: 1432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO