Clinical trial NCT04813744: Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition
Official title: Investigation of Atraumatic Restorative Treatment by in Vivo and in Vitro Methods in Terms of the Microbiological, Marginal Adaptation and Microleakage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Caries
Infection
Keywords: Atraumatic restorative treatment
Glass ionomer cement
Marginal adaptation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The clinical studies were carried out in the occlusal dentin caries of 25 permanent molar teeth in participants with high caries risk and between 19-35 years of age. The caries tissue were removed with hand instruments in accordance procedure of atraumatic restorative treatment. Then the total counts of bacteria, facultative anaerobe bacteria, Mutans Streptococci, and Lactobacilli supp. counts in the affected dentin were evaluated quantitatively. The weights of samples were measured with an electronic balance (Shimadzu, Type AX200, Japan). The cavities were restored with a glass ionomer cement (KetacTM Molar Easymix, ESPE Dental AG, Seefeld, Germany). Twenty replicas of randomly selected ART restorations were prepared and marginal adaptation was evaluated by scanning electron microscopy. After 6 months, the same protocols were repeated. Data were analyzed with Paired Sample and Wilcoxon Paired t-tests, Pearson, Spearman correlation, and Chi-Square tests (p\< 0.05).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of microbiological parameters
timeFrame: 6 months
measure: Microscopic analyses of the marginal gap formation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Restorative Dentistry, Faculty of Dentistry, Trakya University, Edirne, Turkey
name: Meltem Tekbas Atay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Restorative Dentistry, Faculty of Dentistry, Yeniyüzyıl University, Istanbul, Turkey
name: Fatma Koray, Prof. Dr.
role: STUDY_CHAIR
References: