Clinical trial NCT04185987: Evaluation of the Contamination of Ligatures
Official title: Evaluation of the Contamination of Elastomeric Ligatures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Keywords: bacterial adhesion
elastomeric ligatures
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 a cross-over, in vivo study.
Primary purpose: BASIC_SCIENCE

Brief summary: This crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.

Detailed description: The development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. Orthodontic fixed appliances also impede the maintenance of oral hygiene. Plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque.

In patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. Enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in pH level because of the glucose metabolized by these cariogenic bacteria . The most commonly investigated bacteria among those mentioned above is Streptococcus Mutans. In the literature, it has been the subject of many studies, including those investigating the correlation between the S. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of S. mutans to nickel titanium and copper-nickel brackets, the difference in S. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on S. mutans colonization.

Non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. Manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. It was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch NITI to 19.25 SS.

To our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. In light of this information, present study was aimed to compare S. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. The surface structures of these ligature types also will be investigated by atomic force microscope (AFM) and the results of this investigation will be associated with the results of bacterial colonization amount.

Eligibility criteria: Inclusion Criteria:

* permanent teeth in the mouth
* patients with good oral hygiene
* patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period.

Exclusion Criteria:

* smoker

Primary outcomes:
measure: Microbial colonisation change of S mutans
timeFrame: up to 18 weeks
measure: surface roughness identification with atomic force microscope
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Plaque index
timeFrame: through study completion, 18 weeks
Other outcomes:
measure: Gingival index
timeFrame: through study completion, 18 weeks
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
state: Şehitkamil
Study officials:
affiliation: University of Gaziantep
name: Çağlar Dağdeviren
role: STUDY_CHAIR
affiliation: University of Gaziantep
name: Fahriye Ekşi
role: STUDY_CHAIR
affiliation: University of Gaziantep
name: Mustafa sağlam
role: STUDY_CHAIR
affiliation: University of Gaziantep
name: Mehmet Kahraman
role: STUDY_CHAIR
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