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Evaluation of the Contamination of Ligatures

Not Applicable
Completed
Conditions
Orthodontics
Interventions
Other: Leone slide low friction elastomeric ligature
Other: RMO tough - o energy elastomeric ligature
Other: Dentsply sili tie elastomeric ligature
Other: AO twisted ended ligature wire
Registration Number
NCT04185987
Lead Sponsor
University of Gaziantep
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
surface roughnessAO twisted ended ligature wiresurface roughness was measured before usage and after 4-weeks usage
Plaque indexAO twisted ended ligature wirePlaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Gingival indexDentsply sili tie elastomeric ligatureGingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Plaque indexLeone slide low friction elastomeric ligaturePlaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Plaque indexRMO tough - o energy elastomeric ligaturePlaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Gingival indexRMO tough - o energy elastomeric ligatureGingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Microbial colonisationAO twisted ended ligature wiremicrobial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Microbial colonisationLeone slide low friction elastomeric ligaturemicrobial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Gingival indexAO twisted ended ligature wireGingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
surface roughnessDentsply sili tie elastomeric ligaturesurface roughness was measured before usage and after 4-weeks usage
surface roughnessLeone slide low friction elastomeric ligaturesurface roughness was measured before usage and after 4-weeks usage
surface roughnessRMO tough - o energy elastomeric ligaturesurface roughness was measured before usage and after 4-weeks usage
Microbial colonisationRMO tough - o energy elastomeric ligaturemicrobial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Microbial colonisationDentsply sili tie elastomeric ligaturemicrobial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Gingival indexLeone slide low friction elastomeric ligatureGingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Plaque indexDentsply sili tie elastomeric ligaturePlaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)
Primary Outcome Measures
NameTimeMethod
Microbial colonisation change of S mutansup to 18 weeks

Measurement of microbial colonisation change of the interventions with real time PCR

surface roughness identification with atomic force microscopeup to 4 weeks

measurement of surface roughness identification of the interventions by atomic force microscope

Secondary Outcome Measures
NameTimeMethod
Plaque indexthrough study completion, 18 weeks

Measurement of plaque index

Trial Locations

Locations (1)

Gaziantep University

🇹🇷

Gaziantep, Şehitkamil, Turkey

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