Evaluation of the Contamination of Ligatures

Orthodontics Clinical Trial

Official title:

Evaluation of the Contamination of Elastomeric Ligatures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185987
• Other study ID #: 2017/169
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: July 2020
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontics

Intervention

Other:
• Leone slide low friction elastomeric ligature
Leone slide low friction elastomeric ligature application
• RMO tough - o energy elastomeric ligature
RMO tough - o energy elastomeric ligature application
• Dentsply sili tie elastomeric ligature
Dentsply sili tie elastomeric ligature application
• AO twisted ended ligature wire
AO twisted ended ligature wire application

Locations

Country	Name	City	State
Turkey	Gaziantep University	Gaziantep	Sehitkamil

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gingival index	Measurement of gingival index	through study completion, 18 weeks
Primary	Microbial colonisation change of S mutans	Measurement of microbial colonisation change of the interventions with real time PCR	up to 18 weeks
Primary	surface roughness identification with atomic force microscope	measurement of surface roughness identification of the interventions by atomic force microscope	up to 4 weeks
Secondary	Plaque index	Measurement of plaque index	through study completion, 18 weeks