ClinicalTrials.Veeva

Menu

Evaluation of the Contamination of Ligatures

U

University of Gaziantep

Status

Completed

Conditions

Orthodontics

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04185987
2017/169

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

12 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 4 patient groups

Microbial colonisation
Experimental group
Description:
microbial 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)
Treatment:
Other: AO twisted ended ligature wire
Other: Dentsply sili tie elastomeric ligature
Other: RMO tough - o energy elastomeric ligature
Other: Leone slide low friction elastomeric ligature
Plaque index
Experimental group
Description:
Plaque 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)
Treatment:
Other: AO twisted ended ligature wire
Other: Dentsply sili tie elastomeric ligature
Other: RMO tough - o energy elastomeric ligature
Other: Leone slide low friction elastomeric ligature
Gingival index
Experimental group
Description:
Gingival 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)
Treatment:
Other: AO twisted ended ligature wire
Other: Dentsply sili tie elastomeric ligature
Other: RMO tough - o energy elastomeric ligature
Other: Leone slide low friction elastomeric ligature
surface roughness
Experimental group
Description:
surface roughness was measured before usage and after 4-weeks usage
Treatment:
Other: AO twisted ended ligature wire
Other: Dentsply sili tie elastomeric ligature
Other: RMO tough - o energy elastomeric ligature
Other: Leone slide low friction elastomeric ligature

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems