Evaluation of the Contamination of Ligatures

Evaluation of the Contamination of Elastomeric Ligatures

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.

Study Overview

• Status: Completed
• Conditions: Orthodontics
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şehitkamil
    • Gaziantep, Şehitkamil, Turkey, 27310
      • Gaziantep University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Microbial colonisation; 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)	Other: Leone slide low friction elastomeric ligature; Leone slide low friction elastomeric ligature application; Other: RMO tough - o energy elastomeric ligature; RMO tough - o energy elastomeric ligature application; Other: Dentsply sili tie elastomeric ligature; Dentsply sili tie elastomeric ligature application; Other: AO twisted ended ligature wire; AO twisted ended ligature wire application
EXPERIMENTAL: Plaque index; 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)	Other: Leone slide low friction elastomeric ligature; Leone slide low friction elastomeric ligature application; Other: RMO tough - o energy elastomeric ligature; RMO tough - o energy elastomeric ligature application; Other: Dentsply sili tie elastomeric ligature; Dentsply sili tie elastomeric ligature application; Other: AO twisted ended ligature wire; AO twisted ended ligature wire application
EXPERIMENTAL: Gingival index; 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)	Other: Leone slide low friction elastomeric ligature; Leone slide low friction elastomeric ligature application; Other: RMO tough - o energy elastomeric ligature; RMO tough - o energy elastomeric ligature application; Other: Dentsply sili tie elastomeric ligature; Dentsply sili tie elastomeric ligature application; Other: AO twisted ended ligature wire; AO twisted ended ligature wire application
EXPERIMENTAL: surface roughness; surface roughness was measured before usage and after 4-weeks usage	Other: Leone slide low friction elastomeric ligature; Leone slide low friction elastomeric ligature application; Other: RMO tough - o energy elastomeric ligature; RMO tough - o energy elastomeric ligature application; Other: Dentsply sili tie elastomeric ligature; Dentsply sili tie elastomeric ligature application; Other: AO twisted ended ligature wire; AO twisted ended ligature wire application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial colonisation change of S mutans	Measurement of microbial colonisation change of the interventions with real time PCR	up to 18 weeks
surface roughness identification with atomic force microscope	measurement of surface roughness identification of the interventions by atomic force microscope	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Measurement of plaque index	through study completion, 18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	Measurement of gingival index	through study completion, 18 weeks

Collaborators and Investigators

• Sponsor: University of Gaziantep
• Investigators: Study Chair: Çağlar Dağdeviren, University of Gaziantep; Study Chair: Fahriye Ekşi, University of Gaziantep; Study Chair: Mustafa sağlam, University of Gaziantep; Study Chair: Mehmet Kahraman, University of Gaziantep

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2017
• Primary Completion (ACTUAL): January 20, 2018
• Study Completion (ACTUAL): March 20, 2018

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: bacterial adhesion; elastomeric ligatures
• Other Study ID Numbers: 2017/169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No