Evaluation of the Contamination of Ligatures

NCT ID: NCT04185987

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-03-20

Brief Summary

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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

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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.

Conditions

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Orthodontics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

2 a cross-over, in vivo study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Leone slide low friction elastomeric ligature

Intervention Type OTHER

Leone slide low friction elastomeric ligature application

RMO tough - o energy elastomeric ligature

Intervention Type OTHER

RMO tough - o energy elastomeric ligature application

Dentsply sili tie elastomeric ligature

Intervention Type OTHER

Dentsply sili tie elastomeric ligature application

AO twisted ended ligature wire

Intervention Type OTHER

AO twisted ended ligature wire application

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)

Group Type EXPERIMENTAL

Leone slide low friction elastomeric ligature

Intervention Type OTHER

Leone slide low friction elastomeric ligature application

RMO tough - o energy elastomeric ligature

Intervention Type OTHER

RMO tough - o energy elastomeric ligature application

Dentsply sili tie elastomeric ligature

Intervention Type OTHER

Dentsply sili tie elastomeric ligature application

AO twisted ended ligature wire

Intervention Type OTHER

AO twisted ended ligature wire application

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)

Group Type EXPERIMENTAL

Leone slide low friction elastomeric ligature

Intervention Type OTHER

Leone slide low friction elastomeric ligature application

RMO tough - o energy elastomeric ligature

Intervention Type OTHER

RMO tough - o energy elastomeric ligature application

Dentsply sili tie elastomeric ligature

Intervention Type OTHER

Dentsply sili tie elastomeric ligature application

AO twisted ended ligature wire

Intervention Type OTHER

AO twisted ended ligature wire application

surface roughness

surface roughness was measured before usage and after 4-weeks usage

Group Type EXPERIMENTAL

Leone slide low friction elastomeric ligature

Intervention Type OTHER

Leone slide low friction elastomeric ligature application

RMO tough - o energy elastomeric ligature

Intervention Type OTHER

RMO tough - o energy elastomeric ligature application

Dentsply sili tie elastomeric ligature

Intervention Type OTHER

Dentsply sili tie elastomeric ligature application

AO twisted ended ligature wire

Intervention Type OTHER

AO twisted ended ligature wire application

Interventions

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Leone slide low friction elastomeric ligature

Leone slide low friction elastomeric ligature application

Intervention Type OTHER

RMO tough - o energy elastomeric ligature

RMO tough - o energy elastomeric ligature application

Intervention Type OTHER

Dentsply sili tie elastomeric ligature

Dentsply sili tie elastomeric ligature application

Intervention Type OTHER

AO twisted ended ligature wire

AO twisted ended ligature wire application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Aysegul Gulec

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Çağlar Dağdeviren

Role: STUDY_CHAIR

University of Gaziantep

Fahriye Ekşi

Role: STUDY_CHAIR

University of Gaziantep

Mustafa sağlam

Role: STUDY_CHAIR

University of Gaziantep

Mehmet Kahraman

Role: STUDY_CHAIR

University of Gaziantep

Locations

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Gaziantep University

Gaziantep, Şehitkamil, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017/169

Identifier Type: -

Identifier Source: org_study_id

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