NCT04185987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

November 26, 2019

Last Update Submit

July 14, 2020

Conditions

Orthodontics

Keywords

bacterial adhesionelastomeric ligatures

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Plaque index

    through study completion, 18 weeks

Other Outcomes (1)

  • Gingival index

    through study completion, 18 weeks

Study Arms (4)

Microbial colonisation

EXPERIMENTAL

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 ligatureOther: RMO tough - o energy elastomeric ligatureOther: Dentsply sili tie elastomeric ligatureOther: AO twisted ended ligature wire

Plaque index

EXPERIMENTAL

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 ligatureOther: RMO tough - o energy elastomeric ligatureOther: Dentsply sili tie elastomeric ligatureOther: AO twisted ended ligature wire

Gingival index

EXPERIMENTAL

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 ligatureOther: RMO tough - o energy elastomeric ligatureOther: Dentsply sili tie elastomeric ligatureOther: AO twisted ended ligature wire

surface roughness

EXPERIMENTAL

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

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

Interventions

Leone slide low friction elastomeric ligatureOTHER

Leone slide low friction elastomeric ligature application

Gingival indexMicrobial colonisationPlaque indexsurface roughness
RMO tough - o energy elastomeric ligatureOTHER

RMO tough - o energy elastomeric ligature application

Gingival indexMicrobial colonisationPlaque indexsurface roughness
Dentsply sili tie elastomeric ligatureOTHER

Dentsply sili tie elastomeric ligature application

Gingival indexMicrobial colonisationPlaque indexsurface roughness
AO twisted ended ligature wireOTHER

AO twisted ended ligature wire application

Gingival indexMicrobial colonisationPlaque indexsurface roughness

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 2 a cross-over, in vivo study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 4, 2019

Study Start

August 10, 2017

Primary Completion

January 20, 2018

Study Completion

March 20, 2018

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

TU(1)