Flash-free Brackets and Dental Plaque

Orthodontic Treatment Clinical Trial

Official title:

Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187483
• Other study ID #: 13-11.1/9
• Status: Completed
• Phase: N/A
• First received: June 10, 2017
• Last updated: June 12, 2017
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: June 2017
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

Description:

Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).

Materials & Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• being systemically healthy

• having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.

Exclusion Criteria:

Related Conditions & MeSH terms

• Orthodontic Treatment

Intervention

Procedure:
• orthodontic treatment
orthodontic treatment in maxillary crowding

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of white spot lesion (WSL)	WSL is the first sign of caries	1 month
Secondary	plaque accumulation around the brackets	plaque deposits cause gingival inflammation	1 month
Secondary	microbial composition around the brackets	presence of pathogen bacteria is important	1 month