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A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method

NCT03738839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-11-13

No results posted yet for this study

Summary

The aim of this 2-arm parallel trial was to evaluate enamel demineralization after an indirect bonding technique in comparison to a direct bonding technique group using the quantitative light-induced fluorescence method. Thirty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. Eligibility criteria included moderate crowding in the maxillary and mandibular dental arch, good oral hygiene, absence of craniofacial anomalies, no previous orthodontic treatment and no deciduous, congenitally missing or extracted teeth. Randomization was made at the start of the study with a statistical analysis program (SAS Institute Inc., Cary, NC, USA.). For the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive, while the patients in the direct bonding group received a bonding procedure with a conventional composite adhesive. Records were taken using quantitative light-induced fluorescence (QLF) with a Digital Biluminator (Inspektor Research Systems, Amsterdam, the Netherlands) in the pretreatment and posttreatment examination phases. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The fluorescence loss, lesion area and percentage of fluorescence loss were determined using the system's software. The primary outcome of this study was evaluation of the effects of bonding techniques on white spot lesion formation by using the QLF method. Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4. It was not possible for the clinicians and their interventions to be blocked. The patients and the specialists were blinded to the treatment groups when their treatment groups were aware.

Conditions

  • White Spot Lesion of Tooth
  • Orthodontic Malocclusion

Interventions

DEVICE

Quantitative Light-Induced Fluorescence

White spot lesion on the tooth surfaces detected with Quantitative Light-Induced Fluorescence Orthodontic Bonding.

PROCEDURE

Direct bonding

The patients in the direct bonding group received a bonding procedure with a conventional composite adhesive.

PROCEDURE

Indirect bonding

For the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive.

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-28
Primary Completion
2013-11-27
Completion
2016-01-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738839 on ClinicalTrials.gov