CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Quantitative Light-Induced Fluorescence +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03738839
NCT03738839N/ACompleted

A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence (QLF) Method Between Direct Bonding and Indirect Bonding Techniques in Adolescents

TC Erciyes University·interventional·Posted Nov 13, 2018·Updated Nov 13, 2018

In Brief

A clinical study evaluating Quantitative Light-Induced Fluorescence, Direct bonding, and 1 other intervention for White Spot Lesion of Tooth and Orthodontic Malocclusion. Completed, enrolled 51 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2018
Enrollment StartJul 28, 2011
Primary CompletionNov 27, 2013
Study CompletionJan 5, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.6 years ago

Interventions

Quantitative Light-Induced Fluorescencedevice

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

Direct bondingprocedure

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

Indirect bondingprocedure

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