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White Spot Lesion of ToothQLFNCT03738839

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

A study testing Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding in people with White Spot Lesion of Tooth and Orthodontic Malocclusion, run by TC Erciyes University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 21 yearsHealthy volunteers can take part
What is being tested?
Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
No sites listed yet
Study dates
28 Jul 2011to 5 Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • medical healthy subjects
  • mild to 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.

Who cannot join

  • severe crowding,
  • bad oral hygiene,
  • presence of craniofacial anomalies,
  • previous orthodontic, orthognathic or prosthetic treatment
  • presence of congenital teeth deficiency, deciduous or extracted teeth

About this study

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

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.

Read the detailed description

This study was single center, one-blinded, 2-arm parallel, randomized clinical trial with a 1:1 allocation ratio. No changes were made to the protocol after trial commencement. Initially, 60 patients who had been referred to a tertiary clinic in Kayseri, Turkey for orthodontic treatment between October 2011 and June 2013 were assessed for eligibility by the clinicians (A.Y.). The inclusion criteria for the experiment groups in this study were mild to 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. 60 patients were examined in the trial. Thirty-six patients were divided into groups with equal numbers of patients in each group. The study was completed with 31 patients. An analysis was performed on the 15 patients in the indirect bonding group and the 16 patients in the direct bonding group. Approval for the study was obtained from the Local Ethics Committee of the Faculty of Medicine at Erciyes University in Kayseri, Turkey (11-3585). Informed consent was obtained from all the patients included in the study. The consent was obtained from those over 18 years of age directly, and from the parents of those under 18 years of age. Standard treatment records, which are photographs, dental models and radiographs, were taken in the beginning of treatment and at the end of treatment from all patients included in the study. The patients were randomly allocated to 1 of 2 treatment groups: indirect bonding and direct bonding. In the direct bonding group, after the plaque structure on the teeth was cleaned with pumice and white elastic bur were etched with 37% phosphoric acid gel (3M-Dental Products, St Paul, Minnesota, USA) for 30 seconds, the teeth were rinsed and dried with oil-free compressed air for 15 seconds. After drying the enamel surface, the liquid primer Transbond XT (3M-Unitek, Monrovia, California, USA) was applied with a small brush and spread with oil-free compressed air. Pre-adjusted metal brackets which had values for the Roth prescription were then bonded using the conventional adhesive with a standard protocol and polymerized for 3 seconds per bracket with a multiwave light-emitting diode curing light.

In the indirect bonding group, alginate was utilized to take impressions of the maxillary and mandibular arches, and hard dental stone was used to cast the dental models. Following the trimming and drying of the dental models dried, guidelines were drawn for vertical and horizontal bracket-positioning using a black pencil. The separating agent Al Cote (Dentsply Trubyte, York, Pennsylvania, USA) was administered onto the surfaces of the teeth surfaces using a brush, and the casts were left to dry. The same brackets used in the direct bonding technique were used. The composite adhesive was administered onto the base of the bracket, and the bracket was then placed onto the marked area on the tooth surface. The excess resin was carefully removed with a hand instrument. After positioning the bracket, the composite adhesive was polymerized with a multiwave light-emitting diode curing light. After positioning of the bracket on the transfer models, the composite adhesive was polymerized for 3 seconds, and a 2-layer transfer tray was prepared using translucent soft silicone and thermoformed rigid Essix Plus plastic. The base of the brackets in the transfer tray was sandblasted to remove the separating agent. A flowable composite adhesive was applied to the bracket bases, and the transfer tray was then seated on the arch segment. The composite adhesive was polymerized for 3 seconds before and after removing the transfer tray. Excessive composite adhesive remnants were then removed using a tungsten carbide bur in an air rotor instrument. For all of the patients included in the study, orthodontic treatment and recommendations for how to use toothpaste containing fluoride, how to brush their teeth and diet habits were also added to reduce the number of white spot lesions and provide better treatment. The QLF images of all patients who underwent direct and indirect bonding were taken by the same observer in the beginning of fixed orthodontic treatment (T0) and immediately after removal of the appliances (T1) at the end of the treatment period using a QLF-D Biluminator 2-camera system (Inspektor Research Systems, Amsterdam, The Netherlands).

Being tested
Quantitative Light-Induced Fluorescence, Direct bonding, Indirect bonding
Keywords
White Spot Lesions, Direct Bonding, Indirect Bonding, Quantitative Light-Induced Fluorescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantitative Light-Induced FluorescenceDevice

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

  • Direct bondingProcedure or surgery

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

  • Indirect bondingProcedure or surgery

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

Study groups in NCT03738839
Study groupRoleWhat they receive
Direct BondingExperimentalOn the individual teeth Conventional bracket placement Use conventional composite
Receives: Device: Quantitative Light-Induced Fluorescence; Procedure: Direct bonding
Indirect bondingExperimentalOn the dental stone models Indirect bracket placement Use flowable composite Use transfer trays
Receives: Device: Quantitative Light-Induced Fluorescence; Procedure: Indirect bonding
Quantitative Light-Induced FluorescenceActive comparatorUse special device and software Determination of the number and effect of caries
Receives: Device: Quantitative Light-Induced Fluorescence; Procedure: Direct bonding; Procedure: Indirect bonding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. White spot lesion incidence

    In the indirect bonding technique group, less amount of white spot lesions are expected than the direct bonding technique in end of the treatment.

    Measured: up to 2 year

Secondary outcomes (1)
  1. Quantitative white spot lesion amounts

    The QLF method gives a quantitative result, it may be used efficiently for imaging of white spot lesion formation during or after orthodontic treatment.

    Measured: up to 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start28 Jul 2011
  3. Primary completion27 Nov 2013
  4. Study completion5 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738839
Sponsor's protocol ID
TSA-11-3585
Acronym
QLF
Status last verified
Nov 2018
First submitted
24 Oct 2018
Last updated
13 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ogaard B. Prevalence of white spot lesions in 19-year-olds: a study on untreated and orthodontically treated persons 5 years after treatment. Am J Orthod Dentofacial Orthop. 1989 Nov;96(5):423-7. doi: 10.1016/0889-5406(89)90327-2.

    PubMed 2816842
  • van der Veen MH, de Josselin de Jong E. Application of quantitative light-induced fluorescence for assessing early caries lesions. Monogr Oral Sci. 2000;17:144-62. doi: 10.1159/000061639.

    PubMed 10949838
  • Sondhi A. Efficient and effective indirect bonding. Am J Orthod Dentofacial Orthop. 1999 Apr;115(4):352-9. doi: 10.1016/s0889-5406(99)70252-0.

    PubMed 10194277
  • Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

    PubMed 6758594
  • Baysal A, Ulusoy SN, Uysal T. Evaluation of enamel demineralization in adolescents after rapid maxillary expansion using the quantitative light-induced fluorescence method: A single-center, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2016 Nov;150(5):731-739. doi: 10.1016/j.ajodo.2016.06.014.

    PubMed 27871699
  • Yagci A, Korkmaz YN, Buyuk SK, Yagci F, Atilla AO. White spot lesion formation after treatment with full-coverage rapid maxillary expanders. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):331-8. doi: 10.1016/j.ajodo.2015.08.015.

    PubMed 26926020
  • Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

    PubMed 21208070
  • Atilla AO, Ozturk T, Eruz MM, Yagci A. A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial. Eur J Orthod. 2020 Sep 11;42(4):441-453. doi: 10.1093/ejo/cjz058.

    PubMed 31375814

Questions about this trial

What is this clinical trial studying?

A study testing Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding in people with White Spot Lesion of Tooth and Orthodontic Malocclusion, run by TC Erciyes University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

White spot lesion incidence (time frame: up to 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738839, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.

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