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

NCT03738839 | Completed DMC

• 1 other identifier: TSA-11-3585
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

White Spot Lesions; Direct Bonding; Indirect Bonding; Quantitative Light-Induced Fluorescence

Outcome Measures

Primary Outcomes (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.

  up to 2 year

Secondary Outcomes (1)

• Quantitative white spot lesion amounts

  up to 2 year

Study Arms (3)

Direct Bonding

EXPERIMENTAL

On the individual teeth Conventional bracket placement Use conventional composite

Device: Quantitative Light-Induced Fluorescence; Procedure: Direct bonding

Indirect bonding

EXPERIMENTAL

On the dental stone models Indirect bracket placement Use flowable composite Use transfer trays

Device: Quantitative Light-Induced Fluorescence; Procedure: Indirect bonding

Quantitative Light-Induced Fluorescence

ACTIVE COMPARATOR

Use special device and software Determination of the number and effect of caries

Device: Quantitative Light-Induced Fluorescence; Procedure: Direct bonding; Procedure: Indirect bonding

Interventions

Quantitative Light-Induced Fluorescence DEVICE

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

Direct Bonding; Indirect bonding; Quantitative Light-Induced Fluorescence

Direct bonding PROCEDURE

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

Direct Bonding; Quantitative Light-Induced Fluorescence

Indirect bonding PROCEDURE

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

Indirect bonding; Quantitative Light-Induced Fluorescence

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Related Publications (8)

• 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.

  PMID: 2816842 BACKGROUND

• 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.

  PMID: 10949838 BACKGROUND

• 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.

  PMID: 10194277 BACKGROUND

• 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.

  PMID: 6758594 RESULT

• 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.

  PMID: 27871699 RESULT

• 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.

  PMID: 26926020 RESULT

• 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.

  PMID: 21208070 RESULT

• 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.

  PMID: 31375814 DERIVED

MeSH Terms

Interventions

Quantitative Light-Induced Fluorescence; Sondhi Indirect Bonding Resin

Intervention Hierarchy (Ancestors)

Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Diagnosis, Oral; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Model Details: Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 13, 2018
• Study Start: July 28, 2011
• Primary Completion: November 27, 2013
• Study Completion: January 5, 2016
• Last Updated: November 13, 2018

Record last verified: 2018-11