Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets

NCT03114475 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white spot lesions formation around orthodontic brackets. 25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser will be applied in a split mouth design around orthodontic brackets in two contrast quarters of mouth in every patient and the other quarters will serve as a control. The white spot lesion formation will be monitored around the brackets during the orthodontic treatment after four and twelve weeks of irradiation with laser.

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (4)

• Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets.

  This will depend on the presence or absence of white spot formation assessed clinically.

  The status of white spot formation will be judged at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after irradiation (T3)

• Change in the Extent of White Spot Formation

  This will be assessed clinically using Geiger index (Step 1: no white spot lesions, Step 2: the white spot lesion is less than the third of the tooth surface area, Step 3: the white spot lesion is more than the third of the tooth surface area, Step 4: severe white spot lesions and caries)

  Extent of white spot formation will be measured 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after laser irradiation (T2) and at twelve weeks after laser irradiation (T3)

• Change in the Percentage of White Spot Lesion Area

  This will be assessed using digital images.The percentage of white spot lesion area to the area of the labial surface of the tooth on digital images will be calculated using AutoCAD 2013 program.

  Percentage of white spot lesion area will be assessed at 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after irradiation (T2) and at twelve weeks after irradiation (T3)

• Change in the degree of demineralization

  The degree of demineralization will be evaluated by DIAGNOdent Pen around the orthodontic brackets.

  The degree of demineralization will be evaluated at: t 10 minutes before taking the impressions (T0), five minutes following brackets' placement and irradiation (T1), at four weeks after irradiation (T2) and at twelve weeks after irradiation (T3)

Study Arms (2)

CO2 Laser Irradiation

EXPERIMENTAL

This group of patients will be treated by splitting the dental arches into four quadrants: upper right, upper left, lower right and lower left. Two quadrants will receive the CO2 laser irradiation whereas the remaining two quadrants will receive no treatment (i.e. the placebo light).

Radiation: CO2 laser irradiation

Placebo

PLACEBO COMPARATOR

A placebo light will be used as if the patient is irradiated with the laser beam.

Other: Placebo

Interventions

CO2 laser irradiation RADIATION

CO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket

CO2 Laser Irradiation

Placebo OTHER

No irradiation is going to be applied in the intervention. Just a red light will be used as placebo.

Placebo

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult patients with permanent occlusion at age 15-25 years.
• No previous orthodontic treatment
• Good oral hygiene
• Need to orthodontic treatment with fixed appliances

You may not qualify if:

• Patients with systemic diseases or syndromes
• Patients with existence of enamel fluorosis
• Patients with existence of amelogenesis imperfecta or hypocalcified enamel
• Patients with existence of restorations or crowns or carious lesions on the labial surfaces of teeth.
• Patients who received fluoride treatment within the last three months prior to being enrolled in the study.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (2)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Higher Institution for Laser Research and Applications

Damascus, Syria

Location

Related Publications (11)

• Esteves-Oliveira M, Zezell DM, Meister J, Franzen R, Stanzel S, Lampert F, Eduardo CP, Apel C. CO2 Laser (10.6 microm) parameters for caries prevention in dental enamel. Caries Res. 2009;43(4):261-8. doi: 10.1159/000217858. Epub 2009 May 8.

  PMID: 19439947 BACKGROUND

• Esteves-Oliveira M, Pasaporti C, Heussen N, Eduardo CP, Lampert F, Apel C. Prevention of toothbrushing abrasion of acid-softened enamel by CO(2) laser irradiation. J Dent. 2011 Sep;39(9):604-11. doi: 10.1016/j.jdent.2011.06.007. Epub 2011 Jun 30.

  PMID: 21741428 BACKGROUND

• Gomez J. Detection and diagnosis of the early caries lesion. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S3. doi: 10.1186/1472-6831-15-S1-S3. Epub 2015 Sep 15.

  PMID: 26392124 BACKGROUND

• Miresmaeili A, Farhadian N, Rezaei-soufi L, Saharkhizan M, Veisi M. Effect of carbon dioxide laser irradiation on enamel surface microhardness around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2014 Aug;146(2):161-5. doi: 10.1016/j.ajodo.2014.04.023.

  PMID: 25085298 BACKGROUND

• Rechmann P, Fried D, Le CQ, Nelson G, Rapozo-Hilo M, Rechmann BM, Featherstone JD. Caries inhibition in vital teeth using 9.6-mum CO2-laser irradiation. J Biomed Opt. 2011 Jul;16(7):071405. doi: 10.1117/1.3564908.

  PMID: 21806251 BACKGROUND

• Rechmann P, Charland DA, Rechmann BM, Le CQ, Featherstone JD. In-vivo occlusal caries prevention by pulsed CO2 -laser and fluoride varnish treatment--a clinical pilot study. Lasers Surg Med. 2013 Jul;45(5):302-10. doi: 10.1002/lsm.22141. Epub 2013 Jun 4.

  PMID: 23737079 BACKGROUND

• Seino PY, Freitas PM, Marques MM, de Souza Almeida FC, Botta SB, Moreira MS. Influence of CO2 (10.6 mum) and Nd:YAG laser irradiation on the prevention of enamel caries around orthodontic brackets. Lasers Med Sci. 2015 Feb;30(2):611-6. doi: 10.1007/s10103-013-1380-8. Epub 2013 Jun 30.

  PMID: 23812850 BACKGROUND

• Souza-Gabriel AE, Colucci V, Turssi CP, Serra MC, Corona SA. Microhardness and SEM after CO(2) laser irradiation or fluoride treatment in human and bovine enamel. Microsc Res Tech. 2010 Oct;73(11):1030-5. doi: 10.1002/jemt.20827.

  PMID: 20146349 BACKGROUND

• Stangler LP, Romano FL, Shirozaki MU, Galo R, Afonso AM, Borsatto MC, Matsumoto MA. Microhardness of enamel adjacent to orthodontic brackets after CO2 laser irradiation and fluoride application. Braz Dent J. 2013 Sep-Oct;24(5):508-12. doi: 10.1590/0103-6440201302292.

  PMID: 24474294 BACKGROUND

• Steiner-Oliveira C, Rodrigues LK, Soares LE, Martin AA, Zezell DM, Nobre-dos-Santos M. Chemical, morphological and thermal effects of 10.6-microm CO2 laser on the inhibition of enamel demineralization. Dent Mater J. 2006 Sep;25(3):455-62. doi: 10.4012/dmj.25.455.

  PMID: 17076314 BACKGROUND

• Raghis T, Mahmoud G, Abdullah A, Hamadah O. Enamel resistance to demineralisation around orthodontic brackets after CO2 laser irradiation: a randomised clinical trial. J Orthod. 2018 Dec;45(4):234-242. doi: 10.1080/14653125.2018.1504410. Epub 2018 Aug 2.

  PMID: 30071781 DERIVED

Study Officials

• Tuqa Raghis, DDS

  MSc student, Department of Orthodontics, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Ghiath Mahmoud, DDS MSc PhD

  Senior Lecturer in Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The non-irradiated side of the mouth will receive a placebo light (i.e. not the laser beam).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth design, the mouth will be split into four quadrants. Two quadrants will receive the active treatment, whereas the opposing two quadrants will receive the placebo.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: June 15, 2016
• Primary Completion: April 20, 2017
• Study Completion: September 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (2)