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

White Spot Lesion Clinical Trial

Official title:

Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114475
• Other study ID #: UDDS-Ortho-01-2017
• Status: Completed
• Phase: N/A
• First received: April 11, 2017
• Last updated: October 22, 2017
• Start date: June 15, 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.

Before brackets' bonding (T0) the operator will evaluate with intraoral clinical examination and take intraoral photographs and evaluate with DIAGNOdent. Then after brackets' placement on teeth, the CO2 laser will be applied to the area of enamel about 2 mm of width around orthodontic brackets in a split mouth design. To blind the intervention sides on patients the control sides will receive nontherapeutic light.

Then intraoral photographs will be taken and the teeth will be assessed with DIAGNOdent (T1).

All patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of fluoride twice a day. After 4 weeks of irradiation (T2) the patients will be examined for white spot lesions formation by clinical examination using Geiger index, photographic examination using AutoCAD 2009 evaluating formation and area percentage of white spot lesions, and the degree of demineralization will be assessed with DIAGNOdent. The all exams will also be done after 12 weeks of irradiation (T3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• Adult patients with permanent occlusion at age 15-25 years.

• No previous orthodontic treatment

• Good oral hygiene

• Need to orthodontic treatment with fixed appliances

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

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

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

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus
Syrian Arab Republic	Higher Institution for Laser Research and Applications	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (10)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

Seino PY, Freitas PM, Marques MM, de Souza Almeida FC, Botta SB, Moreira MS. Influence of CO2 (10.6 µm) 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)