White Spot LesionNCT03114475
Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets
A study testing CO2 laser irradiation in people with White Spot Lesion, run by Damascus University at 2 sites in Syria.
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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- CO2 laser irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesSyria
- Study dates
- 15 Jun 2016to Sep 2017
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients with permanent occlusion at age 15-25 years.
- No previous orthodontic treatment
- Good oral hygiene
- Need to orthodontic treatment with fixed appliances
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Syria2 sites
Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18
Higher Institution for Laser Research and Applications
Damascus
About this study
Official title: Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial
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.
Read the detailed 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).
- Conditions
- White Spot Lesion
- Being tested
- CO2 laser irradiation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laser irradiationRadiation
CO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket
PlaceboOther
No irradiation is going to be applied in the intervention. Just a red light will be used as placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: CO2 laser irradiation |
| Placebo | Placebo comparator | A placebo light will be used as if the patient is irradiated with the laser beam. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Jun 2016
- Primary completion20 Apr 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuqa Raghis, DDS, Principal investigator, MSc student, Department of Orthodontics, University of Damascus Dental SchoolGhiath Mahmoud, DDS MSc PhD, Study director, Senior Lecturer in Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114475
- Sponsor's protocol ID
- UDDS-Ortho-01-2017
- Status last verified
- Oct 2017
- First submitted
- 11 Apr 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19439947Esteves-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.
PubMed 21741428Gomez 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.
PubMed 26392124Miresmaeili 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.
PubMed 25085298Rechmann 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.
PubMed 21806251Rechmann 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.
PubMed 23737079Seino 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.
PubMed 23812850Souza-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.
PubMed 20146349Stangler 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.
PubMed 24474294Steiner-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.
PubMed 17076314Raghis 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.
PubMed 30071781
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enamel Resistance to White Spot Lesion Formation Around Orthodontic Brackets After CO2 Laser Irradiation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03114475
- Acronym / sponsor ID
- UDDS-Ortho-01-2017
- Conditions
- White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CO2 Laser Irradiation | Experimental | Radiation: CO2 laser irradiationThis 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). |
| Placebo | Placebo comparator | Other: PlaceboA placebo light will be used as if the patient is irradiated with the laser beam. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult patients with permanent occlusion at age 15-25 years.
- No previous orthodontic treatment
- Good oral hygiene
- Need to orthodontic treatment with fixed appliances
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laser irradiationCO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket | Radiation | CO2 Laser Irradiation |
| PlaceboNo irradiation is going to be applied in the intervention. Just a red light will be used as placebo. | Other | Placebo |
Primary outcome
Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets.
Time frame: 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)
This will depend on the presence or absence of white spot formation assessed clinically.
Change in the Extent of White Spot Formation
Time frame: 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)
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)
Change in the Percentage of White Spot Lesion Area
Time frame: 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)
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.
Change in the degree of demineralization
Time frame: 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)
The degree of demineralization will be evaluated by DIAGNOdent Pen around the orthodontic brackets.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background: PubMed 19439947Esteves-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.
- Background: PubMed 21741428Esteves-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.
- Background: PubMed 26392124Gomez 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.
- Background: PubMed 25085298Miresmaeili 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.
- Background: PubMed 21806251Rechmann 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.
- Background: PubMed 23737079Rechmann 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.
- Background: PubMed 23812850Seino 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.
- Background: PubMed 20146349Souza-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.
- Background: PubMed 24474294Stangler 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.
- Background: PubMed 17076314Steiner-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.
- Derived from this study: PubMed 30071781Raghis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuqa Raghis, DDS principal investigator
MSc student, Department of Orthodontics, University of Damascus Dental School
Ghiath Mahmoud, DDS MSc PhD study director
Senior Lecturer in Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser irradiation in people with White Spot Lesion, run by Damascus University at 2 sites in Syria.
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 4 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in White Formation Status we will evaluate the degree of demineralization by DIAGNOdent Pen around the orthodontic brackets. (time frame: 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)). The study lists 4 primary outcomes in all. 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 NCT03114475, which also lists 11 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 24 Oct 2017.