Caries; InitialNCT04903275
Caries Inhibition With CO2-Laser During Orthodontic Treatment
A study testing Topical fluoride application and Laser irradiation and Topical fluoride application in people with Caries; Initial, run by Plovdiv Medical University at 2 sites in Bulgaria.
Trial summary
The aim of the study is to assess the viability and efficacy of carbon dioxide laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Initial
- What is being tested?
- Topical fluoride application and Laser irradiation and Topical fluoride application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesBulgaria
- Study dates
- 1 Sep 2021to 1 Aug 2023
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants in the study are children ages 12 and older, in good general health
- Children, requiring fixed orthodontic treatment (brackets)
- Children at high caries risk according to 'Oral disease risk assessment tool' accepted and used in the Department of Paediatric Dentistry, Faculty of Dental medicine, Medical University - Plovdiv, Bulgaria
- Children with untreated non-carious vestibular surfaces of the six maxillary anterior teeth of the permanent dentition (central and lateral incisors, canines) with ICDAS code 0
- Verbal assent from the child willing to comply with all study procedures and protocol
- Obtained written informed consent by the patient's parent/guardian for participation in the study
Who cannot join
- Children with systemic diseases that may affect oral health or oral microflora (such as diabetes, etc.)
- Children with medication intake that could affect the salivary flow or oral microflora (such as antibiotics, etc.)
- Children with mental or cognitive problems
- Patients with maxillary anterior permanent teeth affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)
Trial locations and contacts
2 sites in 1 country.
Bulgaria2 sites
Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
Plovdiv, 4000
Maria P Shindova, PhD, 0898390935, mariya.shindova@gmail.com
Ani B Belcheva, PhD, 00359889528932, abeltcheva@yahoo.com
Medical University - Plovdiv, Bulgaria
Plovdiv, 4000
Maria P Shindova, PhD, 0898390935, mariya.shindova@gmail.com
Ani B Belcheva, PhD, 00359889528932, abeltcheva@yahoo.com
About this study
The aim of the study is to assess the viability and efficacy of carbon dioxide laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.
Read the detailed description
White spot lesions associated with orthodontic treatment are a common problem. The carbon dioxide laser is reported to be the most effective one in the prevention of dental caries. The study is designed as a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12-18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of the maxillary anterior teeth of the eligible patients will be exposed to carbon dioxide laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with the International Caries Detection and Assessment System (ICDAS) criteria and SoproLife ® Daylight and Blue fluorescence.
- Conditions
- Caries; Initial
- Being tested
- Topical fluoride application and Laser irradiation, Topical fluoride application
- Keywords
- carbon dioxide laser, fluoride, orthodontic treatment, caries inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical fluoride application and Laser irradiationProcedure or surgery
Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 μs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 μm; irradiation time-30 s.
Topical fluoride applicationProcedure or surgery
Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth
| Study group | Role | What they receive |
|---|---|---|
| Fluoride and Laser | Experimental | In the split-mouth design, the left maxillary anterior teeth receive topical fluoride application and carbon dioxide (CO2) laser irradiation. Receives: Procedure: Topical fluoride application and Laser irradiation |
| Fluoride | Active comparator | In the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application. Receives: Procedure: Topical fluoride application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes into International Caries Detection and Assessment System (ICDAS) codes
The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin.
Measured: 1 year
Secondary outcomes (1)
Changes in SoproLife ® scores
The SOPROlife score is a visual assessment of the caries levels. The SoproLife ® daylight intraoral camera (SoproLife ® Daylight mode) is used to record an intraoral picture with Sopro-imaging software (Acteon, Sopro, La Ciotat, France). The SoproLife ® blue fluorescence mode scores range from 0 to 5. Code of '0' is given when the surface appears shiny green, the enamel appears sound, and there are no visible changes, code '1' - a tiny, thin red shimmer is observed, no red dots appeared, code '2' - darker red spots are visible, code '3' - dark red spots have extended, a slight beginning roughness of the red areas can be visible, and codes '4-6' represent larger carious lesions in dentin.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries; InitialStudies 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
- randomized, split-mouth controlled, clinical trial
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ani B Belcheva, PhD, Study director, Medical University Plovdiv, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903275
- Sponsor's protocol ID
- MedicalUniversity_LaserCentre
- Status last verified
- Jun 2021
- First submitted
- 21 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belcheva AB, Shindova MP. Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial. Trials. 2022 Mar 12;23(1):208. doi: 10.1186/s13063-022-06117-y.
PubMed 35279220
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Inhibition With CO2-Laser During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04903275
- Acronym / sponsor ID
- MedicalUniversity_LaserCentre
- Conditions
- Caries; Initial
- Keywords
- carbon dioxide laser, fluoride, orthodontic treatment, caries inhibition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 26 May 2021 (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.
The aim of the study is to assess the viability and efficacy of carbon dioxide laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.
Detailed description
White spot lesions associated with orthodontic treatment are a common problem. The carbon dioxide laser is reported to be the most effective one in the prevention of dental caries. The study is designed as a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12-18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of the maxillary anterior teeth of the eligible patients will be exposed to carbon dioxide laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with the International Caries Detection and Assessment System (ICDAS) criteria and SoproLife ® Daylight and Blue fluorescence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, split-mouth controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Fluoride and Laser | Experimental | Procedure: Topical fluoride application and Laser irradiationIn the split-mouth design, the left maxillary anterior teeth receive topical fluoride application and carbon dioxide (CO2) laser irradiation. |
| Fluoride | Active comparator | Procedure: Topical fluoride applicationIn the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Participants in the study are children ages 12 and older, in good general health
- Children, requiring fixed orthodontic treatment (brackets)
- Children at high caries risk according to 'Oral disease risk assessment tool' accepted and used in the Department of Paediatric Dentistry, Faculty of Dental medicine, Medical University - Plovdiv, Bulgaria
- Children with untreated non-carious vestibular surfaces of the six maxillary anterior teeth of the permanent dentition (central and lateral incisors, canines) with ICDAS code 0
- Verbal assent from the child willing to comply with all study procedures and protocol
Key exclusion criteria (4 listed)
- Children with systemic diseases that may affect oral health or oral microflora (such as diabetes, etc.)
- Children with medication intake that could affect the salivary flow or oral microflora (such as antibiotics, etc.)
- Children with mental or cognitive problems
- Patients with maxillary anterior permanent teeth affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)
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 |
|---|---|---|
| Topical fluoride application and Laser irradiationTopical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 μs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 μm; irradiation time-30 s. | Procedure or surgery | Fluoride and Laser |
| Topical fluoride applicationTopical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth | Procedure or surgery | Fluoride |
Primary outcome
Changes into International Caries Detection and Assessment System (ICDAS) codes
Time frame: 1 year
The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin.
1 secondary outcome
Changes in SoproLife ® scores
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Derived from this study: PubMed 35279220Belcheva AB, Shindova MP. Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial. Trials. 2022 Mar 12;23(1):208. doi: 10.1186/s13063-022-06117-y.
- 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.
Ani B Belcheva, PhD study director
Medical University Plovdiv, Bulgaria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical fluoride application and Laser irradiation and Topical fluoride application in people with Caries; Initial, run by Plovdiv Medical University at 2 sites in Bulgaria.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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 Bulgaria. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Shindova, PhD (00359898390935, mariya.shindova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes into International Caries Detection and Assessment System (ICDAS) codes (time frame: 1 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 NCT04903275, which also lists 1 linked publication.
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 10 Jun 2021.