White Spot Lesion of ToothQLFNCT03738839
A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method
A study testing Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding in people with White Spot Lesion of Tooth and Orthodontic Malocclusion, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth, Orthodontic Malocclusion
- What is being tested?
- Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2011to 5 Jan 2016
- 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- severe crowding,
- bad oral hygiene,
- presence of craniofacial anomalies,
- previous orthodontic, orthognathic or prosthetic treatment
- presence of congenital teeth deficiency, deciduous or extracted teeth
About this study
Official title: A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence (QLF) Method Between Direct Bonding and Indirect Bonding Techniques in Adolescents
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.
Read the detailed description
This study was single center, one-blinded, 2-arm parallel, randomized clinical trial with a 1:1 allocation ratio. No changes were made to the protocol after trial commencement. Initially, 60 patients who had been referred to a tertiary clinic in Kayseri, Turkey for orthodontic treatment between October 2011 and June 2013 were assessed for eligibility by the clinicians (A.Y.). The inclusion criteria for the experiment groups in this study were 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. 60 patients were examined in the trial. Thirty-six patients were divided into groups with equal numbers of patients in each group. The study was completed with 31 patients. An analysis was performed on the 15 patients in the indirect bonding group and the 16 patients in the direct bonding group. Approval for the study was obtained from the Local Ethics Committee of the Faculty of Medicine at Erciyes University in Kayseri, Turkey (11-3585). Informed consent was obtained from all the patients included in the study. The consent was obtained from those over 18 years of age directly, and from the parents of those under 18 years of age. Standard treatment records, which are photographs, dental models and radiographs, were taken in the beginning of treatment and at the end of treatment from all patients included in the study. The patients were randomly allocated to 1 of 2 treatment groups: indirect bonding and direct bonding. In the direct bonding group, after the plaque structure on the teeth was cleaned with pumice and white elastic bur were etched with 37% phosphoric acid gel (3M-Dental Products, St Paul, Minnesota, USA) for 30 seconds, the teeth were rinsed and dried with oil-free compressed air for 15 seconds. After drying the enamel surface, the liquid primer Transbond XT (3M-Unitek, Monrovia, California, USA) was applied with a small brush and spread with oil-free compressed air. Pre-adjusted metal brackets which had values for the Roth prescription were then bonded using the conventional adhesive with a standard protocol and polymerized for 3 seconds per bracket with a multiwave light-emitting diode curing light.
In the indirect bonding group, alginate was utilized to take impressions of the maxillary and mandibular arches, and hard dental stone was used to cast the dental models. Following the trimming and drying of the dental models dried, guidelines were drawn for vertical and horizontal bracket-positioning using a black pencil. The separating agent Al Cote (Dentsply Trubyte, York, Pennsylvania, USA) was administered onto the surfaces of the teeth surfaces using a brush, and the casts were left to dry. The same brackets used in the direct bonding technique were used. The composite adhesive was administered onto the base of the bracket, and the bracket was then placed onto the marked area on the tooth surface. The excess resin was carefully removed with a hand instrument. After positioning the bracket, the composite adhesive was polymerized with a multiwave light-emitting diode curing light. After positioning of the bracket on the transfer models, the composite adhesive was polymerized for 3 seconds, and a 2-layer transfer tray was prepared using translucent soft silicone and thermoformed rigid Essix Plus plastic. The base of the brackets in the transfer tray was sandblasted to remove the separating agent. A flowable composite adhesive was applied to the bracket bases, and the transfer tray was then seated on the arch segment. The composite adhesive was polymerized for 3 seconds before and after removing the transfer tray. Excessive composite adhesive remnants were then removed using a tungsten carbide bur in an air rotor instrument. For all of the patients included in the study, orthodontic treatment and recommendations for how to use toothpaste containing fluoride, how to brush their teeth and diet habits were also added to reduce the number of white spot lesions and provide better treatment. The QLF images of all patients who underwent direct and indirect bonding were taken by the same observer in the beginning of fixed orthodontic treatment (T0) and immediately after removal of the appliances (T1) at the end of the treatment period using a QLF-D Biluminator 2-camera system (Inspektor Research Systems, Amsterdam, The Netherlands).
- Being tested
- Quantitative Light-Induced Fluorescence, Direct bonding, Indirect bonding
- Keywords
- White Spot Lesions, Direct Bonding, Indirect Bonding, Quantitative Light-Induced Fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Light-Induced FluorescenceDevice
White spot lesion on the tooth surfaces detected with Quantitative Light-Induced Fluorescence Orthodontic Bonding.
Direct bondingProcedure or surgery
The patients in the direct bonding group received a bonding procedure with a conventional composite adhesive.
Indirect bondingProcedure or surgery
For the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Direct Bonding | Experimental | On the individual teeth Conventional bracket placement Use conventional composite Receives: 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 Receives: 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 Receives: Device: Quantitative Light-Induced Fluorescence; Procedure: Direct bonding; Procedure: Indirect bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 year
Secondary outcomes (1)
Quantitative white spot lesion amounts
The QLF method gives a quantitative result, it may be used efficiently for imaging of white spot lesion formation during or after orthodontic treatment.
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start28 Jul 2011
- Primary completion27 Nov 2013
- Study completion5 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesion of ToothStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Yağcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738839
- Sponsor's protocol ID
- TSA-11-3585
- Acronym
- QLF
- Status last verified
- Nov 2018
- First submitted
- 24 Oct 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 2816842van 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.
PubMed 10949838Sondhi 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.
PubMed 10194277Gorelick 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.
PubMed 6758594Baysal 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.
PubMed 27871699Yagci 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.
PubMed 26926020Tufekci 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.
PubMed 21208070Atilla 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.
PubMed 31375814
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence (QLF) Method Between Direct Bonding and Indirect Bonding Techniques in Adolescents
- ClinicalTrials.gov ID
- NCT03738839
- Acronym / sponsor ID
- QLF / TSA-11-3585
- Keywords
- White Spot Lesions, Direct Bonding, Indirect Bonding, Quantitative Light-Induced Fluorescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 28 Jul 2011 (actual)
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 5 Jan 2016 (actual)
- First posted
- 13 Nov 2018 (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 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.
Detailed description
This study was single center, one-blinded, 2-arm parallel, randomized clinical trial with a 1:1 allocation ratio. No changes were made to the protocol after trial commencement. Initially, 60 patients who had been referred to a tertiary clinic in Kayseri, Turkey for orthodontic treatment between October 2011 and June 2013 were assessed for eligibility by the clinicians (A.Y.). The inclusion criteria for the experiment groups in this study were 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. 60 patients were examined in the trial. Thirty-six patients were divided into groups with equal numbers of patients in each group. The study was completed with 31 patients. An analysis was performed on the 15 patients in the indirect bonding group and the 16 patients in the direct bonding group. Approval for the study was obtained from the Local Ethics Committee of the Faculty of Medicine at Erciyes University in Kayseri, Turkey (11-3585). Informed consent was obtained from all the patients included in the study. The consent was obtained from those over 18 years of age directly, and from the parents of those under 18 years of age. Standard treatment records, which are photographs, dental models and radiographs, were taken in the beginning of treatment and at the end of treatment from all patients included in the study. The patients were randomly allocated to 1 of 2 treatment groups: indirect bonding and direct bonding. In the direct bonding group, after the plaque structure on the teeth was cleaned with pumice and white elastic bur were etched with 37% phosphoric acid gel (3M-Dental Products, St Paul, Minnesota, USA) for 30 seconds, the teeth were rinsed and dried with oil-free compressed air for 15 seconds. After drying the enamel surface, the liquid primer Transbond XT (3M-Unitek, Monrovia, California, USA) was applied with a small brush and spread with oil-free compressed air. Pre-adjusted metal brackets which had values for the Roth prescription were then bonded using the conventional adhesive with a standard protocol and polymerized for 3 seconds per bracket with a multiwave light-emitting diode curing light.
In the indirect bonding group, alginate was utilized to take impressions of the maxillary and mandibular arches, and hard dental stone was used to cast the dental models. Following the trimming and drying of the dental models dried, guidelines were drawn for vertical and horizontal bracket-positioning using a black pencil. The separating agent Al Cote (Dentsply Trubyte, York, Pennsylvania, USA) was administered onto the surfaces of the teeth surfaces using a brush, and the casts were left to dry. The same brackets used in the direct bonding technique were used. The composite adhesive was administered onto the base of the bracket, and the bracket was then placed onto the marked area on the tooth surface. The excess resin was carefully removed with a hand instrument. After positioning the bracket, the composite adhesive was polymerized with a multiwave light-emitting diode curing light. After positioning of the bracket on the transfer models, the composite adhesive was polymerized for 3 seconds, and a 2-layer transfer tray was prepared using translucent soft silicone and thermoformed rigid Essix Plus plastic. The base of the brackets in the transfer tray was sandblasted to remove the separating agent. A flowable composite adhesive was applied to the bracket bases, and the transfer tray was then seated on the arch segment. The composite adhesive was polymerized for 3 seconds before and after removing the transfer tray. Excessive composite adhesive remnants were then removed using a tungsten carbide bur in an air rotor instrument. For all of the patients included in the study, orthodontic treatment and recommendations for how to use toothpaste containing fluoride, how to brush their teeth and diet habits were also added to reduce the number of white spot lesions and provide better treatment. The QLF images of all patients who underwent direct and indirect bonding were taken by the same observer in the beginning of fixed orthodontic treatment (T0) and immediately after removal of the appliances (T1) at the end of the treatment period using a QLF-D Biluminator 2-camera system (Inspektor Research Systems, Amsterdam, The Netherlands).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Random sequence generation was performed with a computerized random 1:1 allocation using block sizes of 4.
| Arm | Type | Receives |
|---|---|---|
| Direct Bonding | Experimental | Device: Quantitative Light-Induced Fluorescence, Procedure: Direct bondingOn the individual teeth Conventional bracket placement Use conventional composite |
| Indirect bonding | Experimental | Device: Quantitative Light-Induced Fluorescence, Procedure: Indirect bondingOn the dental stone models Indirect bracket placement Use flowable composite Use transfer trays |
| Quantitative Light-Induced Fluorescence | Active comparator | Device: Quantitative Light-Induced Fluorescence, Procedure: Direct bonding, Procedure: Indirect bondingUse special device and software Determination of the number and effect of caries |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- severe crowding,
- bad oral hygiene,
- presence of craniofacial anomalies,
- previous orthodontic, orthognathic or prosthetic treatment
- presence of congenital teeth deficiency, deciduous or extracted teeth
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 |
|---|---|---|
| Quantitative Light-Induced FluorescenceWhite spot lesion on the tooth surfaces detected with Quantitative Light-Induced Fluorescence Orthodontic Bonding. | Device | Direct Bonding, Indirect bonding, Quantitative Light-Induced Fluorescence |
| Direct bondingThe patients in the direct bonding group received a bonding procedure with a conventional composite adhesive. | Procedure or surgery | Direct Bonding, Quantitative Light-Induced Fluorescence |
| Indirect bondingFor the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive. | Procedure or surgery | Indirect bonding, Quantitative Light-Induced Fluorescence |
Primary outcome
White spot lesion incidence
Time frame: up to 2 year
In the indirect bonding technique group, less amount of white spot lesions are expected than the direct bonding technique in end of the treatment.
1 secondary outcome
Quantitative white spot lesion amounts
Time frame: up to 2 year
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 13 Nov 2018.
- Background: PubMed 2816842Ogaard 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.
- Background: PubMed 10949838van 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.
- Background: PubMed 10194277Sondhi 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.
- Results publication: PubMed 6758594Gorelick 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.
- Results publication: PubMed 27871699Baysal 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.
- Results publication: PubMed 26926020Yagci 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.
- Results publication: PubMed 21208070Tufekci 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.
- Derived from this study: PubMed 31375814Atilla 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Light-Induced Fluorescence, Direct bonding and Indirect bonding in people with White Spot Lesion of Tooth and Orthodontic Malocclusion, run by TC Erciyes University.
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 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
White spot lesion incidence (time frame: up to 2 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 NCT03738839, which also lists 8 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 13 Nov 2018.