Demineralization, ToothPhase 2NCT04342858
Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment
A Phase 2 study testing Fluoride Varnish, Fluoride Varnish with tricalcium phosphate and Oral health education in people with Demineralization, Tooth and Caries,Dental, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Treatment with fixed orthodontic appliances is often associated with pain, which poses great challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18 months or even longer in some cases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Demineralization, Tooth, Caries,Dental, White Spot Lesion
- What is being tested?
- Fluoride Varnish, Fluoride Varnish with tricalcium phosphate and Oral health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2017to 30 Jul 2021
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects about to undergo multi-bracketed fixed orthodontic treatment will be invited to participate in this study.
Who cannot join
- History of fixed orthodontic treatment
- Presence of any developmental defects of enamel (DDE) on labial surfaces of teeth
- Presence of any dental anomalies or direct/indirect labial restorations on teeth
- History of long-term antibiotic usage
- Presence of untreated cavitated lesions
- Plaque level greater than 25%
- Patients requiring complicated orthognathic surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial for Prevention of Enamel White Spot Lesions During Fixed Orthodontic Treatment
Treatment with fixed orthodontic appliances is often associated with pain, which poses great challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18 months or even longer in some cases. This prolonged vulnerability to plaque formation frequently leads to demineralization of teeth. There is also an increase in the number of plaque retentive sites due to the fixed appliances, leading to a rapid change in the bacterial composition of the dental plaque, particularly in the number of acidogenic bacteria. The resulting enamel decalcification is also known as white spot lesions (WSLs), which is an early sign of demineralization of enamel. Enamel WSLs (EWSLs) can be observed even as early as four weeks from the start of fixed orthodontic treatment. The occurrence of EWSLs adjacent to the orthodontic brackets ranges from 15 to 85%.
The incidence of EWSLs development is higher in orthodontic patients as compared to the development of similar lesions in non-orthodontic patients. These EWSLs are not aesthetically pleasing and is certainly unacceptable when it develops during fixed orthodontic treatment that is usually performed in patients who often seek such treatment to improve their aesthetics. Additionally, even if the outcome of fixed orthodontic treatment is superior from well-aligned teeth, aesthetics can be greatly compromised with EWSLs. Therefore, the prevention of such lesions is an important concern for orthodontists.
Though professionally applied topical fluoride varnish helps in remineralization of EWSLs, an adequate supply of calcium and phosphate ions is essential for remineralization. Therefore, EWSLs on maxillary teeth could be prevented and remineralized by the use of advanced novel topical fluoride varnish with added calcium and phosphate-based delivery system.
Read the detailed description
Fluoride is proven caries preventive and therapeutic agent. It helps in the remineralization of early enamel caries lesions and subsequently increases its resistance to dissolution by acids produced by cariogenic microflora. Topical fluoride varnish was introduced in the 1960s. The Food and Drug Administration (FDA) in the USA approved the use of fluoride varnishes for dentistry in 1994 and presently fluoride varnish is the most commonly used professionally applied topical fluoride agent. The most popular topical fluoride varnish is Duraphat®, which contains 5% NaF varnish (2.2% Fluoride). The greatest advantage of topical fluoride varnish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows the continuous release of fluoride ions into enamel, dentine, plaque, and saliva. Additionally, the application of topical fluoride varnish is a simple procedure and does not require great patient co-operation. Topical fluoride varnish application has been reported to exhibit substantial caries inhibiting effect in both permanent and primary teeth.
Among the various forms of fluoride products, such as gels, varnishes, foams, mouth- rinses, and toothpastes, varnishes do not rely on patient compliance and cooperation. The major advantage of varnishes is high retention followed by gradual release of fluoride over an extended time period, which leads to low concentrations in the liquid plaque-enamel interface. The use of fluoride diminishes demineralization and promotes remineralization, thereby balancing the process of caries formation. A recent Cochrane review has revealed moderate evidence for the prevention of EWSLs during fixed orthodontic treatment by fluoride varnish application every six weeks at the time of orthodontic review, but this finding is based on a single study. Therefore, the quality of the evidence found is moderate and the review recommendations state that additional well- conducted research is required in this area.
Caries preventive and inhibiting effect of topical fluoride therapy depends on an adequate supply of calcium and phosphate ions. Though calcium and phosphate ions are supplied naturally by saliva, the concentration of such ions is low (even lower in patients suffering from reduced salivary flow). Low concentration of salivary calcium and phosphate ions leads to a mineral deposition only at the surface of the enamel as a result of a low ion concentration gradient. The deposition of minerals at the surface of enamel alone may not improve the structural properties of the deeper part of the early-stage or incipient caries lesions. This has led to the introduction of calcium phosphate-based delivery systems containing high concentrations of calcium phosphate such as tri-calcium phosphate (TCP).
Tri-calcium phosphate (TCP) is a product resulting from ball milling beta-tri-calcium phosphate with sodium lauryl sulphate. ClinproTM white varnish (3M ESPE, St Paul, MN, USA), which contains TCP and NaF, is a commercially available topical fluoride varnish, which claims that the protective fumaric acid barrier facilitates co-existence of calcium and fluoride ions, however, during storage, the unwanted reaction between the ions is prevented. The protective barrier breaks upon contact with saliva, releasing the ions for effective remineralization of the tooth. At present there is no clinical study to prove the superior EWSLs-preventive effect of this newer NaF varnish with TCP when compared to conventional topical NaF varnish in patients undergoing fixed orthodontic treatment.
- Conditions
- Demineralization, Tooth, Caries,Dental, White Spot Lesion
- Being tested
- Fluoride Varnish, Fluoride Varnish with tricalcium phosphate, Oral health education
- Keywords
- orthodontics, demineralizatiion, fluoride, Diagnodent
- Medical subject headings
- Tooth Demineralization, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDrug
Also called 5% Sodium fluoride varnish
Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK
Fluoride Varnish with tricalcium phosphateDrug
Also called 5% Sodium fluoride varnish containing tri-calcium phosphate
Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA
Oral health educationOther
Also called Oral hygiene instructions
Standard oral hygiene instructions every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | Control will receive standard oral hygiene instructions (OHI every three months) Receives: Other: Oral health education |
| Standard of care + Fluoride varnish | Active comparator | Intervention 1 will receive standard OHI and application of topical fluoride varnish containing 5% NaF (Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK) every three months Receives: Drug: Fluoride Varnish |
| Standard of care + Fluoride varnish with Tricalcium phosphate | Experimental | Intervention 2 will receive standard OHI and application of topical fluoride varnish containing 5% NaF + TCP (Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA) every three months Receives: Drug: Fluoride Varnish with tricalcium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically).
The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome.
Measured: 24 months
Change in Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically).
The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome
Measured: 24 months
Change in Laser fluoroscence values (Objective criteria)
Changes in mean DIAGNOdent scores among three study groups. The DIAGNOdent values (or laser fluorescence values) are visible on the device as digital readings from 0 to 99 with higher readings representing poor outcomes and lower readings representing good outcomes.
Measured: 24 months
Secondary outcomes (9)
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically)
Measured: 6 months
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically)
Measured: 12 months
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically)
Measured: 18 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically)
Measured: 6 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically)
Measured: 12 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically)
Measured: 18 months
Laser fluoroscence evaluation (Objective criteria)
Mean DIAGNOdent scores among three study groups
Measured: 6 months
Laser fluoroscence evaluation (Objective criteria)
Mean DIAGNOdent scores among three study groups
Measured: 12 months
Laser fluoroscence evaluation (Objective criteria)
Mean DIAGNOdent scores among three study groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start15 Sep 2017
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demineralization, ToothStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial with three parallel groups. In the proposed study, individual participants, and not parts of the mouth, will serve as the unit of randomization. This approach unlike a split-mouth design will eliminate the problems of cross-contamination.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia KY Yiu, MDS, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342858
- Sponsor's protocol ID
- Version no.3; 27th Nov'17
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Management Plan (DMP) has been submitted to the university repository and final data will be deposited to the university.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial for Prevention of Enamel White Spot Lesions During Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04342858
- Acronym / sponsor ID
- Version no.3; 27th Nov'17
- Conditions
- Demineralization, Tooth, Caries,Dental, White Spot Lesion
- Keywords
- orthodontics, demineralizatiion, fluoride, Diagnodent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 13 Apr 2020 (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.
Treatment with fixed orthodontic appliances is often associated with pain, which poses great challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18 months or even longer in some cases. This prolonged vulnerability to plaque formation frequently leads to demineralization of teeth. There is also an increase in the number of plaque retentive sites due to the fixed appliances, leading to a rapid change in the bacterial composition of the dental plaque, particularly in the number of acidogenic bacteria. The resulting enamel decalcification is also known as white spot lesions (WSLs), which is an early sign of demineralization of enamel. Enamel WSLs (EWSLs) can be observed even as early as four weeks from the start of fixed orthodontic treatment. The occurrence of EWSLs adjacent to the orthodontic brackets ranges from 15 to 85%.
The incidence of EWSLs development is higher in orthodontic patients as compared to the development of similar lesions in non-orthodontic patients. These EWSLs are not aesthetically pleasing and is certainly unacceptable when it develops during fixed orthodontic treatment that is usually performed in patients who often seek such treatment to improve their aesthetics. Additionally, even if the outcome of fixed orthodontic treatment is superior from well-aligned teeth, aesthetics can be greatly compromised with EWSLs. Therefore, the prevention of such lesions is an important concern for orthodontists.
Though professionally applied topical fluoride varnish helps in remineralization of EWSLs, an adequate supply of calcium and phosphate ions is essential for remineralization. Therefore, EWSLs on maxillary teeth could be prevented and remineralized by the use of advanced novel topical fluoride varnish with added calcium and phosphate-based delivery system.
Detailed description
Fluoride is proven caries preventive and therapeutic agent. It helps in the remineralization of early enamel caries lesions and subsequently increases its resistance to dissolution by acids produced by cariogenic microflora. Topical fluoride varnish was introduced in the 1960s. The Food and Drug Administration (FDA) in the USA approved the use of fluoride varnishes for dentistry in 1994 and presently fluoride varnish is the most commonly used professionally applied topical fluoride agent. The most popular topical fluoride varnish is Duraphat®, which contains 5% NaF varnish (2.2% Fluoride). The greatest advantage of topical fluoride varnish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows the continuous release of fluoride ions into enamel, dentine, plaque, and saliva. Additionally, the application of topical fluoride varnish is a simple procedure and does not require great patient co-operation. Topical fluoride varnish application has been reported to exhibit substantial caries inhibiting effect in both permanent and primary teeth.
Among the various forms of fluoride products, such as gels, varnishes, foams, mouth- rinses, and toothpastes, varnishes do not rely on patient compliance and cooperation. The major advantage of varnishes is high retention followed by gradual release of fluoride over an extended time period, which leads to low concentrations in the liquid plaque-enamel interface. The use of fluoride diminishes demineralization and promotes remineralization, thereby balancing the process of caries formation. A recent Cochrane review has revealed moderate evidence for the prevention of EWSLs during fixed orthodontic treatment by fluoride varnish application every six weeks at the time of orthodontic review, but this finding is based on a single study. Therefore, the quality of the evidence found is moderate and the review recommendations state that additional well- conducted research is required in this area.
Caries preventive and inhibiting effect of topical fluoride therapy depends on an adequate supply of calcium and phosphate ions. Though calcium and phosphate ions are supplied naturally by saliva, the concentration of such ions is low (even lower in patients suffering from reduced salivary flow). Low concentration of salivary calcium and phosphate ions leads to a mineral deposition only at the surface of the enamel as a result of a low ion concentration gradient. The deposition of minerals at the surface of enamel alone may not improve the structural properties of the deeper part of the early-stage or incipient caries lesions. This has led to the introduction of calcium phosphate-based delivery systems containing high concentrations of calcium phosphate such as tri-calcium phosphate (TCP).
Tri-calcium phosphate (TCP) is a product resulting from ball milling beta-tri-calcium phosphate with sodium lauryl sulphate. ClinproTM white varnish (3M ESPE, St Paul, MN, USA), which contains TCP and NaF, is a commercially available topical fluoride varnish, which claims that the protective fumaric acid barrier facilitates co-existence of calcium and fluoride ions, however, during storage, the unwanted reaction between the ions is prevented. The protective barrier breaks upon contact with saliva, releasing the ions for effective remineralization of the tooth. At present there is no clinical study to prove the superior EWSLs-preventive effect of this newer NaF varnish with TCP when compared to conventional topical NaF varnish in patients undergoing fixed orthodontic treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized controlled trial with three parallel groups. In the proposed study, individual participants, and not parts of the mouth, will serve as the unit of randomization. This approach unlike a split-mouth design will eliminate the problems of cross-contamination.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Other: Oral health educationControl will receive standard oral hygiene instructions (OHI every three months) |
| Standard of care + Fluoride varnish | Active comparator | Drug: Fluoride VarnishIntervention 1 will receive standard OHI and application of topical fluoride varnish containing 5% NaF (Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK) every three months |
| Standard of care + Fluoride varnish with Tricalcium phosphate | Experimental | Drug: Fluoride Varnish with tricalcium phosphateIntervention 2 will receive standard OHI and application of topical fluoride varnish containing 5% NaF + TCP (Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA) every three months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects about to undergo multi-bracketed fixed orthodontic treatment will be invited to participate in this study.
Key exclusion criteria (7 listed)
- History of fixed orthodontic treatment
- Presence of any developmental defects of enamel (DDE) on labial surfaces of teeth
- Presence of any dental anomalies or direct/indirect labial restorations on teeth
- History of long-term antibiotic usage
- Presence of untreated cavitated lesions
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 |
|---|---|---|
| Fluoride VarnishAlso: 5% Sodium fluoride varnishDuraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK | Drug | Standard of care + Fluoride varnish |
| Fluoride Varnish with tricalcium phosphateAlso: 5% Sodium fluoride varnish containing tri-calcium phosphateClinpro white varnishTM, 3M ESPE, St Paul, MN, USA | Drug | Standard of care + Fluoride varnish with Tricalcium phosphate |
| Oral health educationAlso: Oral hygiene instructionsStandard oral hygiene instructions every 3 months | Other | Standard of care |
Primary outcome
Change in Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
Time frame: 24 months
Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome.
Change in Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
Time frame: 24 months
Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome
Change in Laser fluoroscence values (Objective criteria)
Time frame: 24 months
Changes in mean DIAGNOdent scores among three study groups. The DIAGNOdent values (or laser fluorescence values) are visible on the device as digital readings from 0 to 99 with higher readings representing poor outcomes and lower readings representing good outcomes.
9 secondary outcomes
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
Time frame: 6 months
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
Time frame: 12 months
Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)
Time frame: 18 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
Time frame: 6 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
Time frame: 12 months
Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)
Time frame: 18 months
Laser fluoroscence evaluation (Objective criteria)
Time frame: 6 months
Laser fluoroscence evaluation (Objective criteria)
Time frame: 12 months
Laser fluoroscence evaluation (Objective criteria)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No. Data Management Plan (DMP) has been submitted to the university repository and final data will be deposited to the university.
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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.
Cynthia KY Yiu, MDS, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoride Varnish, Fluoride Varnish with tricalcium phosphate and Oral health education in people with Demineralization, Tooth and Caries,Dental, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 7 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2020.