Dental CariesPhase 2/3NCT00495495
Healozone Study to Evaluate the Safety and Efficacy of the Use of Ozone for Management of Dental Caries
A Phase 2/3 study testing Ozone treatment in people with Dental Caries, run by Indiana University at 3 sites in United States.
Trial summary
Caries means demineralization with the formation of cavities and pulp symptoms and necrosis as an end result. The acids in the mouth are mainly produced by oral bacteria like Streptococcus mutans from bacterial biofilms adhering to the tooth. Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Ozone treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be eligible for study participation, subjects had to:
- 1. provide written informed consent, HIPAA authorization and medical history information prior to their participation; 2. be between the ages of 10 and 40 years of age; 3. if female and of childbearing potential, agree to:
- a urine pregnancy test, which must be negative;
- use one form of medically accepted contraceptive measures which include oral contraceptives, condom, or diaphragm with spermicide, Intra Uterine Device (IUD), Depo-Provera, Norplant during the study and for at least 30 days after the last treatment. (Females who are post menopausal, i.e. amenorrhea for the previous 12 months, or surgically sterile may be included.) 4. be in good general health as evidenced by a review of the medical history; 5. have good oral health; 6. agree to comply with all subjects' responsibilities as stated in the protocol (e.g. attendance at appointments, turning off of cell phone during appointment, etc.); and 7. have two posterior (molar or premolar) teeth with active fissure caries as defined by ICDAS severity score between 1 and 4, a caries lesion activity score of 2, and with radiographic evidence indicating that there is no extension past the dentinal enamel junction. Lesions within the same subject ideally should have the same ICDAS criterion; however, the following deviations will be acceptable - teeth with ICDAS criterion 1 paired with a 2, and a 3 paired with a 4.
Who cannot join
- Any of the following excluded subjects from participating:
- a medical condition that requires antibiotic therapy prior to dental work;
- any medical condition that could be expected to interfere with the subject's safety, such as a pacemaker or similar powered implant;
- selected study teeth with occlusal restorations, sealants, carious lesions extending into dentin, hypomineralization or fluorosis;
- generalized severe gingivitis or gross unrestored caries;
- orthodontic appliances that interfere with access to selected study teeth;
- pregnant or nursing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
State University of New York at Buffalo, School of Dental Medicine
Buffalo, New York, 14214
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
Official title: A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries
Caries means demineralization with the formation of cavities and pulp symptoms and necrosis as an end result. The acids in the mouth are mainly produced by oral bacteria like Streptococcus mutans from bacterial biofilms adhering to the tooth. Ozone has been shown to have a very strong bactericidal effect on bacteria causing dental caries. Baysan et al reported that there was a statistically significant reduction of streptococci in root caries lesions and saliva samples after ozone application. The positive clinical effect of ozone with respect to arresting caries progression and the remineralization of caries has been shown in vitro and in vivo. In an in vivo study, Baysan and Lynch found that the application of ozone resulted in a significant reduction of bacterial contamination as well as a reduction in size and severity of root caries lesions. In a subsequent study, Baysan and Lynch reported that the severity of root caries lesions was significantly reduced after ozone application as measured by electrical conductance and laser fluorescence. In several studies, the caries reducing effect of ozone was measured with biochemical methods in root surface caries lesions, the biofilm and saliva after ozone application. See Citation section for references.
The objectives of this multi-center clinical study were to determine: (1) the effectiveness of the HealOzone in stopping the progression of fissure caries; and (2) the oral soft tissue safety of the ozone system.
Read the detailed description
The proposed study was designed as a twelve-month, multi-center, double-blind, randomized controlled clinical study involving 394 subjects with 788 lesions. There were three sites participating in this trial: Indiana University School of Dentistry (lead site), Tufts University School of Dental Medicine, and SUNY School of Dental Medicine. Each site submitted a version of the protocol to their respective Institutional Review Board ("IRB") that incorporated the specific institutional and state guidelines and regulations applicable to that site.
The two treatment regimens were: (a) placebo treatment and (b) experimental ozone treatment. Selected subjects had to have at least two teeth with similar stages of early active fissure caries. The selection of the study teeth was determined by a review of the visual examination, including the ICDAS severity score and the caries lesion activity score, conducted at the screening visit, in conjunction with the bitewing radiographs. The decision whether a tooth was to be treated with ozone or receive placebo treatment was made randomly.
All clinical personnel involved in the clinical examinations and treatment application were trained at the primary site prior to the initiation of the trial both in the use of the device, and in how to identify the signs and symptoms of ozone toxicity and in how to provide the appropriate medical response should any of these signs or symptoms be observed.
All qualified subjects received the following:
- Professional dental cleaning and scaling at the Screening Visit (or separate visit prior to baseline visit and after completing the study at 12 months.
- Diagnostic procedures:
- Clinical visual examination (utilizing the International Caries Detection and Assessment System [ICDAS] severity scoring)
- Clinical visual/tactile assessment of caries lesion activity
- Bitewing x-rays
- Laser fluorescence measurement (utilizing the DIAGNOdent, KaVo)
- Treatment Regimen:
Using a split-mouth design, the assigned investigational treatment regimen was administered on the two selected study teeth at the baseline, and at the three-, six- and nine-month appointments.
After three, six, nine and twelve months, the diagnostic procedures were repeated with the exception of bitewing x-rays, which were only repeated at the twelve-month exam (unless the examining dentist determined that x-rays also were needed at the six- or nine-month visit to confirm whether dentinal caries were present). In addition, optional digital photographs were taken at the Boston site of selected study teeth to document clinical changes over the study period.
If a selected study tooth progressed from an initial caries lesion to a more advanced lesion, which in the judgment of the examining dentist required restorative intervention, the tooth was restored at no cost to the subject and the lesion was recorded as 'progression from baseline' at any remaining examinations. The subject was eligible to remain in the study.
Subjects received a thorough dental cleaning and scaling and topical fluoride treatment at the conclusion of the twelve-month examination.
The primary efficacy parameter will be the ICDAS severity value. The severity criteria used in the ICDAS diagnostic system are as follows:
0 = Sound tooth surface.
- = First visual change in enamel.
- = Distinct visual change in enamel.
- = Localized enamel breakdown due to caries with no visible dentin.
- = Underlying dark shadow from dentin, with or without localized enamel breakdown.
- = Distinct cavity with visible dentin.
- = Extensive distinct cavity with visible dentin.
The secondary efficacy parameters will be measured by:
Caries Lesion Activity score:
- = Inactive - surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.
- = Active lesion - surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface.
Radiographic Changes:
The occlusal surface of study teeth will be evaluated using the following scale:
Lesion presence: yes /no
Lesion depth:
E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure
Laser fluorescence measurement:
DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.
- Conditions
- Dental Caries
- Being tested
- Ozone treatment, Placebo treatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone treatmentDevice
Also called HealOzone unit
Ozone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits.
Placebo treatmentDevice
Placebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits.
| Study group | Role | What they receive |
|---|---|---|
| Ozone treatment | Experimental | Ozone treatment of randomly selected study tooth for 60 seconds Receives: Device: Ozone treatment |
| Placebo, no ozone | Placebo comparator | Placebo treatment (no ozone) of randomly selected study tooth for 60 seconds. Receives: Device: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICDAS Severity Value
Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:
0 = Sound tooth surface.
- = First visual change in enamel.
- = Distinct visual change in enamel.
- = Localized enamel breakdown due to caries with no visible dentin.
- = Underlying dark shadow from dentin, with or without localized enamel breakdown.
- = Distinct cavity with visible dentin.
- = Extensive distinct cavity with visible dentin.
Measured: Baseline and One Year
Secondary outcomes (4)
Change in Caries Lesion Activity
Change in caries lesion activity at One Year. All teeth were considered Active at Baseline
Caries Lesion Activity score:
- = Inactive - surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.
- = Active lesion - surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface.
Measured: Baseline and one year
Progression of Radiographic Scores at 12 Months
Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from "no" to "yes" or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:
Lesion presence: yes /no
Lesion depth:
E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure
Measured: one year
Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)
The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.
Measured: one year
Laser Fluorescence Progression-12 Month (Increase at Least 10)
The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Indiana 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University School of Dental Medicine, State University of New York at Buffalo
- Responsible party
- Sponsor
- Investigators
- Domenick T Zero, DDS MS, Principal investigator, Indiana UniversityAthena Papas, DMD, PhD, Principal investigator, Tufts University School of Dental MedicineSebastian Ciancio, DDS, PhD, Principal investigator, SUNY School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495495
- Sponsor's protocol ID
- 07-D-187
- Other IDs
- IDE G50008, Clinical Trials. gov
- Status last verified
- Feb 2015
- First submitted
- 1 Jul 2007
- Last updated
- 20 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Ozone for the Management of Fissure Caries
- ClinicalTrials.gov ID
- NCT00495495
- Acronym / sponsor ID
- 07-D-187
- Conditions
- Dental Caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Tufts University School of Dental Medicine, State University of New York at Buffalo
- Study start
- Feb 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Posted 23 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caries means demineralization with the formation of cavities and pulp symptoms and necrosis as an end result. The acids in the mouth are mainly produced by oral bacteria like Streptococcus mutans from bacterial biofilms adhering to the tooth. Ozone has been shown to have a very strong bactericidal effect on bacteria causing dental caries. Baysan et al reported that there was a statistically significant reduction of streptococci in root caries lesions and saliva samples after ozone application. The positive clinical effect of ozone with respect to arresting caries progression and the remineralization of caries has been shown in vitro and in vivo. In an in vivo study, Baysan and Lynch found that the application of ozone resulted in a significant reduction of bacterial contamination as well as a reduction in size and severity of root caries lesions. In a subsequent study, Baysan and Lynch reported that the severity of root caries lesions was significantly reduced after ozone application as measured by electrical conductance and laser fluorescence. In several studies, the caries reducing effect of ozone was measured with biochemical methods in root surface caries lesions, the biofilm and saliva after ozone application. See Citation section for references.
The objectives of this multi-center clinical study were to determine: (1) the effectiveness of the HealOzone in stopping the progression of fissure caries; and (2) the oral soft tissue safety of the ozone system.
Detailed description
The proposed study was designed as a twelve-month, multi-center, double-blind, randomized controlled clinical study involving 394 subjects with 788 lesions. There were three sites participating in this trial: Indiana University School of Dentistry (lead site), Tufts University School of Dental Medicine, and SUNY School of Dental Medicine. Each site submitted a version of the protocol to their respective Institutional Review Board ("IRB") that incorporated the specific institutional and state guidelines and regulations applicable to that site.
The two treatment regimens were: (a) placebo treatment and (b) experimental ozone treatment. Selected subjects had to have at least two teeth with similar stages of early active fissure caries. The selection of the study teeth was determined by a review of the visual examination, including the ICDAS severity score and the caries lesion activity score, conducted at the screening visit, in conjunction with the bitewing radiographs. The decision whether a tooth was to be treated with ozone or receive placebo treatment was made randomly.
All clinical personnel involved in the clinical examinations and treatment application were trained at the primary site prior to the initiation of the trial both in the use of the device, and in how to identify the signs and symptoms of ozone toxicity and in how to provide the appropriate medical response should any of these signs or symptoms be observed.
All qualified subjects received the following:
- Professional dental cleaning and scaling at the Screening Visit (or separate visit prior to baseline visit and after completing the study at 12 months.
- Diagnostic procedures:
- Clinical visual examination (utilizing the International Caries Detection and Assessment System [ICDAS] severity scoring)
- Clinical visual/tactile assessment of caries lesion activity
- Bitewing x-rays
- Laser fluorescence measurement (utilizing the DIAGNOdent, KaVo)
- Treatment Regimen:
Using a split-mouth design, the assigned investigational treatment regimen was administered on the two selected study teeth at the baseline, and at the three-, six- and nine-month appointments.
After three, six, nine and twelve months, the diagnostic procedures were repeated with the exception of bitewing x-rays, which were only repeated at the twelve-month exam (unless the examining dentist determined that x-rays also were needed at the six- or nine-month visit to confirm whether dentinal caries were present). In addition, optional digital photographs were taken at the Boston site of selected study teeth to document clinical changes over the study period.
If a selected study tooth progressed from an initial caries lesion to a more advanced lesion, which in the judgment of the examining dentist required restorative intervention, the tooth was restored at no cost to the subject and the lesion was recorded as 'progression from baseline' at any remaining examinations. The subject was eligible to remain in the study.
Subjects received a thorough dental cleaning and scaling and topical fluoride treatment at the conclusion of the twelve-month examination.
The primary efficacy parameter will be the ICDAS severity value. The severity criteria used in the ICDAS diagnostic system are as follows:
0 = Sound tooth surface.
- = First visual change in enamel.
- = Distinct visual change in enamel.
- = Localized enamel breakdown due to caries with no visible dentin.
- = Underlying dark shadow from dentin, with or without localized enamel breakdown.
- = Distinct cavity with visible dentin.
- = Extensive distinct cavity with visible dentin.
The secondary efficacy parameters will be measured by:
Caries Lesion Activity score:
- = Inactive - surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.
- = Active lesion - surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface.
Radiographic Changes:
The occlusal surface of study teeth will be evaluated using the following scale:
Lesion presence: yes /no
Lesion depth:
E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure
Laser fluorescence measurement:
DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone treatment | Experimental | Device: Ozone treatmentOzone treatment of randomly selected study tooth for 60 seconds |
| Placebo, no ozone | Placebo comparator | Device: Placebo treatmentPlacebo treatment (no ozone) of randomly selected study tooth for 60 seconds. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 1. provide written informed consent, HIPAA authorization and medical history information prior to their participation; 2. be between the ages of 10 and 40 years of age; 3. if female and of childbearing potential, agree to:
- a urine pregnancy test, which must be negative;
- use one form of medically accepted contraceptive measures which include oral contraceptives, condom, or diaphragm with spermicide, Intra Uterine Device (IUD), Depo-Provera, Norplant during the study and for at least 30 days after the last treatment. (Females who are post menopausal, i.e. amenorrhea for the previous 12 months, or surgically sterile may be included.) 4. be in good general health as evidenced by a review of the medical history; 5. have good oral health; 6. agree to comply with all subjects' responsibilities as stated in the protocol (e.g. attendance at appointments, turning off of cell phone during appointment, etc.); and 7. have two posterior (molar or premolar) teeth with active fissure caries as defined by ICDAS severity score between 1 and 4, a caries lesion activity score of 2, and with radiographic evidence indicating that there is no extension past the dentinal enamel junction. Lesions within the same subject ideally should have the same ICDAS criterion; however, the following deviations will be acceptable - teeth with ICDAS criterion 1 paired with a 2, and a 3 paired with a 4.
Key exclusion criteria (7 listed)
- a medical condition that requires antibiotic therapy prior to dental work;
- any medical condition that could be expected to interfere with the subject's safety, such as a pacemaker or similar powered implant;
- selected study teeth with occlusal restorations, sealants, carious lesions extending into dentin, hypomineralization or fluorosis;
- generalized severe gingivitis or gross unrestored caries;
- orthodontic appliances that interfere with access to selected study 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 |
|---|---|---|
| Ozone treatmentAlso: HealOzone unitOzone treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three, Six and Nine-Month visits. | Device | Ozone treatment |
| Placebo treatmentPlacebo treatment applied to randomly selected tooth for a period of 60 seconds at Baseline, Three-, Six- and Nine-Month visits. | Device | Placebo, no ozone |
Primary outcome
ICDAS Severity Value
Time frame: Baseline and One Year
Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows: 0 = Sound tooth surface. 1. = First visual change in enamel. 2. = Distinct visual change in enamel. 3. = Localized enamel breakdown due to caries with no visible dentin. 4. = Underlying dark shadow from dentin, with or without localized enamel breakdown. 5. = Distinct cavity with visible dentin. 6. = Extensive distinct cavity with visible dentin.
4 secondary outcomes
Change in Caries Lesion Activity
Time frame: Baseline and one year
Progression of Radiographic Scores at 12 Months
Time frame: one year
Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)
Time frame: one year
Laser Fluorescence Progression-12 Month (Increase at Least 10)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Domenick T Zero, DDS MS principal investigator
Indiana University
Athena Papas, DMD, PhD principal investigator
Tufts University School of Dental Medicine
Sebastian Ciancio, DDS, PhD principal investigator
SUNY School of Dental Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ozone treatment in people with Dental Caries, run by Indiana University at 3 sites in United States.
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 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: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ICDAS Severity Value (time frame: Baseline and One Year). 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 20 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.