CariesNCT01665911
An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
A study testing 1.5 mg Sodium Fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk and 3 mg sodium fluoride in 100 ml milk in people with Caries, run by Frank Lippert at 1 site in United States.
Trial summary
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- 1.5 mg Sodium Fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk and 3 mg sodium fluoride in 100 ml milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
- be between 18 and 80 years old and in general good health;
- willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
- wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
- be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
- be in good dental health with no active caries or periodontal disease;
Show all 9Show fewer
- agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
- have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).
- Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening
Who cannot join
- be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.
- have any medical condition that could be expected to interfere with the subject's safety during the study period;
- demonstrate an inability to comply with study procedures;
- have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
- be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
- be lactose intolerant or have known allergy or intolerance to milk or milk products
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute, Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.
Read the detailed description
The evidence of milk fluoridation as a public health measure in caries prevention has been demonstrated in many clinical studies. While these data are encouraging, the main focus now should be on the optimization of milk fluoride programs. This protocol will concentrate on the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral caries test or model (ICT). The ICT is an established model which features the use of gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque stagnation area. After subject has been consented and enrolled in the study per the inclusion/exclusion criteria, two to three days following a dental cleaning, two partially demineralized specimens will be placed in the buccal flange area of the subject's mandibular partial denture. During each of the five, three-week test periods, subjects will drink their assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk) timed minutes, wearing their mandibular partial dentures 24 hours a day during the test period. Fluoride free toothpaste will be used two to three days before and continuously during each treatment period. After each three-week test period, the two partially demineralized specimens will be removed from the subject's partial denture and analyzed using the surface microhardness test. Mineral content change (as percentage of surface microhardness recovery) in these artificially induced incipient enamel lesions will be the primary outcome variable. Each subject (n = 28) will serve as his or her own control.
- Conditions
- Caries
- Being tested
- 1.5 mg Sodium Fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk, Non-fluoridated milk, 200 ml
- Keywords
- Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 mg Sodium Fluoride in 100 ml milkDrug
Also called sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
1.5 mg sodium fluoride in 200 ml milkDrug
Also called sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 100 ml milkDrug
Also called sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
3 mg sodium fluoride in 200 ml milkDrug
Also called sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Non-fluoridated milk, 200 mlOther
Also called Kroger Nonfat Dry Milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk Receives: Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml |
| Arm 2 | Other | non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk Receives: Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml |
| Arm 3 | Other | non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk Receives: Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml |
| Arm 4 | Other | non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk Receives: Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml |
| Arm 5 | Active comparator | non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk Receives: Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
- surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:
- SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).
Measured: Three Weeks per each of five arms
Secondary outcomes (2)
% Acid Resistance Score Per Each of Five Arms
% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
Measured: Three Weeks per each of five arms
Enamel Fluoride Uptake Per Each of Five Arms
Enamel fluoride uptake is a measure of fluoridation of a caries lesion
Measured: Three Weeks per each of five arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionJun 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Lippert
- Sponsor type
- University, hospital or other
- Collaborators
- The Borrow Foundation
- Responsible party
- Sponsor-investigator, Frank Lippert, Indiana University
- Investigators
- Frank Lippert, PhD, Principal investigator, Indiana UniversityDomenick Zero, DDS, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665911
- Sponsor's protocol ID
- 12-I-086
- Status last verified
- Feb 2015
- First submitted
- 7 Aug 2012
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lippert F, Martinez-Mier EA, Zero DT. An in situ caries study on the interplay between fluoride dose and concentration in milk. J Dent. 2014 Jul;42(7):883-90. doi: 10.1016/j.jdent.2014.01.010. Epub 2014 Feb 7.
PubMed 24513113
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
- ClinicalTrials.gov ID
- NCT01665911
- Acronym / sponsor ID
- 12-I-086
- Conditions
- Caries
- Keywords
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Frank LippertUniversity, hospital or other
- Collaborators
- The Borrow Foundation
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.
Detailed description
The evidence of milk fluoridation as a public health measure in caries prevention has been demonstrated in many clinical studies. While these data are encouraging, the main focus now should be on the optimization of milk fluoride programs. This protocol will concentrate on the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral caries test or model (ICT). The ICT is an established model which features the use of gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque stagnation area. After subject has been consented and enrolled in the study per the inclusion/exclusion criteria, two to three days following a dental cleaning, two partially demineralized specimens will be placed in the buccal flange area of the subject's mandibular partial denture. During each of the five, three-week test periods, subjects will drink their assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk) timed minutes, wearing their mandibular partial dentures 24 hours a day during the test period. Fluoride free toothpaste will be used two to three days before and continuously during each treatment period. After each three-week test period, the two partially demineralized specimens will be removed from the subject's partial denture and analyzed using the surface microhardness test. Mineral content change (as percentage of surface microhardness recovery) in these artificially induced incipient enamel lesions will be the primary outcome variable. Each subject (n = 28) will serve as his or her own control.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: 1.5 mg Sodium Fluoride in 100 ml milk, Drug: 1.5 mg sodium fluoride in 200 ml milk, Drug: 3 mg sodium fluoride in 100 ml milk, Drug: 3 mg sodium fluoride in 200 ml milk, Other: Non-fluoridated milk, 200 mlnon-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk |
| Arm 2 | Other | Drug: 1.5 mg Sodium Fluoride in 100 ml milk, Drug: 1.5 mg sodium fluoride in 200 ml milk, Drug: 3 mg sodium fluoride in 100 ml milk, Drug: 3 mg sodium fluoride in 200 ml milk, Other: Non-fluoridated milk, 200 mlnon-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk |
| Arm 3 | Other | Drug: 1.5 mg Sodium Fluoride in 100 ml milk, Drug: 1.5 mg sodium fluoride in 200 ml milk, Drug: 3 mg sodium fluoride in 100 ml milk, Drug: 3 mg sodium fluoride in 200 ml milk, Other: Non-fluoridated milk, 200 mlnon-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk |
| Arm 4 | Other | Drug: 1.5 mg Sodium Fluoride in 100 ml milk, Drug: 1.5 mg sodium fluoride in 200 ml milk, Drug: 3 mg sodium fluoride in 100 ml milk, Drug: 3 mg sodium fluoride in 200 ml milk, Other: Non-fluoridated milk, 200 mlnon-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk |
| Arm 5 | Active comparator | Drug: 1.5 mg Sodium Fluoride in 100 ml milk, Drug: 1.5 mg sodium fluoride in 200 ml milk, Drug: 3 mg sodium fluoride in 100 ml milk, Drug: 3 mg sodium fluoride in 200 ml milk, Other: Non-fluoridated milk, 200 mlnon-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
- be between 18 and 80 years old and in general good health;
- willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
- wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
- be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
Key exclusion criteria (6 listed)
- be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.
- have any medical condition that could be expected to interfere with the subject's safety during the study period;
- demonstrate an inability to comply with study procedures;
- have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
- be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
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 |
|---|---|---|
| 1.5 mg Sodium Fluoride in 100 ml milkAlso: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milkEach subject will use this product during one of the five treatment periods in the crossover study design. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| 1.5 mg sodium fluoride in 200 ml milkAlso: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milkEach subject will use this product during one of the five treatment periods in the crossover study design. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| 3 mg sodium fluoride in 100 ml milkAlso: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milkEach subject will use this product during one of the five treatment periods in the crossover study design. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| 3 mg sodium fluoride in 200 ml milkAlso: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milkEach subject will use this product during one of the five treatment periods in the crossover study design | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| Non-fluoridated milk, 200 mlAlso: Kroger Nonfat Dry MilkEach subject will use this product during one of the five treatment periods in the crossover study design. | Other | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
Primary outcome
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
Time frame: Three Weeks per each of five arms
* surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation: * SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).
2 secondary outcomes
% Acid Resistance Score Per Each of Five Arms
Time frame: Three Weeks per each of five arms
Enamel Fluoride Uptake Per Each of Five Arms
Time frame: Three Weeks per each of five arms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24513113Lippert F, Martinez-Mier EA, Zero DT. An in situ caries study on the interplay between fluoride dose and concentration in milk. J Dent. 2014 Jul;42(7):883-90. doi: 10.1016/j.jdent.2014.01.010. Epub 2014 Feb 7.
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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.
Frank Lippert, PhD principal investigator
Indiana University
Domenick Zero, DDS, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 mg Sodium Fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk and 3 mg sodium fluoride in 100 ml milk in people with Caries, run by Frank Lippert at 1 site 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 9 inclusion and 6 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 23 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 1 site 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. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2014). 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?
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms (time frame: Three Weeks per each of five arms). 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 NCT01665911, 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 23 Feb 2015.