Dental CariesNobioNCT04059250
Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite
A study testing Nobio composite and traditional composite in people with Dental Caries and Denture, Partial, Removable, run by University of California, San Francisco at 1 site in United States.
Trial summary
Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Denture, Partial, Removable
- What is being tested?
- Nobio composite and traditional composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 10 Mar 2020
- 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
- aged between 18 and 80 years,
- have at least six natural teeth remaining and have a recent history of dental caries
- wearing lower partial denture (with replaced teeth on both sides of the mouth)
- willing to wear their denture during the night
- are in good health, of either gender
- are in good current oral health with no active caries or periodontal disease (but with a history of caries)
Show all 14Show fewer
- have an understanding of the study
- have saliva flow within the normal range (stimulated saliva flow rate of greater than 0.7 ml/minute)
- no antibiotics for the last three months
- willing to comply with all study procedures and protocols,
- residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
- able to give written consent themselves
- must be able to read and understand English
- willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
Who cannot join
- subjects who have less than 6 natural teeth remaining
- subjects who have used a 5,000 ppm fluoride toothpaste in the last 6 months
- subjects who have used Chlorhexidine or any other antimicrobials (cetylpyridinium etc.) in the last 6 months
- show evidence of extremely poor oral hygiene
- subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
- taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia)
Show all 9Show fewer
- other conditions that may decrease the likelihood of adhering to study protocol
- in-office fluoride treatment within the last three months
- subjects who will leave the area and are unable to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF School of Dentistry, Preventive and Restorative Dental Sciences
San Francisco, California, 94143
About this study
Official title: Nobio In Situ Clinical Study - Pilot Study
Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings.
The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.
Read the detailed description
As a major issue in dentistry, it has been stated that two-thirds of all restorative dentistry involves the replacement of failed restorations. Secondary caries indicates a lesion developing at the margins of an existing restoration and is the major reason for replacement of amalgam and composite resin restorations in operative dentistry.
In research the use of experimental intra-oral caries models dealing with caries prevention has increased. The most realistic experimental model is the in vivo model that uses living teeth, followed by the in situ model using specimens with natural surfaces held in the mouth during the experimental period. In situ models have the potential to study both fundamental aspects of the caries process as well as more applied research problems in caries prevention in human subjects without actually causing caries in the natural dentition.
To simulate a failed interface between a tooth and a restoration, a gap can be formed between an enamel slab and the restoration prior to a cariogenic challenge. The "gap-model" will be inserted for instance into the denture flanges, and the cariogenic challenge occurs inside the mouth during the wear period..
Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. The ongoing caries activity due to bacteria around the filling may be interrupted by quaternary ammonium silica dioxide (QASi) particles incorporated in the test composite at 1.2% (by weight). These particles are members of the Nobio Antimicrobial Particle (NAP) family (Nobio, Israel). QASi are synthesized to form a high concentration of antimicrobial groups that are covalently-bound onto a carrier core, such as silica. The resulting micro or nano-sized QASi particles are mixed with other fillers of the dental composite material, during manufacturing. Following in situ placement and light-initiated polymerization, QASi particles are permanently retained in the final dental restoration. Laboratory studies have shown that the quaternary ammonium silica particles are potent antibacterial agents, do not leach out in contrast to other antimicrobials or caries preventive active substances, inhibit the breakdown of the composite, and maintain antibacterial activity over time.
The study is an in situ study. Subjects, wearing lower partial dentures with acrylic flanges on both sides of the mouth will be recruited. On each side of the denture an enamel slab will be placed next to a composite, separated by a tiny gap. On one side of the denture the composite will be Nobio's antibacterial composite, on the other side a regular composite (a Nobio composite w/o particles or another commercial composite will serve as control material. Enamel slab and composite will be recessed into the flange, allowing microbial plaque to accumulate on top of it and especially in the gap.
After wearing the dentures for four weeks with the slabs, decalcification - ΔZ mineral loss - in the enamel slabs adjacent to the gap will be determined by cross-section microhardness testing in the laboratory. Average ΔZ mineral loss will be calculated for the Nobio group and the control group, and difference will be tested for statistical significance.
- Conditions
- Dental Caries, Denture, Partial, Removable
- Being tested
- Nobio composite, traditional composite
- Keywords
- composite bactericidal, caries prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nobio compositeDevice
Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
traditional compositeDevice
traditional composite which has no bactericidal activities
| Study group | Role | What they receive |
|---|---|---|
| Nobio flange | Experimental | On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite. Receives: Device: Nobio composite |
| Traditional composite flange | Placebo comparator | On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite. Receives: Device: traditional composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral Loss ΔZ
The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model.
The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm * vol % mineral) is calculated using Simpson's integration rule.
Measured: mineral loss ΔZ is determined after the 4 week wearing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start28 May 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
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 (15)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In-situ testing using a gap model inside the two flanges of a removable partial denture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Nobio Ltd.
- Responsible party
- Sponsor
- Investigators
- Peter Rechmann, Principal investigator, UCSF - School of Dentistry - Preventive and Restorative Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059250
- Sponsor's protocol ID
- P0535966
- Acronym
- Nobio
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2019
- Last updated
- 12 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Clasen AB, Ogaard B. Experimental intra-oral caries models in fluoride research. Acta Odontol Scand. 1999 Dec;57(6):334-41. doi: 10.1080/000163599428580.
PubMed 10777137Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.
PubMed 8615944Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.
PubMed 12532056Maupome G, Sheiham A. Criteria for restoration replacement and restoration life-span estimates in an educational environment. J Oral Rehabil. 1998 Dec;25(12):896-901. doi: 10.1046/j.1365-2842.1998.00328.x.
PubMed 9888223Kidd EA. Diagnosis of secondary caries. J Dent Educ. 2001 Oct;65(10):997-1000.
PubMed 11700003Hals E, Nernaes A. Histopathology of in vitro caries developing around silver amalgam fillings. Caries Res. 1971;5(1):58-77. doi: 10.1159/000259733. No abstract available.
PubMed 5277150Kuper NK, Montagner AF, van de Sande FH, Bronkhorst EM, Opdam NJ, Huysmans MC. Secondary Caries Development in in situ Gaps next to Composite and Amalgam. Caries Res. 2015;49(5):557-63. doi: 10.1159/000438728. Epub 2015 Sep 26.
PubMed 26407050Hollanders ACC, Kuper NK, Maske TT, Huysmans MDNJM. Secondary Caries in situ Models: A Systematic Review. Caries Res. 2018;52(6):454-462. doi: 10.1159/000487200. Epub 2018 Apr 5.
PubMed 29621757Benelli EM, Serra MC, Rodrigues AL Jr, Cury JA. In situ anticariogenic potential of glass ionomer cement. Caries Res. 1993;27(4):280-4. doi: 10.1159/000261551.
PubMed 8402802Dijkman GE, Arends J. Secondary caries in situ around fluoride-releasing light-curing composites: a quantitative model investigation on four materials with a fluoride content between 0 and 26 vol%. Caries Res. 1992;26(5):351-7. doi: 10.1159/000261467.
PubMed 1468099Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
PubMed 16564083Beyth N, Houri-Haddad Y, Baraness-Hadar L, Yudovin-Farber I, Domb AJ, Weiss EI. Surface antimicrobial activity and biocompatibility of incorporated polyethylenimine nanoparticles. Biomaterials. 2008 Nov;29(31):4157-63. doi: 10.1016/j.biomaterials.2008.07.003. Epub 2008 Aug 3.
PubMed 18678404Beyth N, Yudovin-Fearber I, Domb AJ, Weiss EI. Long-term antibacterial surface properties of composite resin incorporating polyethyleneimine nanoparticles. Quintessence Int. 2010 Nov-Dec;41(10):827-35.
PubMed 20927419Chatzistavrou X, Velamakanni S, DiRenzo K, Lefkelidou A, Fenno JC, Kasuga T, Boccaccini AR, Papagerakis P. Designing dental composites with bioactive and bactericidal properties. Mater Sci Eng C Mater Biol Appl. 2015;52:267-72. doi: 10.1016/j.msec.2015.03.062. Epub 2015 Mar 28.
PubMed 25953567Rechmann P, Le CQ, Chaffee BW, Rechmann BMT. Demineralization prevention with a new antibacterial restorative composite containing QASi nanoparticles: an in situ study. Clin Oral Investig. 2021 Sep;25(9):5293-5305. doi: 10.1007/s00784-021-03837-4. Epub 2021 Feb 19.
PubMed 33608748
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nobio In Situ Clinical Study - Pilot Study
- ClinicalTrials.gov ID
- NCT04059250
- Acronym / sponsor ID
- Nobio / P0535966
- Conditions
- Dental Caries, Denture, Partial, Removable
- Keywords
- composite bactericidal, caries prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Nobio Ltd.
- Study start
- 28 May 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Posted 12 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings.
The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.
Detailed description
As a major issue in dentistry, it has been stated that two-thirds of all restorative dentistry involves the replacement of failed restorations. Secondary caries indicates a lesion developing at the margins of an existing restoration and is the major reason for replacement of amalgam and composite resin restorations in operative dentistry.
In research the use of experimental intra-oral caries models dealing with caries prevention has increased. The most realistic experimental model is the in vivo model that uses living teeth, followed by the in situ model using specimens with natural surfaces held in the mouth during the experimental period. In situ models have the potential to study both fundamental aspects of the caries process as well as more applied research problems in caries prevention in human subjects without actually causing caries in the natural dentition.
To simulate a failed interface between a tooth and a restoration, a gap can be formed between an enamel slab and the restoration prior to a cariogenic challenge. The "gap-model" will be inserted for instance into the denture flanges, and the cariogenic challenge occurs inside the mouth during the wear period..
Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. The ongoing caries activity due to bacteria around the filling may be interrupted by quaternary ammonium silica dioxide (QASi) particles incorporated in the test composite at 1.2% (by weight). These particles are members of the Nobio Antimicrobial Particle (NAP) family (Nobio, Israel). QASi are synthesized to form a high concentration of antimicrobial groups that are covalently-bound onto a carrier core, such as silica. The resulting micro or nano-sized QASi particles are mixed with other fillers of the dental composite material, during manufacturing. Following in situ placement and light-initiated polymerization, QASi particles are permanently retained in the final dental restoration. Laboratory studies have shown that the quaternary ammonium silica particles are potent antibacterial agents, do not leach out in contrast to other antimicrobials or caries preventive active substances, inhibit the breakdown of the composite, and maintain antibacterial activity over time.
The study is an in situ study. Subjects, wearing lower partial dentures with acrylic flanges on both sides of the mouth will be recruited. On each side of the denture an enamel slab will be placed next to a composite, separated by a tiny gap. On one side of the denture the composite will be Nobio's antibacterial composite, on the other side a regular composite (a Nobio composite w/o particles or another commercial composite will serve as control material. Enamel slab and composite will be recessed into the flange, allowing microbial plaque to accumulate on top of it and especially in the gap.
After wearing the dentures for four weeks with the slabs, decalcification - ΔZ mineral loss - in the enamel slabs adjacent to the gap will be determined by cross-section microhardness testing in the laboratory. Average ΔZ mineral loss will be calculated for the Nobio group and the control group, and difference will be tested for statistical significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In-situ testing using a gap model inside the two flanges of a removable partial denture
| Arm | Type | Receives |
|---|---|---|
| Nobio flange | Experimental | Device: Nobio compositeOn the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite. |
| Traditional composite flange | Placebo comparator | Device: traditional compositeOn the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- aged between 18 and 80 years,
- have at least six natural teeth remaining and have a recent history of dental caries
- wearing lower partial denture (with replaced teeth on both sides of the mouth)
- willing to wear their denture during the night
- are in good health, of either gender
Key exclusion criteria (9 listed)
- subjects who have less than 6 natural teeth remaining
- subjects who have used a 5,000 ppm fluoride toothpaste in the last 6 months
- subjects who have used Chlorhexidine or any other antimicrobials (cetylpyridinium etc.) in the last 6 months
- show evidence of extremely poor oral hygiene
- subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
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 |
|---|---|---|
| Nobio compositeNobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers | Device | Nobio flange |
| traditional compositetraditional composite which has no bactericidal activities | Device | Traditional composite flange |
Primary outcome
Mineral Loss ΔZ
Time frame: mineral loss ΔZ is determined after the 4 week wearing period
The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model. The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm * vol % mineral) is calculated using Simpson's integration rule.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10777137Clasen AB, Ogaard B. Experimental intra-oral caries models in fluoride research. Acta Odontol Scand. 1999 Dec;57(6):334-41. doi: 10.1080/000163599428580.
- Background: PubMed 8615944Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.
- Background: PubMed 12532056Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.
- Background: PubMed 9888223Maupome G, Sheiham A. Criteria for restoration replacement and restoration life-span estimates in an educational environment. J Oral Rehabil. 1998 Dec;25(12):896-901. doi: 10.1046/j.1365-2842.1998.00328.x.
- Background: PubMed 11700003Kidd EA. Diagnosis of secondary caries. J Dent Educ. 2001 Oct;65(10):997-1000.
- Background: PubMed 5277150Hals E, Nernaes A. Histopathology of in vitro caries developing around silver amalgam fillings. Caries Res. 1971;5(1):58-77. doi: 10.1159/000259733. No abstract available.
- Background: PubMed 26407050Kuper NK, Montagner AF, van de Sande FH, Bronkhorst EM, Opdam NJ, Huysmans MC. Secondary Caries Development in in situ Gaps next to Composite and Amalgam. Caries Res. 2015;49(5):557-63. doi: 10.1159/000438728. Epub 2015 Sep 26.
- Background: PubMed 29621757Hollanders ACC, Kuper NK, Maske TT, Huysmans MDNJM. Secondary Caries in situ Models: A Systematic Review. Caries Res. 2018;52(6):454-462. doi: 10.1159/000487200. Epub 2018 Apr 5.
- Background: PubMed 8402802Benelli EM, Serra MC, Rodrigues AL Jr, Cury JA. In situ anticariogenic potential of glass ionomer cement. Caries Res. 1993;27(4):280-4. doi: 10.1159/000261551.
- Background: PubMed 1468099Dijkman GE, Arends J. Secondary caries in situ around fluoride-releasing light-curing composites: a quantitative model investigation on four materials with a fluoride content between 0 and 26 vol%. Caries Res. 1992;26(5):351-7. doi: 10.1159/000261467.
- Background: PubMed 16564083Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
- Background: PubMed 18678404Beyth N, Houri-Haddad Y, Baraness-Hadar L, Yudovin-Farber I, Domb AJ, Weiss EI. Surface antimicrobial activity and biocompatibility of incorporated polyethylenimine nanoparticles. Biomaterials. 2008 Nov;29(31):4157-63. doi: 10.1016/j.biomaterials.2008.07.003. Epub 2008 Aug 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rechmann principal investigator
UCSF - School of Dentistry - Preventive and Restorative Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nobio composite and traditional composite in people with Dental Caries and Denture, Partial, Removable, run by University of California, San Francisco 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 14 inclusion and 9 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 12 Mar 2021. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2021). 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?
Mineral Loss ΔZ (time frame: mineral loss ΔZ is determined after the 4 week wearing period). 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 NCT04059250, which also lists 15 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 12 Mar 2021.