Dental CariesWSLsNCT04186065
The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances
An observational study of Dental Caries, run by Hiroko Nagaoka at 1 site in United States.
Trial summary
This study investigates how often cavities develop on the permanent teeth of patients with braces (orthodontic treatment). The hypothesis is that there is no difference in the number of cavities on the permanent teeth of patients with braces compared to similar patients without braces. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Oct 2019
- Phase
- Observational
- 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants have to be 10 years older who are treatment planned for orthodontic treatment with fixed appliances in the Graduate or Faculty Orthodontic Clinic at University of Kentucky. Based upon the racial distribution of patients currently receiving treatment in the Graduate and Faculty Orthodontic Clinics, investigators expect that study population to be predominantly Caucasian, with minority representation from the African-American and Hispanic communities. The sample composition is expected to be equally weighted with respect to gender.
Who may be able to join
- Patients who agreed to participate in this study
- Patients who receive orthodontic treatment with fixed appliances at University of Kentucky College of Dentistry
- Patients who have either metal or ceramic brackets for the treatment
Who cannot join
- Patients on a daily supplemental fluoride regimen
- Patients who has difficulty in their daily toothbrushing due to their physical disability
- Patients with lingual fixed appliances
- Patients who are pregnant
- Patients with restorations placed on the facial/buccal surface of the tooth from premolar to premolar for both arches.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky College of Dentistry
Lexington, Kentucky, 40536-0297
About this study
Official title: Cross-Sectional Study: The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances
This study investigates how often cavities develop on the permanent teeth of patients with braces (orthodontic treatment). The hypothesis is that there is no difference in the number of cavities on the permanent teeth of patients with braces compared to similar patients without braces.
Read the detailed description
The purpose of this cross-sectional study is to determine the prevalence of early carious lesions (white spot lesions, or WSLs) for patients who are receiving orthodontic treatment compared to patients who are not receiving orthodontic treatment.
Subjects will be recruited from the University of Kentucky Orthodontic Clinic patient pool. Orthodontic care at the University of Kentucky College of Dentistry (UKCOD) is provided by orthodontic faculty, as well as students enrolled in the graduate orthodontic program at the UKCOD. Subjects will be invited to participate in this study after receiving an initial treatment plan with fixed appliances for at least one arch.
- Conditions
- Dental Caries
- Keywords
- white spot, lesions, tooth
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
The formation of early caries lesion on teeth (white spot lesions)
Teeth of study subjects will be evaluated for the formation of white spot lesions based on their intraoral photographs taken at their participation for the study.
Measured: One-time assessment at participant visit (approximately 30 minutes).
The dental plaque deposit on teeth.
Teeth of study subjects will be stained with the plaque disclosing agent. After rinsing off the disclosing agent, intraoral photographs are taken for later analysis of dental plaque accumulation.
Measured: One-time assessment at participant visit (approximately 30 minutes).
Subjects' of attitude toward the oral hygiene practice.
Participants will be asked to take an electronic questionnaire (through REDCap) consisting of 13 items that assess their dental hygiene practice and attitude toward orthodontic treatment. Individual question responses range from 0-7 (cumulative range of 0-91) with higher scores indicating more positive attitudes.
Measured: One-time assessment at participant visit (approximately 30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Mar 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroko Nagaoka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hiroko Nagaoka, University of Kentucky
- Investigators
- Hiroko Nagaoka, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186065
- Sponsor's protocol ID
- 47148
- Acronym
- WSLs
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2019
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study: The Prevalence of White Spot Lesions During Orthodontic Treatment With Fixed Appliances
- ClinicalTrials.gov ID
- NCT04186065
- Acronym / sponsor ID
- WSLs / 47148
- Conditions
- Dental Caries
- Keywords
- white spot, lesions, tooth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hiroko NagaokaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 4 Dec 2019 (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.
This study investigates how often cavities develop on the permanent teeth of patients with braces (orthodontic treatment). The hypothesis is that there is no difference in the number of cavities on the permanent teeth of patients with braces compared to similar patients without braces.
Detailed description
The purpose of this cross-sectional study is to determine the prevalence of early carious lesions (white spot lesions, or WSLs) for patients who are receiving orthodontic treatment compared to patients who are not receiving orthodontic treatment.
Subjects will be recruited from the University of Kentucky Orthodontic Clinic patient pool. Orthodontic care at the University of Kentucky College of Dentistry (UKCOD) is provided by orthodontic faculty, as well as students enrolled in the graduate orthodontic program at the UKCOD. Subjects will be invited to participate in this study after receiving an initial treatment plan with fixed appliances for at least one arch.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants have to be 10 years older who are treatment planned for orthodontic treatment with fixed appliances in the Graduate or Faculty Orthodontic Clinic at University of Kentucky. Based upon the racial distribution of patients currently receiving treatment in the Graduate and Faculty Orthodontic Clinics, investigators expect that study population to be predominantly Caucasian, with minority representation from the African-American and Hispanic communities. The sample composition is expected to be equally weighted with respect to gender.
Key inclusion criteria (3 listed)
- Patients who agreed to participate in this study
- Patients who receive orthodontic treatment with fixed appliances at University of Kentucky College of Dentistry
- Patients who have either metal or ceramic brackets for the treatment
Key exclusion criteria (5 listed)
- Patients on a daily supplemental fluoride regimen
- Patients who has difficulty in their daily toothbrushing due to their physical disability
- Patients with lingual fixed appliances
- Patients who are pregnant
- Patients with restorations placed on the facial/buccal surface of the tooth from premolar to premolar for both arches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The formation of early caries lesion on teeth (white spot lesions)
Time frame: One-time assessment at participant visit (approximately 30 minutes).
Teeth of study subjects will be evaluated for the formation of white spot lesions based on their intraoral photographs taken at their participation for the study.
The dental plaque deposit on teeth.
Time frame: One-time assessment at participant visit (approximately 30 minutes).
Teeth of study subjects will be stained with the plaque disclosing agent. After rinsing off the disclosing agent, intraoral photographs are taken for later analysis of dental plaque accumulation.
Subjects' of attitude toward the oral hygiene practice.
Time frame: One-time assessment at participant visit (approximately 30 minutes).
Participants will be asked to take an electronic questionnaire (through REDCap) consisting of 13 items that assess their dental hygiene practice and attitude toward orthodontic treatment. Individual question responses range from 0-7 (cumulative range of 0-91) with higher scores indicating more positive attitudes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Hiroko Nagaoka principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Hiroko Nagaoka 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 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The formation of early caries lesion on teeth (white spot lesions) (time frame: One-time assessment at participant visit (approximately 30 minutes).). 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 24 Jun 2020.