GingivitisNCT02178046
Non-Invasive Oral Biofilm Characterization
An observational study of Gingivitis, run by University of California, Irvine at 1 site in United States.
Trial summary
There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- optical measurements
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2014to 12 Aug 2019
- How long will I take part?
- 1 Month
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study population will be selected from UCI Medical Center a referral base for dentists in the greater Orange County area for diagnosis of patients with suspected intra-oral lesions. The UCI student dental health clinic caters to UCI students, staff and faculty.
Who may be able to join
- Adult male or female 18-25 years of age
- Volunteers with gingivitis but no periodontitis
Who cannot join
- Subjects who must receive dental treatment during the study dates.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
- Individuals who have taken antibiotics in the previous 3 months
- Individuals who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth
Read the detailed description
The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
- Conditions
- Gingivitis
- Being tested
- optical measurements
- Keywords
- Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical measurementsDevice
Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis | optical measurements Receives: Device: optical measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gingival perfusion
optical measurements
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start23 May 2014
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Petra Wilder-Smith, DDS. PhD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178046
- Sponsor's protocol ID
- 20141167
- Status last verified
- Oct 2022
- First submitted
- 26 Jun 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Oral Biofilm Characterization
- ClinicalTrials.gov ID
- NCT02178046
- Acronym / sponsor ID
- 20141167
- Conditions
- Gingivitis
- Keywords
- Gingivitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- 23 May 2014 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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.
There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth
Detailed description
The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gingivitis | – | Device: optical measurementsoptical measurements |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study population will be selected from UCI Medical Center a referral base for dentists in the greater Orange County area for diagnosis of patients with suspected intra-oral lesions. The UCI student dental health clinic caters to UCI students, staff and faculty.
Key inclusion criteria (2 listed)
- Adult male or female 18-25 years of age
- Volunteers with gingivitis but no periodontitis
Key exclusion criteria (4 listed)
- Subjects who must receive dental treatment during the study dates.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
- Individuals who have taken antibiotics in the previous 3 months
- Individuals who are pregnant or nursing
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 |
|---|---|---|
| optical measurementsLaser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy | Device | Gingivitis |
Primary outcome
Changes in gingival perfusion
Time frame: up to 6 weeks
optical measurements
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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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.
Petra Wilder-Smith, DDS. PhD principal investigator
Beckman Laser Institute, UCI
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 Gingivitis, run by University of California, Irvine 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in gingival perfusion (time frame: up to 6 weeks). 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 1 Nov 2022.