A study to assess the ability to detect dental plaque by a new device using fluorescence based technology.
| ISRCTN | ISRCTN84038664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84038664 |
| Secondary identifying numbers | Clinical protocol 2021111 |
- Submission date
- 30/06/2022
- Registration date
- 05/07/2022
- Last edited
- 11/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Dental plaque is a causative factor for oral diseases and thus its removal and control are an important aspect of oral health maintenance. Young and fresh plaque that has adhered to the enamel surface for a short time does not cause problems, but old and mature dental plaque (for example by a lack of oral hygiene) can cause plaque-associated diseases such as gingivitis. Therefore, it is clinically important to monitor the progression of plaque accumulation with respect to its age and its degree of coverage on dental surfaces.
Since dental plaque is hard to be observed by the naked eye, it is usually disclosed with a staining agent that allows visual identification in dental plaque assessment. More recently, a new technology has been developed and applied to optically assess dental plaque without a disclosing agent. Quantitative Light-Induced Fluorescence (QLF) is an optical method to detect porphyrin caused red-fluorescence occurring in plaque bacteria which are contributing or adhering to caries (including early white spot lesions), tartar, fluorosis and others. QLF is a light-based, non-invasive, non-destructive, and participant-compliant method without the need of using any disclosing agent.
The objective of this study is to evaluate a newly developed QLF- and AI- (Artificial Intelligence) based intra-oral camera, called “oral scanner” and compare it to a modified examiner-based index measuring plaque.
Who can participate?
Adult and adolescent (13+) participants, who meet inclusion criteria, having dental plaque and have one of the following endpoints: demineralized enamel/white spots lesions, remineralized caries at the fissures and accessory cups, caries, tartar and/or fluorosis will be enrolled in this study.
What does the study involve?
At visit one, an evaluation will be made for each of the available endpoints assessed by a trained dental professional, and the detection and visualization using the QLF-AI-based oral scanner. For the assessment of plaque, participants will be instructed to refrain from all oral hygiene procedures for approximately 24 hours prior to their appointment.
The examiner will assess the oral conditions. Then participants will be asked to use the oral scanner to scan their teeth on their own, once before the dental professional scans the participants' teeth. Additionally, participants’ teeth will be scanned/captured twice by the use of a professional 3D dental scanner “Primescan AC” from Dentsply Sirona a) with non-disclosed plaque b) with disclosed plaque.
What are the possible benefits and risks of participating?
Participation will help with the development of products that aim to improve oral health. There will be no notable risks involved with participating.
Where is the study run from?
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Klinik für Zahn-, Mund- und Kieferkrankheiten, Poliklinik für Kieferorthopädie
55131 Mainz (Germany)
When is the study starting and how long is it expected to run for?
August 2022 to September 2022
Who is funding the study?
Procter and Gamble Company (USA)
Who is the main contact?
Prof. Dr. Christina Erbe, PhD
erbe@uni-mainz.de
Contact information
Scientific
Augustusplatz 2
Mainz
55131
Germany
| Phone | +49-6131 173024 |
|---|---|
| erbe@uni-mainz.de |
Study information
| Study design | Non-randomized single-center supervised use observational pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participants information sheet. |
| Scientific title | A clinical evaluation of plaque detection by a newly developed QLF (Quantified Light-Induced Fluorescence) based technology |
| Study hypothesis | The objective of this study is to evaluate a newly developed QLF- and AI- (Artificial Intelligence) based intra-oral camera, called “oral scanner” and compare it to a modified examiner-based index measuring plaque. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Dental plaque and one of the following endpoints: - enamel decalcification/white spot lesions - remineralized caries at the fissures and accessory cusps - caries - tartar - fluorosis |
| Intervention | At the screening, a dental plaque assessment is performed by a dental professional followed by the exams of enamel decalcification/white spot lesions, remineralization of caries at the fissures and accessory cusps, caries, tartar and fluorosis. At the second visit, a full mouth scan with the oral scanner test device is performed first by the participant and second by the examiner. Next the examiner is assessing dental plaque on all teeth. After participants brush their teeth, the examiner performs the enamel decalcification index, white spots, remineralization of caries at the fissures and accessory cusps, caries, tartar and fluorosis. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | At a single time point: 1. Dental plaque (pre-brushing) measured by test device and examiner based dental plaque index. 2. Enamel decalcification/ white spots measured by Enamel Decalcification Index. 3. Oral Conditions (by tooth/surface presence of remineralization of caries at the fissures and accessory cusps, caries, tartar, fluorosis) measured by appropriate common indices. |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 24/05/2022 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Give written informed consent (if underage including her/his guardians) and given a signed copy of the Informed Consent form; 2. Be at least 13 years of age; 3. Have no fixed orthodontic appliance or attachments on both arches, Retainer in both arches are allowed; 4. Provide written informed consent prior to participation and be given a signed copy of the informed consent form; 5. Have plaque and at least one more of the following: demineralization/white spot lesions, remineralized caries at the fissures and accessory cusps, caries, tartar, fluorosis; 6. Possess a minimum of 24 natural and crowned/bridges evaluable teeth including 8 frontal teeth; 7. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study; 8. Agree not to participate in any other clinical study for the duration of this study; 9. Agree to delay any elective dentistry, including dental prophylaxis, until study completion; 10. Agree to return for the scheduled clinical visit and follow study procedures. |
| Participant exclusion criteria | 1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; 2. Active treatment for periodontitis; 3. Use of antibiotics two weeks prior to study initiation; 4. Any diseases or conditions that could be expected to interfere with the subject safely completing the study. 5. Presence of cardiac pacemaker; 6. Dental prophylaxis within 2 weeks prior to the screening visit. 7. Fixed orthodontic appliance e.g. Multibrackets apparatus or attachments on at least one arch |
| Recruitment start date | 20/07/2022 |
| Recruitment end date | 29/07/2022 |
Locations
Countries of recruitment
- Germany
Study participating centre
Mainz
55131
Germany
Sponsor information
Industry
8700 Mason Montgomery Road
Mason
45040
United States of America
| Phone | +1 (0)513 622 1000 |
|---|---|
| erb.j@pg.com | |
| Website | http://www.pg.com/en_US/ |
"ROR" |
https://ror.org/04dkns738 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Procter & Gamble, PandG, The Procter & Gamble Company, P&G
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol, statistical analysis plan, and other additional documents are not intended to become available online. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available because if the raw data is available but not analyzed appropriately by qualified experts in the area, it may lead to misinterpretation of the results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 11/11/2021 | 11/10/2024 | No | No |
Additional files
Editorial Notes
11/10/2024: The basic results have been uploaded as an additional file.
01/07/2022: Trial's existence confirmed by Universitätsmedizin der Johannes-Gutenberg-Universität Mainz.
