Complication of Personal Oral HygieneNCT02545660
The Use of Quantitative Light Induced Fluorescence Digital as an Oral Hygiene Evaluation Tool in Orthodontics
A study testing QLF Image and White Light Image in people with Complication of Personal Oral Hygiene, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is because food easily accumulates around the braces and it is more difficult to clean when the braces are in place. The plaque accumulation can lead to demineralisation (white spots) developing on the teeth. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Personal Oral Hygiene
- What is being tested?
- QLF Image and White Light Image
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2015to 30 Dec 2016
- Phase
- Interventional
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All participants will consent.
- All participants will be in good health.
- At least 11 years of age.
- Patients with poor level of oral hygiene undergoing pre-treatment visits with the hygienist or a dentist.
Who cannot join
- Patients with significant disabilities that may affect manual dexterity and oral hygiene practice.
- Patients who have had antibiotics in the last two months.
- Patients with full coronal coverage restorations.
- Patients with visually cavitated lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of QLF-D (Quantitative Light-induced Fluorescence-DigitalTM) as an Oral Hygiene Evaluation Tool to Assess Plaque Accumulation and Enamel Demineralisation in Orthodontics
During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is because food easily accumulates around the braces and it is more difficult to clean when the braces are in place. The plaque accumulation can lead to demineralisation (white spots) developing on the teeth. This is the start of decay and can lead to permanent marks and fillings being required.Prior to the start of orthodontic treatment adequate oral hygiene is necessary.
During orthodontic treatment, it is important that patients have an excellent level of oral hygiene to prevent plaque accumulating and demineralisation occurring. However, adequate tooth brushing can be difficult to perform as the bacterial plaque is not easily visible. Thus patients may not be able to see which areas need better tooth brushing.
QLFD(Quantitative Light Induced Fluorescence Digital) is a noninvasive method that uses fluorescent light to illuminate the oral bacteria in plaque that are responsible for demineralisation. The purpose of this study is to use the QLFD camera to assess its ability to measure plaque accumulation and demineralisation before the start of orthodontic treatment. The study will also assess the QLFD camera as a tool to improve oral hygiene.
Read the detailed description
Plaque is a contributing factor for the development of dental diseases including tooth decay and gum disease. Thus, an excellent standard of oral hygiene is required to ensure all plaque is removed from the teeth to reduce the risk of developing these diseases.
Plaque accumulation starts and is greatest at plaque stagnation sites, which tend to be at the gum margins. In orthodontic treatment, the brackets and archwires are significant plaque stagnation sites.Conventional tooth brushing is also more difficult compounding the increased plaque accumulation and retention.
It is very important that patients learn to recognize the presence of plaque to ensure optimal levels of oral hygiene are achieved. Frequently patients have difficulty localizing the deposits to enable optimal levels of oral hygiene.
Demineralisation occurs due to bacterial fermentation of dietary sugars, which produces acids. This leads to white marks developing on the tooth surfaces, which is the first stage of dental caries. The risk of demineralisation is increased during orthodontic treatment, as there tends to be greater plaque accumulation. Previous studies have reported prevalence rates of demineralisation during orthodontic treatment to be as high as 96%. The most visible front surfaces of the teeth are often the most severely affected which can have a detrimental impact on their appearance.
Early demineralisation can be reversible if plaque control is improved, however progresses cavities may develop which require restoration. The main form of management of demineralisation is prevention. This is mainly by having an excellent level of oral hygiene and having a diet with a limited number of sugar intakes.
During orthodontics, patients frequently find it difficult to detect the plaque around the braces, thus oral hygiene is often not adequate. This leads to greater plaque accumulation and an increased risk of developing demineralisation.
The QLFD Biluminator is a noninvasive novel device, based on previous QLF technology. In vitro and in vivo studies of the former QLF device demonstrated it to be appropriate for identifying demineralisation and longitudinal monitoring of mineral changes during orthodontics. The advantage of the new QLFD device is that it takes a white light image in addition to a QLF image. Having two images, taken nearly simultaneously, allows comparisons to be made and ensures consistency with regards to magnification and angulation. From these images, plaque accumulation and demineralisation can be measured. In addition, demineralisation can be detected on QLF images before it is evident on white light images, which is of great benefit to clinicians in detecting at risk patients.
This study aims to assess plaque accumulation and demineralisation using the new QLFD device before the start of orthodontic treatment. It will also assess its use as an oral hygiene evaluation tool to improve patients tooth brushing who have inadequate oral hygiene to start orthodontic treatment. White light and QLF images will be taken with the QLFD device and patients will be given focused oral hygiene advice based on these images.
- Conditions
- Complication of Personal Oral Hygiene
- Being tested
- QLF Image, White Light Image
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF ImageOther
At each of the three visits tooth brushing advice will be given. The participants in the intervention group will be shown the QLFD images or white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction.
White Light ImageOther
At each of the three visits tooth brushing advice will be given. The participants in the white light image group will be shown white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction.
| Study group | Role | What they receive |
|---|---|---|
| QLF Image | Experimental | At each of the three visits tooth brushing advice will be given. The participants in the QLF group will be shown the QLFD images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. Receives: Other: QLF Image |
| White light Image | Experimental | At each of the three visits tooth brushing advice will be given. The participants in the white light image group will be shown the White light images.Standardized oral hygiene reinforcement shall be given based on the White light images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. Receives: Other: White Light Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find difference in plaque accumulation (ΔR30)between the White light group and QLF groups.
The difference in plaque accumulation (ΔR30) between the White light group and QLF groups from visit 1 to visit 3 will be measured. QLFD camera will take QLF(blue light) and WL (white light) photographs. Either white light image or QLF image (based on which group patient is randomized to) will be used to provide visual feedback on plaque accumulation present and focused tooth brushing advice will be provided at three appointments.
Measured: 6 Months
Secondary outcomes (1)
To find difference in demineralisation (ΔF) between the White light group and QLF groups from visit 1 to visit 3.
The difference in demineralisation (ΔF) between the White light group and QLF groups from visit 1 to visit 3 will be measured. The QLFD camera will take QLF(blue light) and WL (white light) photographs. Either white light image or QLF image (based on which group patient is randomized to will be used to provide visual feedback on the demineralisation present and focused tooth brushing advice will be provided at three appointments.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start1 Dec 2015
- Primary completion4 Oct 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Personal Oral HygieneStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Norah Flannigan, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545660
- Sponsor's protocol ID
- 4984
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2015
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of QLF-D (Quantitative Light-induced Fluorescence-DigitalTM) as an Oral Hygiene Evaluation Tool to Assess Plaque Accumulation and Enamel Demineralisation in Orthodontics
- ClinicalTrials.gov ID
- NCT02545660
- Acronym / sponsor ID
- 4984
- Conditions
- Complication of Personal Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- University of Liverpool
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 10 Sep 2015 (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.
During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is because food easily accumulates around the braces and it is more difficult to clean when the braces are in place. The plaque accumulation can lead to demineralisation (white spots) developing on the teeth. This is the start of decay and can lead to permanent marks and fillings being required.Prior to the start of orthodontic treatment adequate oral hygiene is necessary.
During orthodontic treatment, it is important that patients have an excellent level of oral hygiene to prevent plaque accumulating and demineralisation occurring. However, adequate tooth brushing can be difficult to perform as the bacterial plaque is not easily visible. Thus patients may not be able to see which areas need better tooth brushing.
QLFD(Quantitative Light Induced Fluorescence Digital) is a noninvasive method that uses fluorescent light to illuminate the oral bacteria in plaque that are responsible for demineralisation. The purpose of this study is to use the QLFD camera to assess its ability to measure plaque accumulation and demineralisation before the start of orthodontic treatment. The study will also assess the QLFD camera as a tool to improve oral hygiene.
Detailed description
Plaque is a contributing factor for the development of dental diseases including tooth decay and gum disease. Thus, an excellent standard of oral hygiene is required to ensure all plaque is removed from the teeth to reduce the risk of developing these diseases.
Plaque accumulation starts and is greatest at plaque stagnation sites, which tend to be at the gum margins. In orthodontic treatment, the brackets and archwires are significant plaque stagnation sites.Conventional tooth brushing is also more difficult compounding the increased plaque accumulation and retention.
It is very important that patients learn to recognize the presence of plaque to ensure optimal levels of oral hygiene are achieved. Frequently patients have difficulty localizing the deposits to enable optimal levels of oral hygiene.
Demineralisation occurs due to bacterial fermentation of dietary sugars, which produces acids. This leads to white marks developing on the tooth surfaces, which is the first stage of dental caries. The risk of demineralisation is increased during orthodontic treatment, as there tends to be greater plaque accumulation. Previous studies have reported prevalence rates of demineralisation during orthodontic treatment to be as high as 96%. The most visible front surfaces of the teeth are often the most severely affected which can have a detrimental impact on their appearance.
Early demineralisation can be reversible if plaque control is improved, however progresses cavities may develop which require restoration. The main form of management of demineralisation is prevention. This is mainly by having an excellent level of oral hygiene and having a diet with a limited number of sugar intakes.
During orthodontics, patients frequently find it difficult to detect the plaque around the braces, thus oral hygiene is often not adequate. This leads to greater plaque accumulation and an increased risk of developing demineralisation.
The QLFD Biluminator is a noninvasive novel device, based on previous QLF technology. In vitro and in vivo studies of the former QLF device demonstrated it to be appropriate for identifying demineralisation and longitudinal monitoring of mineral changes during orthodontics. The advantage of the new QLFD device is that it takes a white light image in addition to a QLF image. Having two images, taken nearly simultaneously, allows comparisons to be made and ensures consistency with regards to magnification and angulation. From these images, plaque accumulation and demineralisation can be measured. In addition, demineralisation can be detected on QLF images before it is evident on white light images, which is of great benefit to clinicians in detecting at risk patients.
This study aims to assess plaque accumulation and demineralisation using the new QLFD device before the start of orthodontic treatment. It will also assess its use as an oral hygiene evaluation tool to improve patients tooth brushing who have inadequate oral hygiene to start orthodontic treatment. White light and QLF images will be taken with the QLFD device and patients will be given focused oral hygiene advice based on these images.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLF Image | Experimental | Other: QLF ImageAt each of the three visits tooth brushing advice will be given. The participants in the QLF group will be shown the QLFD images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. |
| White light Image | Experimental | Other: White Light ImageAt each of the three visits tooth brushing advice will be given. The participants in the white light image group will be shown the White light images.Standardized oral hygiene reinforcement shall be given based on the White light images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All participants will consent.
- All participants will be in good health.
- At least 11 years of age.
- Patients with poor level of oral hygiene undergoing pre-treatment visits with the hygienist or a dentist.
Key exclusion criteria (4 listed)
- Patients with significant disabilities that may affect manual dexterity and oral hygiene practice.
- Patients who have had antibiotics in the last two months.
- Patients with full coronal coverage restorations.
- Patients with visually cavitated lesions.
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 |
|---|---|---|
| QLF ImageAt each of the three visits tooth brushing advice will be given. The participants in the intervention group will be shown the QLFD images or white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. | Other | QLF Image |
| White Light ImageAt each of the three visits tooth brushing advice will be given. The participants in the white light image group will be shown white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction. | Other | White light Image |
Primary outcome
To find difference in plaque accumulation (ΔR30)between the White light group and QLF groups.
Time frame: 6 Months
The difference in plaque accumulation (ΔR30) between the White light group and QLF groups from visit 1 to visit 3 will be measured. QLFD camera will take QLF(blue light) and WL (white light) photographs. Either white light image or QLF image (based on which group patient is randomized to) will be used to provide visual feedback on plaque accumulation present and focused tooth brushing advice will be provided at three appointments.
1 secondary outcome
To find difference in demineralisation (ΔF) between the White light group and QLF groups from visit 1 to visit 3.
Time frame: 6 Months
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 9 Jun 2022.
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.
Norah Flannigan principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLF Image and White Light Image in people with Complication of Personal Oral Hygiene, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 9 Jun 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 Kingdom. 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?
To find difference in plaque accumulation (ΔR30)between the White light group and QLF groups. (time frame: 6 Months). 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 9 Jun 2022.