The Use of Quantitative Light Induced Fluorescence Digital as an Oral Hygiene Evaluation Tool in Orthodontics
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
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedJune 9, 2022
September 1, 2015
10 months
September 2, 2015
June 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
6 Months
Study Arms (2)
QLF Image
EXPERIMENTALAt 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
EXPERIMENTALAt 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Norah Flannigan
Liverpool, Merseyside, L3 5PS, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Norah Flannigan
University of Liverpool
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 10, 2015
Study Start
December 1, 2015
Primary Completion
October 4, 2016
Study Completion
December 30, 2016
Last Updated
June 9, 2022
Record last verified: 2015-09