NCT02545660

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

June 9, 2022

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

September 2, 2015

Last Update Submit

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

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.

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.

Other: White Light Image

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.

QLF Image

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.

White light Image

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Norah Flannigan

    University of Liverpool

    PRINCIPAL INVESTIGATOR

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

Locations