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Trial registered on ANZCTR
Registration number
ACTRN12623000463673
Ethics application status
Approved
Date submitted
3/04/2023
Date registered
5/05/2023
Date last updated
21/04/2024
Date data sharing statement initially provided
5/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Early detection of reversible gum disease using a novel ultrasound device.
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Scientific title
A study to validate use of a novel ultrasound device in early detection of gingivitis.
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Secondary ID [1]
309348
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Nil known
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Universal Trial Number (UTN)
U1111-1290-7155
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gingivitis
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Condition category
Condition code
Oral and Gastrointestinal
326486
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The participants will have to cease brushing 4 teeth of interest and using oral rinses for 21 days. They will receive professional cleaning twice. The participants will undergo gum health examination, which involves the following:
1. Ultrasound measurement of gums (Periomedic device)
2. An assessment of gum redness and swelling (Gingival Index)
3. An assessment of plaque present on the study teeth (Plaque index)
4. The gap between gum and tooth (if any) (Periodontal Probing Depth)
5. Assessment of gum bleeding (if any) (Gingival sulcus bleeding index)
6. Photograph of teeth to determine color of gums
Gum health examination will take place once every week, a total of 8 times. Approximately 30 minutes will be required to complete the examination. The examination will be conducted by a registered dentist.
Professional cleaning will be done immediately after gum health examination. Cleaning will be done twice during the entire study period, once before start of the study and next after 21 days.
Adherence to intervention will be monitored in the dental undergraduate class which all the volunteers attend by recording responses in the attendance sheet.
Patients will feel slight vibration as the novel ultrasound device comes in contact with their gum. The measurement lasts less than 10 seconds. The device is non-invasive.
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Intervention code [1]
325785
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Early detection / Screening
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Intervention code [2]
325869
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Treatment: Devices
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Comparator / control treatment
It is a split mouth study, where up to 3-4 teeth will be the 'test' group and the rest of the teeth will be 'controls'. Participants will be asked to refrain from brushing the 'test' group teeth for 21 days. Participants will be asked to brush the 'control' group teeth as per normal routine.
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Control group
Active
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Outcomes
Primary outcome [1]
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Accuracy of detection of gum disease Gingivitis using a novel ultrasound device will be determined by comparing results from this device to the gold standard detection method of the Gingival Index
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Assessment method [1]
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Timepoint [1]
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2-3 weeks after commencement of study
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Secondary outcome [1]
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Severity of gingivitis determined using the Gingival Index
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Assessment method [1]
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Timepoint [1]
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Recorded every week for six weeks
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Secondary outcome [2]
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Severity of gingivitis determined using the gingival color change
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Assessment method [2]
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Timepoint [2]
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Recorded every week for six weeks
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Secondary outcome [3]
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Severity of gingivitis determined using the gingival plaque index
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Assessment method [3]
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Timepoint [3]
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Recorded every week for six weeks
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Eligibility
Key inclusion criteria
(i) in good health, (ii) minimum 3 contiguous right maxilla posterior teeth free of periodontal pockets of >3mm, and (iii) absence of gingivitis.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
(i) periodontitis or peri-implantitis, (ii) having active dental caries, (iii) wearing a partial plate replacing upper teeth, (iv) undergoing orthodontic treatment, having, (v) current pregnancy or nursing, (vi) a smoker or vaper, (vii) having active infection in oral cavity, (viii) had antibiotics or used a chlorhexidine mouthwash in the previous month.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
t-tests, Analysis of Variation (ANOVA)
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
10/05/2023
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Actual
22/06/2023
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Date of last participant enrolment
Anticipated
9/05/2024
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Actual
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Date of last data collection
Anticipated
15/06/2024
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Actual
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Sample size
Target
25
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Accrual to date
3
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Periomedic Limited
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Address [1]
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Basestation, 148 Durham Street, PO Box 13256, Tauranga Central, New Zealand, 3141
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Country [1]
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Periomedic Limited
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Address
Basestation, 148 Durham Street, PO Box 13256, Tauranga Central, New Zealand, 3141
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Committee (HDEC), New Zealand
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Ethics committee address [1]
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133 Molesworth Street
Thorndon
Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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20/04/2023
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Approval date [1]
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01/05/2023
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Ethics approval number [1]
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2023 EXP 16744
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Ethics committee name [2]
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Northern B Health and Disability Ethics Committee
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Ethics committee address [2]
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [2]
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New Zealand
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Date submitted for ethics approval [2]
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11/05/2023
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Approval date [2]
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15/05/2023
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Ethics approval number [2]
315165
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2023 EXP 16744
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Summary
Brief summary
Recently the World Health Organization (WHO) estimated that over one billion people worldwide have severe periodontitis which is also associated with adverse pregnancy outcomes, cardiovascular diseases, type 2 diabetes mellitus, respiratory disorders, fatal pneumonia in hemodialysis patients, chronic renal disease and metabolic syndrome. Early diagnosis at the superficial and reversible stage of disease (gingivitis) greatly improves the chances of successful treatment, prevents irreversible gingiva damage, and reduces treatment costs. We have developed a novel device that has shown promising results in the diagnosis of periodontal disease in a clinical trial (n=10, International Clinical Trials Registry Platform, Universal Trial Number (UTN) - U1111-1235-
6623). In this project, we aim to prove that the device can detect periodontal disease early, during early gingivitis.
Gingivitis is defined as reversible inflammation of the gingiva, limited to soft tissue without involving bone and presenting as visible inflammation – red, swollen, bleeding gums. Since 1965, experimental gingivitis has routinely been used as a clinical model for studying inflammation, as it can be induced by asking participants to refrain from brushing their teeth for 21 days, and spontaneously resolves after 7 to 14 days with complete healing once the participants resume toothbrushing(Löe, Theilade et al. 1965). Gingivitis affects over 90% of the world population and precedes bone loss, where gingivitis has progressed to periodontitis. Our novel device has been able to detect conditions corresponding to early and established periodontitis.
Aim: demonstrate that the Periomedic ultrasound device can detect periodontal disease during early gingivitis.
Objectives: correlate conventional measures of gingivitis (gingival bleeding index, colour change, plaque index) with ultrasound measurements of tissue elasticity, during the establishment and the resolution phases of experimental gingivitis.
Diagnosis of periodontal disease has shown little change in over one hundred years and rests upon the use of physical probing around the gums combined with the use of radiography. These diagnostic tests require significant training and infrastructure and are often not appropriate for use by community health workers in primary care. Significant irreversible tissue lost must have occurred before periodontal disease can be detected by these means. Our study aims to develop a new approach to early diagnosis of gum disease, that could be applied by non-dental community health workers or dental therapists, particularly those working with “at risk”, remote or rural communities. We anticipate that early diagnosis would lead to earlier, less invasive and more affordable treatment for these populations.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Warwick Duncan
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Address
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Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
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Country
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New Zealand
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Phone
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+64 3 479 7110
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Warwick Duncan
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Address
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Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
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Country
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New Zealand
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Phone
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+64 3 479 7110
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Warwick Duncan
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Address
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Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
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Country
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New Zealand
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Phone
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+64 3 479 7110
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data will be kept confidential for commercial purposes.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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