Trial Review

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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.
Scientific title
A study to validate use of a novel ultrasound device in early detection of gingivitis.
Secondary ID [1] 309348 0
Nil known
Universal Trial Number (UTN)
U1111-1290-7155
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingivitis 329555 0
Condition category
Condition code
Oral and Gastrointestinal 326486 326486 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325785 0
Early detection / Screening
Intervention code [2] 325869 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 334329 0
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
Timepoint [1] 334329 0
2-3 weeks after commencement of study
Secondary outcome [1] 420259 0
Severity of gingivitis determined using the Gingival Index
Timepoint [1] 420259 0
Recorded every week for six weeks
Secondary outcome [2] 420721 0
Severity of gingivitis determined using the gingival color change
Timepoint [2] 420721 0
Recorded every week for six weeks
Secondary outcome [3] 420722 0
Severity of gingivitis determined using the gingival plaque index
Timepoint [3] 420722 0
Recorded every week for six weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
t-tests, Analysis of Variation (ANOVA)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/05/2023
Actual
22/06/2023
Date of last participant enrolment
Anticipated
9/05/2024
Actual
Date of last data collection
Anticipated
15/06/2024
Actual
Sample size
Target
25
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 25364 0
New Zealand
State/province [1] 25364 0
Otago

Funding & Sponsors
Funding source category [1] 313549 0
Commercial sector/Industry
Name [1] 313549 0
Periomedic Limited
Country [1] 313549 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Periomedic Limited
Address
Basestation, 148 Durham Street, PO Box 13256, Tauranga Central, New Zealand, 3141
Country
New Zealand
Secondary sponsor category [1] 315327 0
None
Name [1] 315327 0
Address [1] 315327 0
Country [1] 315327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312730 0
Northern B Health and Disability Committee (HDEC), New Zealand
Ethics committee address [1] 312730 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 312730 0
New Zealand
Date submitted for ethics approval [1] 312730 0
20/04/2023
Approval date [1] 312730 0
01/05/2023
Ethics approval number [1] 312730 0
2023 EXP 16744
Ethics committee name [2] 315165 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [2] 315165 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [2] 315165 0
New Zealand
Date submitted for ethics approval [2] 315165 0
11/05/2023
Approval date [2] 315165 0
15/05/2023
Ethics approval number [2] 315165 0
2023 EXP 16744

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125702 0
Prof Warwick Duncan
Address 125702 0
Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
Country 125702 0
New Zealand
Phone 125702 0
+64 3 479 7110
Fax 125702 0
Email 125702 0
warwick.duncan@otago.ac.nz
Contact person for public queries
Name 125703 0
Prof Warwick Duncan
Address 125703 0
Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
Country 125703 0
New Zealand
Phone 125703 0
+64 3 479 7110
Fax 125703 0
Email 125703 0
warwick.duncan@otago.ac.nz
Contact person for scientific queries
Name 125704 0
Prof Warwick Duncan
Address 125704 0
Faculty of Dentistry, University of Otago, 310 Great Kong Street, Dunedin, 9054
Country 125704 0
New Zealand
Phone 125704 0
+64 3 479 7110
Fax 125704 0
Email 125704 0
warwick.duncan@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be kept confidential for commercial purposes.


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.