None listed
Conditions
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.
Interventions
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. Assessmen
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.
Sponsors
Periomedic Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed