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Clinical trial comparing the efficacy of interdental oral irrigation devices with interdental brushes in adults with gingivitis

Comparison study, identifying statisticial differences in biofilm removal and gingival inflamation markers based upon the cleaning efficacy of interdental oral irrigation and interdental brushes in adults with gingivitis

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001684819
Enrollment
9
Registered
2021-12-09
Start date
2023-04-07
Completion date
2024-08-16
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This clinical trial is designed to compare the efficiency in the removal of interdental plaque and interdental gum.. Participants are instructed on how to use each device correctly and safely. We use plaque and bleeding scores to determine which healthbrushes and an oral irrigation device (water flosser) to clean in between your teeth.

Interventions

Participants will be given taylored oral hygiene instruction on each device, either an interdental brush or an oral irrigation device prior to use. The interdental brush is in essence like a small "bottle" brush that comes in various sizes. The size specific to each individual trial participant will be professionally sized by the trial oral hygiene educators. The oral irrigation device is a high pressure water streaming device which focuses a controlled amount of water pressure on the interdenta

Participants will be given taylored oral hygiene instruction on each device, either an interdental brush or an oral irrigation device prior to use. The interdental brush is in essence like a small "bottle" brush that comes in various sizes. The size specific to each individual trial participant will be professionally sized by the trial oral hygiene educators. The oral irrigation device is a high pressure water streaming device which focuses a controlled amount of water pressure on the interdental spaces. Both devices are designed to remove, food debris, biofilm (dental plaque) and remove bacterial toxins to the betterment of gingival health. Both devices are to be used in the participants home bathroom enviroment. The oral hygiene educators have been calibrated and will have access to a "script" for the fundamental messages on safe and correct use that each participant must receive. The participant will be randomly allocated a device by the oral educator and this information will be noted by them and it is highly important that the participants don't let the clinical assessors know which device they are using at any time. Participants will only be taught about either the interdental brushes or oral irrigation device prior to them commencing use with that implement for the specified time by the Oral hygiene educators. The educators are year 2 Dentistry students who are already AHPRA registered Oral Health Therapists with at least 3 years experience each as OHT's. One to one personalised oral hygiene education for each device will be implemented in the dental chair with mirrors and the "touch to teach" method of education i.e. show, demostrate physically and the patient explains and demonstrates to the educator themselves to verify appropriate uptake of the correct technique. This session is expected to take no more than 20-25 minutes. The participant is expected to use each device at least once a day at a time convenient to them. The duration of use for each device is expected to be not more than 4-5 minutes per day for a four week period. The patient then returns, has their clinical parameters taken once again. At this point the participant is asked to return to the Interdental cleaning method they used before the trial for a "washout period" of two weeks. The the participant will return and receive the subsequent oral hygiene education for the device they have not yet used. The adherance of the participant to the regime is self-motivated on their part. This is part of what we assess via the qualitative questionaire on their last visit of the trial to determine which device they found the easiest to use and felt was the most effective in cleaning inbetween their teeth. The total timeline for the trial will be 5 visits over 12 weeks.

Sponsors

Sydney Dental Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Oral Disease status/ or disease group for study: Embrasure space of 2 or 3. PSR code<=3. 2. Gender: no restrictions 3. Age range: >18 years 4. At least 24 natural teeth 5.Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Exclusion criteria

1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. 2. Participants with a history of active periodontal disease with a PSR code of 4. 3. Participants with a history of diabetes, tobacco smoking, xerostomia (dry mouth), any form of chronic inflammatory disease. 4. Participants who have taken antibiotics within the past six weeks. 5. Participants currently experiencing psychological illness or other conditions which may interfere with their ability to understand the study requirements or interfere with their motivation to participate in the study, or the evaluation of the study outcome. 6. As the following medication(s) can have interactive effects and may interfere with the participant’s ability to meet the study requirements, they cannot be administered during the clinical study (anticoagulants, anti-convulsant, immunosuppressants, tricyclic antidepressants) 7. Participants that have a medical condition which inhibits their ability to safely use the OH tools, e.g. multiple sclerosis, Parkinson’s disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 7, 2026