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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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 CONDITION: Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Oral Health;Interdental biofilm;Gingivitis;Oral Biofilm ;Periodontal disease; ; Oral Health ; Interdental biofilm ; Gingivitis ; Oral Biofilm ; Periodontal disease PRIMARY OUTCOME: Any differences in the removal of oral biofilm interdentally by interdental brushes compared to oral irrigation devices. ; Gingival inflammation assessed using the Modified papilla bleeding index.; Periodontal screening and recording (PSR) indicies will measure gingival coding according to this indicies, Rustogi modified navy plaque index will assess dental biofilm quality and quantity measurements. ; All of these outcomes will be assessed as a composite outcome.[Visit 2 ‐ Initial clinical parameters recorded (baseline); Visit 3 ‐ Clinical parameters recorded 4 weeks post‐commencement of intervention 1; Visit 5 ‐ Clinical parameters recorded 4 weeks post‐commencement of intervention 2; ] SECONDARY OUTCOME: Investigate participant preferences as a composite secondary outcome by using a ethics approved specific questionaire to pose questions regarding the ease of use for each device, which device is their preferred and which device motivates them more to clean interdentally. [This data is collected at the final appointment 12 weeks post‐baseline via an ethics approved questionaire] 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.
Epistemonikos ID: c1269423056c33f484265ff57eb3617606616ef2
First added on: Aug 25, 2024