Periodontal disease Oral Health Periodontal disease, unspecified
Conditions
Interventions
Eligible participants will be randomly allocated to receive one of 4 treatment regimens, according to a predetermined randomisation schedule (2 treatments, 1 study visit – split mouth). The allocated
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form 2. Aged at least 18 years 3. Understands and is willing, able and likely to comply with all study procedures and restrictions 4. Susceptible to periodontal disease and have stability of the periodontium on examination (in supportive periodontal phase of treatment) 5. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
Exclusion criteria
Exclusion criteria: 1. Current or recurrent disease/dental pathology that could affect the assessments 2. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study products or procedures 3. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 4. Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit 5. Personnel A member of the study site or a family relative. The study site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital and a Specialist Periodontal Practice. Employees of the sites are not eligible to participate 6. Any participant who, in the judgement of the investigator, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient experience (pain/discomfort, vibration, noise) during ultrasonic tooth scaling comparing the devices with the use of room temperature water. Measured using VAS score lines immediately following treatment of each side of the mouth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient experience (pain/discomfort, vibration, noise) during ultrasonic tooth scaling using a piezo-device irrigated by warm water compared to a magnetostrictive-device with room temperature water for irrigation. Measured using VAS score lines immediately following treatment of each side of the mouth. | — |
Countries
United Kingdom, Wales
Outcome results
None listed