NL-OMON38790CompletedPhase 4
Effect of a soft rubber bristles interdental cleaner compared to an interdental brushes on dental plaque, gingival bleeding and gingival abrasion in a split- mouth experimental gingivitis model - Soft rubber bristles interdental cleaner compared to interdental brushes
ACTA Dental Research B.V. (ADR)0 sites44 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Male and female - Students - 18 and 35 years - Right handed brusher and writer - Classified as systemically healthy, assessed by medical questionnaire - Minimum of 20 natural teeth: at least 5 evaluable in each quadrant of the lower jaw available - *25% BOMP at the moment of clinical screening - Accessible interdental spaces to apply a soft rubber interdental bristles cleaner and interdental brushes, with a minimum of five interdental spaces per quadrant when approached buccaly. ;- Willing and able to give written informed consent - Agree to refrain from brushing the lower jaw for 21 days in the experimental phase -Agree to refrain from brushing and interdental cleaning between 2 and 3 hours prior to clinical measurements in the screening-, experimental- and treatment phases - Agree to refrain from rinsing with an antiseptic mouthwash during the study - Agree to refrain from using other interdental devices during the study - Agree to refrain from using >3 chewing gums daily during the study
Exclusion Criteria
- •- Anyone presenting with a probing depth * 5mm with bleeding on probing and attachment loss * 2 mm. - Overt dental caries. - Usage of any interdental device as part of regular daily oral care. -Left-handed brusher and writer. - Smokers, definition non-smoker: <1 cigarette every day for at least one year. - Removable partial dentures. - Removable night guard. - Oral and/or peri-oral piercings. - Apparent oral lesions (aphthous ulcers excluded). - Presence of orthodontic banding (except for lingual retention wire). - Dental student or dental professional. - Participation in a clinical study within the previous 30 days ;General health and use of medication:
- •- Self-reported pregnancy or breastfeeding. - Use of antibiotics during the last 3 months. - Need of antibiotic prophylaxis prior to dental treatment. - Use of anti-inflammatory drugs on a regular basis. - Evidence of any systemic disease or compromised health condition. - Adverse medical history or long-term medication. - Prescribed medication (except for anti-contraceptives -birthcontrol pills)
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