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
- Conditions
- Tandvleesontsteking 25%, tandplaque, tandvleesbeschadigingendental plaque and gingival abrasionGingival bleeding
- Registration Number
- NL-OMON38790
- Lead Sponsor
- ACTA Dental Research B.V. (ADR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
- 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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the level of Bleeding On Marginal Probing (BOMP)<br /><br>Van der Weijden et al. 1994</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Level of dental plaque<br /><br>Turesky modification of the Quigley & Hein plaque index further modified by<br /><br>Lobene 1982<br /><br><br /><br>2. Level of gingival abrasion<br /><br>Gingival Abrasion Score, Van der Weijden et al. 2004<br /><br><br /><br>3.Subjects* attitude towards the study products</p><br>