The effect of an interdental brush and a water flosser on gingival bleeding and gingival abrasions. A 4 weeks randomized clinical trial.

Completed

Conditions: Gingival bleeding and gingival abrasion
bleeding gums
Inflammation of the gums

Registration Number: NL-OMON43014

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: 80

Inclusion Criteria

- Male and female
- Age 18-65 years
- Right handed brusher and writer
- Classified as systemically healthy
- Non-smokers (Lie et al. 1998) definition non-smoker: <1 cigarette every day for at least one year
- Moderate gingivitis (level of gingival bleeding assessed BOPP *50%)
- Minimum of 20 natural teeth, at least 5 evaluable in each quadrant available
- Buccal accessible interdental spaces to apply the interdental brush
- The interdental brushes must fit between at least 4 spaces per quadrant when approached buccally, of these 2 should be interdental spaces involving at least two spaces of the molar area.
- The other 2 spaces can be between the pre-molars, cuspid and incisors.;The participant is willing during the study:
- able to give written informed consent
- to brush with a manual toothbrush for the duration of the study
- to brush between 2 and 3 hours prior to clinical measurements in the screening-, experimental- and treatment phases
- refrain from rinsing with an antiseptic mouthwash during the study
- refrain from using any other interdental devices during the study
- refrain from excessive gum use (using >3 chewing gums daily) during the study

Exclusion Criteria

- Pockets deeper than 5mm (excluding distal of the last molars)
- Overt dental caries
- Oral lesions
- Usage of any interdental device as part of regular daily oral care
- Removable (partial) dentures
- Crowns, bridges and implant supported restorations
- Removable night guard
- Orthodontic banding (except for lingual retention wire)
- Oral and/or peri-oral piercings
- Dental student or dental professional
- Participation in a clinical study within the previous 30 days ;General health:
- Medication, except for birth control pills
- 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

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 upon Pocket Probing (BOPP). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary outcome is:<br /><br><br /><br>- Bleedingscores assessed with the Bleeding On Marginal Probing (BOMP)<br /><br>- Abrasion scores assessed with the Modified gingival abrasion index<br /><br>- Subjects'attidue towards the study protocol and study products according to<br /><br>the VAS<br /><br>- Clinical photos taken of the buccal aspect of teeth from cuspid to cuspid</p><br>