No registrations found.
ID
Source
Brief title
Health condition
Gingivitis
Gingival abrasion
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bleeding upon Pocket probing (BOPP)
Secondary outcome
- Bleeding On Marginal Probing (BOMP)
- Modfied gingival abrasion index
- Subjects'attidue towards the study protocol and study products according to a questionnaire
- Clinical photos taken of the buccal aspect of teeth from cuspid to cuspid
Background summary
The toothbrush does not adequately reach the interproximal surfaces of the teeth. As gingivitis and periodontitis are usually more pronounced in the interdental areas than on the oral or facial surfaces in susceptible patients. The rationale is to determine the effectiveness of product Water Flosser with water and interdental brush on gingival bleeding and gingival abrasion and to evaluate subjects’ attitudes towards the used products in this study.
Study objective
To assess the effect of the commercially available Water Flosser compared to interdental brushes evaluating gingival bleeding and gingival abrasions in a group of systemically healthy participants with gingivitis but without periodontitis.
Study design
Screening
Visit 1: baseline
Visit 2: week 2
Visit 3: week 4
Intervention
Test groep: Waterpik® with a classic standard jet tip (with water) + manual toothbrush with the use of a regular toothpaste
Control groep: Interdental brush Interprox+ manual toothbrush with the use of a regular toothpaste
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
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.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5893 |
| NTR-old | NTR6081 |
| CCMO | NL58265.018.16 |
| OMON | NL-OMON43014 |