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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38790

Enrollment

Registered

2013-09-03

Start date

2013-09-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tandvleesontsteking 25%, tandplaque, tandvleesbeschadigingen dental plaque and gingival abrasion Gingival bleeding

Interventions

Soft rubber bristeles interdental cleaner

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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:

Design outcomes

Primary

Measure	Time frame
The main study parameter is the level of Bleeding On Marginal Probing (BOMP) Van der Weijden et al. 1994	—

Secondary

Measure	Time frame
1. Level of dental plaque Turesky modification of the Quigley & Hein plaque index further modified by Lobene 1982 2. Level of gingival abrasion Gingival Abrasion Score, Van der Weijden et al. 2004 3.Subjects* attitude towards the study products	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)