What is the gingival healing effect of a rubber bristles interdental cleaner compared to an interdental brushes after an 3-week non-brushing period (experimental gingivitis) measured with the Bleeding on Marginal Probing (BOMP) index in a group of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Tandvleesontsteking 25%, tandplaque, tandvleesbeschadigingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of Bleeding On Marginal Probing (BOMP)
Van der Weijden et al. 1994
Secondary outcome
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
Background summary
The efficacy in plaque removal on average following a single brushing exercise
is only a reduction from baseline plaque scores of 42% (Slot et al. 2012). In
populations that use toothbrushes, the interproximal surfaces of the molars and
premolars are the predominant sites of residual plaque. Removal of plaque from
these surfaces remains a valid objective because, in patients susceptible to
periodontal disease, gingivitis and periodontitis are usually more pronounced
in this interdental area than on oral or facial aspects (Löe 1979).
Toothbrushing alone does not reach the interproximal areas of teeth, resulting
in parts of the teeth that remain unclean. Good interdental oral hygiene
requires a device that can penetrate between adjacent teeth.
Interdental brushes are frequently recommended by dental professionals to
patients with sufficient space between their teeth. Interdental brushes are
small, specially designed brushes for cleaning between the teeth.
Slot et al. (2008) systematically reviewed the literature to determine the
effectiveness of interdental brushes used as adjuncts to toothbrushes in terms
of the presence of plaque and clinical parameters of periodontal inflammation
in patients with gingivitis or periodontitis. And concluded that as an adjunct
to brushing, the IDB removes more dental plaque than brushing alone
The Soft-Picks interdental cleaners resemble interedntal brushes, but do not
have metal or nylon fiber bristles. Instead, they have small elastomeric
fingers protruding perpendicularly from a plastic core. Till so far only one
publication is available presenting a parallel design using this rubber
interdental bristles cleaner and it was compared to an interdental brush. It
concluded that regarding gingivitis reduction the interdental brush superior
but for plaque reduction and removal both inderdental devices are comparably
effective (Yost et al. 2006).
Study objective
What is the gingival healing effect of a rubber bristles interdental cleaner
compared to an interdental brushes after an 3-week non-brushing period
(experimental gingivitis) measured with the Bleeding on Marginal Probing (BOMP)
index in a group of systemically healthy students/volunteers with a level of
*25% gingival bleeding but without periodontitis?
Study design
This study is a parallel, examiner-blind, randomly assigned split-mouth design.
Pre- screening
Screening
Visit 1 Familiarisation phase (week 1)
Visit 2 Experimental gingivitis phase (week 3)
Visit 3 Treatment phase (week 6)
Visit 4 Treatment phase (week 7 )
Visit 5 Treatment phase (week 8)
Visit 6 Treatment phase (week 10)
Intervention
Soft rubber bristeles interdental cleaner
Study burden and risks
Neither immediate nor long-range physical risks are involved.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44738.018.13 |
| OMON | NL-OMON20304 |