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van CCT (UK)

van CCT (UK)

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

- candidate number15371
- NTR NumberNTR4158
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2013
- Secondary IDsNL44738.018.13 CCMO
- Public TitleEffect 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
- Scientific TitleSoft rubber bristles interdental cleaner compared to interdental brushes
- ACRONYMSoft Rubber Bristles interdental cleaner Evaluation Trail (SORBET)
- hypothesisWhat 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 systematically healthy students/volunteers with a level of ≥25% gingival bleeding but without periodontitis
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Male and female
2. Right handed brusher and writer
3. Age 18-35 years
4. Classified as systemically healthy, assessed by medical questionnaire
5. Non-smokers (Lie et al. 1998), definition non-smoker: <1 cigarette every day for at least one year
6. Minimum of 20 natural teeth: at least 5 evaluable in each quadrant of the lower jaw available
7. DPSI 0-3- (appendix 15.4)
8. ≥25% BOMP at the moment of clinical screening
9. Buccal accessible interdental spaces to apply the interdental devices either a rubber bristles interdental cleaner or interdental brush
10. Willing and able to give written informed consent
11. Agree to brush with a manual toothbrush for the duration of the study
12. Agree to refrain from brushing the lower jaw for 21 days in the experimental phase
13. Agree to brushing and interdental cleaning between 2 and 3 hours prior to clinical measurements in the screening-, experimental- and treatment phases
14. Agree to refrain from rinsing with an antiseptic mouthwash during the study
15. Agree to refrain from using any other interdental devices during the study
16. Agree to refrain from using >3 chewing gums daily during the study
17. No medication except for birth control pills
- Exclusion criteria1. Anyone presenting with a probing depth ≥ 5mm with bleeding on probing and attachment loss ≥ 2 mm
2. Overt dental caries
3. Usage of any interdental device as part of regular daily oral care
4. Left-handed brusher and writer
5. Smokers
6. DPSI 3+-4 (appendix 15.4)
7. Removable (partial) dentures
8. Crowns, bridges and implant supported restorations
9. Removable night guard
10. Oral and/or peri-oral piercings
11. Apparent oral lesions (aphthous ulcers excluded)
12. Presence of orthodontic banding (except for lingual retention wire)
13. Dental student or dental professional
14. Participation in a clinical study within the previous 30 days

General health and use of medication:
15. Self-reported pregnancy or breastfeeding
16. Use of antibiotics during the last 3 months
17. Need of antibiotic prophylaxis prior to dental treatment
18. Use of anti-inflammatory drugs on a regular basis
19. Evidence of any systemic disease or compromised health condition
20. Adverse medical history or long-term medication
21. Prescribed medication (except for anti-contraceptives birth control pills)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-sep-2013
- planned closingdate5-dec-2013
- Target number of participants45
- InterventionsPositive control:
Soft rubber bristles interdental cleaner (RBC)

Negative control:
Interdental brushes (IDB),
- Primary outcomeThe primary outcome is the level of Bleedning On
- Marginal Probing (BOMP)
Van der Weijden et al. 1994
- Secondary outcomeThe secundary outcome is:
- The level of dental plaque
Turesky modification of the Quigley&Hein plaque index further modified by Lobene 1982
- Level of gingival abrasion
Gingival Abrasion (GAS), Van der Weijden et al. 2004
- TimepointsScreening
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)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA-ADR
- Funding
(Source(s) of Monetary or Material Support)
Sunstar Suisse SA
- PublicationsN/A
- Brief summaryThe 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).
- Main changes (audit trail)
- RECORD5-sep-2013 - 29-sep-2013

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