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A pilot study to assess the level of gum tissue micro abrasion after the use of manual toothbrushes with a different leven of end-rounded filaments. End-Rounding and Brush Abrasion (ERBA).


- candidate number12409
- NTR NumberNTR3451
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mei-2012
- Secondary IDsNL40530.018.12 CCMO
- Public TitleA pilot study to assess the level of gum tissue micro abrasion after the use of manual toothbrushes with a different leven of end-rounded filaments. End-Rounding and Brush Abrasion (ERBA).
- Scientific TitleA pilot study to assess the level of gum tissue micro abrasion after the use of manual toothbrushes with a different leven of end-rounded filaments. End-Rounding and Brush Abrasion (ERBA).
- ACRONYMEnd-Rounding and Brush Abrasion (ERBA)
- hypothesisThe objective of this pilot study is to assess the effect of filament endrounding quality on gingival abrasion.
- Healt Condition(s) or Problem(s) studiedBrush Abrasion, Gum tissue
- Inclusion criteria1. ≥ 18 years;
2. Be in general good physical and oral health, as determined by the investigator/designee;
3. Agree not to participate in any other oral/dental products clinical study for the study duration;
4. Agree to refrain from the use of any non-study dentifrice or other oral hygiene products for the study duration;
5. Have a minimum of 5 evaluable teeth per quadrant;
6. Not have visual oral lesions.
- Exclusion criteria1. Self-reporting of pregnancy or nursing (women only);
2. Show evidence of periodontitis or within an active treatment for periodontal disease;
3. Show evidence of carious lesions requiring immediate treatment;
4. Having taken antibiotics within 2 weeks before the first treatment period or anticipation of taking antibiotics during the course of the study;
5. Have orthodontic appliances or removable partial dentures;
6. Oral piercings;
7. Show evidence of any disease or conditions that could be expected to interfere with examination or outcomes of the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jun-2012
- planned closingdate28-jun-2012
- Target number of participants48
- InterventionsFirst for each leg of the cross-over by type of end-rounded bristle (group A, B, or C) secondly assignment by brush type to professional brushing in 2 contra-lateral (1st and 3rd or 2nd and 4th) quadrants. Every visit the Abrasion is measured by the examiner. The dental hygienist will brush with two different brushes, contra lateral (1st and 3rd or 2nd and 4th quadrant), finally the abrasion is measured.
Group A= 0% end-rounded Oral- B indicator;
Group B= 40- 50% end-rounded Oral- B indicator;
Group C= 90 % end-rounded Oral- B indicator.
- Primary outcomeThe primary outcome is Gigival Abrasion Score (Danser et al. 1998).
- Secondary outcomeN/A
- TimepointsScreening;
In total there are three assessments:
1. Visit 1- week 1 (tuesday or thursday);
2. Visit 2- week 2 (tuesday or thursday);
3. Visit 3- week 3 (tuesday or thursday).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.A. Weijden, van der
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA-ADR
- Funding
(Source(s) of Monetary or Material Support)
Procter&Gamble Company Cincinnati, Ohia USA
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-mei-2012 - 7-nov-2012


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