|- candidate number||8873|
|- NTR Number||NTR2683|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jan-2011|
|- Secondary IDs||2167 Kliniek voor Parodontologie Rotterdam|
|- Public Title||CoCy (Conical vs Cylindrical ragers).|
|- Scientific Title||Conical vs Cylindrical: A study on efficiency of interdental brushes.|
|- hypothesis||Cylindrical shaped interdental brushes removes more dental plaque at the approximal surfaces than conical shaped.|
|- Healt Condition(s) or Problem(s) studied||Dental plaque, Gingival health, Interdental brushes|
|- Inclusion criteria||≥ 18 years;|
2. Periodontal recall client from Kliniek voor Parodontologie Rotterdam;
3. Systemically healthy;
4. No participation in other oral heatlh care studies.
|- Exclusion criteria||1. The absence of pregnancy and systemic diseases such as aids, cirrhosis, diabetes;|
2. The absence of any adverse medical history or long-term medication;
3. Or any physical condition that limits manual dexterity.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-jan-2011|
|- planned closingdate||30-jul-2011|
|- Target number of participants||60|
|- Interventions||Group 1: Conical interdental brushes;|
Group 2: Cylindrical interdental brushes.
The intervention will have a duration of 3-4 months in which the participants have 2 visits.
|- Primary outcome||Plaque Index.
|- Secondary outcome||1. BOMP (bleeding on marginal probing) - Van der Weijden 1994;|
2. Periodontal status including PPD (Probing pocket depth) and gingival recession.
|- Timepoints||1. Visit: Plaque Index BOMP and periodontal status; professional recall treatment;|
2. Visit: Supra gingival scaling and polishing, Instruction for use of interdental aid including the assigned interdental brushes;
3. Visit: Plaque Index BOMP and periodontal status.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| H.C. Larsen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||Kliniek voor Parodontologie Rotterdam|
(Source(s) of Monetary or Material Support)
|Kliniek voor Parodontologie Rotterdam, Lactona|
|- Brief summary||Interdental brushes are the most effective way to remove dental plaque from the approximal surfaces (Slot et al. 2008). Two shapes of interdental brushes are on the market, conical and the cylindrical.|
In this study two groups were instructed to the use of either the conical or the cylindrical shape interdental brushes for a period of 3-4 months. The subjects were instructed not to deviate further from the domestic oral hygiene. It was registered if the subjects were using electrical or manual tooth brush and if they were right or left handed. In order to evaluate which interdental brush shaped is superior.
|- Main changes (audit trail)|
|- RECORD||4-jan-2011 - 7-nov-2012|