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What's patients' favorite volume mouthwash to rinse with?


- candidate number9154
- NTR NumberNTR2775
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-feb-2011
- Secondary IDsPAROT&P201101 
- Public TitleWhat's patients' favorite volume mouthwash to rinse with?
- Scientific TitleWhat's patients' favorite volume mouthwash to rinse with?
- ACRONYM
- hypothesisPatients' favorite volume mouthwash for rinsing is 15ml.
- Healt Condition(s) or Problem(s) studiedDental plaque
- Inclusion criteria≥ 18 years.
- Exclusion criteriaN/A
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate28-feb-2011
- Target number of participants60
- InterventionsThe subjects will rinse with five different volumes mouthwash in randomized order: 5ml, 10ml, 15ml, 20ml and 30ml. One week later, they will rinse again with the five volumes in the same randomized order and with the same mouthwash.
- Primary outcomePatients' satisfaction, VAS score.
- Secondary outcomeN/A
- TimepointsWeek 0, week 1.
- 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 Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
GABA International AG
- PublicationsN/A
- Brief summaryBackground of the study:
Maintaining an adequate low level of plaque through daily tooth brushing is often not feasible. Mouthwashes as an adjunct to mechanical plaque control would be valuable. Various mouthwash manufactures advises different volumes for rinsing. Till so far no studies are available about the volume mouthwash for rinsing and patientsí satisfaction.

Aim of the study:
The purpose of the study is to assess patientsí satisfaction when they rinse for 30 seconds with 5ml, 10ml, 15 ml, 20ml and 30ml mouthwash. In order to investigate whatís patients favorite volume mouthwash to rinse with.

Material and methods:
The study is designed as a single blind, randomized 5-arm cross-over clinical trial. On one day 60 subjects will rinse, each one, with five different volumes mouthwash in randomized order: 5ml, 10ml, 15ml, 20ml and 30ml. With each volume they have to rinse for 30 seconds. Subsequently all subjects receive a questionnaire to evaluate their attitude towards the used volumes using Visual Analogue Scales (VAS-scores). One week later, they will rinse again with the five volumes in the same randomized order and with the same mouthwash.
- Main changes (audit trail)
- RECORD22-feb-2011 - 7-nov-2012


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