|- candidate number||3913|
|- NTR Number||NTR1429|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2008|
|- Secondary IDs||07/152 MEC AMC |
|- Public Title||The effect of 1% chlorhexidine gel compared to 0.12% chlorhexidine gel- toothpaste or 0.2% chlorhexidine mouthwash or regular toothpaste in a 3 day non-brushing model on plaque accumulation. |
|- Scientific Title||The effect of 1% chlorhexidine gel compared to 0.12% chlorhexidine gel- toothpaste or 0.2% chlorhexidine mouthwash or regular toothpaste in a 3 day non-brushing model on plaque accumulation.|
|- ACRONYM||DAGMAR 2 Daily Application of a Gingival Maintenance Antimicrobial Regimen 2|
|- hypothesis||Tray application of 1% chlorhexidine gel has more than 15% better effect on de novo plaque accumulation compared to tray application of regular toothpaste or 0.12% chlorhexidine gel- toothpaste in a 3 day non-brushing model.|
|- Healt Condition(s) or Problem(s) studied||Dental plaque, Dentifrice, Mouthrinse|
|- Inclusion criteria||1. >= 18 years |
2. Systemically healthy
3. >= 20 teeth
4. at least 5 teeth per quadrant
5. No pockets >= 5 mm
6. No orthodontic appliances
7. No removable (partial) dentures.
|- Exclusion criteria||1. Use of medication possibly influencing normal gingival health.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-sep-2007|
|- planned closingdate||12-okt-2007|
|- Target number of participants||120|
|- Interventions||Tray application of 1% chlorhexidine gel or 0.12% chlorhexidine gel-toothpaste or regular toothpaste twice daily during 2 minutes or rinsing with 0.2% chlorhexidine mouthwash twice daily during 1 minute, during a 3 day non-brushing period.|
|- Primary outcome||Quigley & Hein plaque-index after 3 days (72 hours) of de novo plaque accumulation.|
|- Secondary outcome||Bleeding on marginal probing (BOMP) index after 3 days (72 hours) and outcomes are results from the VAS questionnaire to evaluate the subject's attitude towards to the used products.|
|- Timepoints||-Professional oral profylaxis;|
-Measurements (3 days after profylaxis).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| D.E. Slot|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||Academic Center Dentistry Amsterdam (ACTA)|
(Source(s) of Monetary or Material Support)
|GlaxoSmithKline, Dentaid Benelux|
|- Brief summary||Background: |
Maintaining an adequate low level of plaque through daily tooth brushing is often not feasible. Chemotherapeutic agents as an adjunct to mechanical plaque control would be valuable. Chlorhexidine has proven to be an effective inhibitor of plaque accumulation. Lower concentrations of chlorhexidine might decrease the chances for adverse effects.
The purpose of the study is to assess the effect of tray application of 1% chlorhexidine gel on de novo plaque accumulation compared to the effect of 0.12% chlorhexidine gel- toothpaste or a regular toothpaste tray application or rinsing with 0.2% cholhexidine mouthwash in a 3 day non-brushing model.
Material and methods:
The study is designed as a single blind, randomized 4-arm parallel clinical trial. During a 3 day non brushing period, one group will use gel twice daily applied with a fluoride tray. This gel contains 1% chlorhexidine. One group will use 0.12% chlorhexidine gel-toothpaste and one group a regular toothpaste twice daily also applied with a fluoride tray. One group will use 0.2% chlorhexidine mouthwash, rinsing twice daily with 10 ml. 3 Days later all subjects will return. After disclosing, plaque accumulation is scored. Also the bleeding on marginal probing is done. Subsequently all subjects receive a questionnaire to evaluate their attitude towards the used products using Visual Analogue Scales (VAS-scores). After the experimental period, habitual oral hygiene procedures may be resumed.
120 Subjects, ¡Ý18 years, systemically healthy, with at least 5 teeth per quadrant and no pockets ¡Ý5 mm, no orthodontic appliance or removable (partial) denture.
Tray application of 1% chlorhexidine gel or 0.12% chlorhexidine gel-toothpaste or regular toothpaste twice daily during 2 minutes or rinsing with 0.2% chlorhexidine mouthwash twice daily during 1 minute, during a 3 days non-brushing period.
Time load for subjects:
Maximum 4 minutes of product uses per day during 3 days and a total of 40 minutes professional prophylaxis and clinical assessment.
Risk for subjects:
Quigley & Hein plaque index assessed after 3 days of de novo plaque accumulation.
|- Main changes (audit trail)|
|- RECORD||4-sep-2008 - 13-jan-2010|