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van CCT (UK)


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van CCT (UK)


The effect of application of 0.12% chlorhexidine gel-toothpaste compared to 0.12% chlorhexidine mouthwash and regular toothpaste in a 3 day non-brushing model on plaque accumulation.


- candidate number1352
- NTR NumberNTR274
- ISRCTNISRCTN57974544
- Date ISRCTN created1-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR14-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of application of 0.12% chlorhexidine gel-toothpaste compared to 0.12% chlorhexidine mouthwash and regular toothpaste in a 3 day non-brushing model on plaque accumulation.
- Scientific TitleThe effect of application of 0.12% chlorhexidine gel-toothpaste compared to 0.12% chlorhexidine mouthwash and regular toothpaste in a 3 day non-brushing model on plaque accumulation.
- ACRONYMDAGMAR Daily Application of a Gingival Maintenance Antimicrobial Regimen
- hypothesisTray application of 0.12% chlorhexidine gel-toothpaste has more than 15% better effect on ¡®de novo¡¯ plaque accumulation compared to tray application of regular toothpaste in a 3 day non-brushing model.
- Healt Condition(s) or Problem(s) studiedDental plaque
- Inclusion criteria1. > 18 years;
2. Systemically healthy;
3. >= 20 teeth;
4. 5 teeth per kwadrant;
5. No pockets >5 mm;
6. No orthodontic appliances;
7. No removable (partial) dentures.
- Exclusion criteria1. Use of medication possibly influencing normal gingival health;
2. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-sep-2005
- planned closingdate3-okt-2005
- Target number of participants90
- InterventionsTray application of 0.12% chlorhexidine gel-toothpaste twice daily during 2 minutes or tray application of regular toothpaste twice daily during 2 minutes or rinsing with 0.12% chlorhexidine mouthwash twice daily during 1 minute, during a 3 day non-brushing period.
- Primary outcomeQuigley & Hein plaque-index after 3 days (72 hours) of ¡®de novo¡¯ plaque accumulation.
- Secondary outcomeResults from the VAS questionnaire to evaluate the subject¡¯s attitude towards to the used products.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES D.E. Slot
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Dentaid Benelux, Hogeschool INHOLLAND, school of health in Diemen
- Publications1. Int J Dent Hyg. 2007 Feb;5(1):45-52.
2. J Periodontol. 2008 Aug;79(8):1395-400.
- Brief summaryBackground:
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.

Aim:
The purpose of the study is to assess the effect of tray application of 0.12% chlorhexidine gel-toothpaste on ¡®de novo¡¯ plaque accumulation compared to the effect of rinsing with 0.12% chlorhexidine mouthwash and tray application of a regular toothpaste in a 3 day non-brushing model.


Material and methods:
The study is designed as a single blind, randomized 3-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 0.12% chlorhexidine. One group will use a regular toothpaste twice daily also applied with a fluoride tray. One group will use 0.12% chlorhexidine mouthwash, rinsing twice daily with 15 ml. 3 Days later all subject will return. After disclosing, plaque accumulation is scored. 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.


Population:
90 Subjects, >18 years, systemically healthy, with at least 5 teeth per quadrant and no pockets >5 mm, no orthodontic appliance or removable (partial) denture


Intervention:
Tray application of 0.12% chlorhexidine gel-toothpaste twice daily during 2 minutes or tray application of regular toothpaste twice daily during 2 minutes or tray or rinsing with 0.12% 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:
None.

Endpoint:
Quigley & Hein plaque index assessed after 3 days of ¡®de novo¡¯ plaque accumulation.
- Main changes (audit trail)
- RECORD14-sep-2005 - 11-sep-2008


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