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Evaluation of a dentifrice with natural ingredients in the prevention of plaque and gingivitis


- candidate number3050
- NTR NumberNTR1215
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2008
- Secondary IDsMEC 07/021 MEC
- Public TitleEvaluation of a dentifrice with natural ingredients in the prevention of plaque and gingivitis
- Scientific TitleEvaluation of a dentifrice with natural ingredients in the prevention of plaque and gingivitis
- ACRONYMN/A
- hypothesisThe dentifrice with natural ingredients (Verum) inhibit 10% less gingivitis compared to the placebo dentifrice over a period of 4 months in healthy subjects.
- Healt Condition(s) or Problem(s) studiedDental plaque, Gingivitis, Dentifrice
- Inclusion criteriaInclusion:
1. At least 5 evaluable teeth in each quadrant
2. Moderate gingivitis (ˇÝ40% bleeding on marginal probing)
- Exclusion criteriaExclusion:
1. Orthodontic banding or wires or partial dentures
2. Oral laesions or periodontol pocketsˇÝ 5mm
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-feb-2008
- planned closingdate3-jul-2008
- Target number of participants90
- InterventionsPre-experimental phase (3 weeks):
Brushing 2x a day:-Everclean toothpaste (a standard toothpaste)and -Aronal oko-dent toothbrush.
Rinsing 2x a day: - 0,2% Chloorhexidine mouthrinse (Corsodyl®) and 10 ml waterperoxide-oplossing (Bocasan®)
Experimental phase (4 months):
Brushing 2x a day:-Verum toothpaste(TEST OR CONTROL) in combination with the Aronal oko-dent toothbrush
- Primary outcomeBLEEDING ON MARGINAL PROBING (BOMP) ¨C Angular Bleeding Index (Van der Weijden 1994).
This score will be scored on the pre-experimental phase, baseline and at the final examination (after 4 months)
The gingiva is lightly dried with compressed air and lightly probed with a probe. The probe is inserted into the gingival crevice to a depth of approximately 2mm or until slight resistance is felt. The probe is run gently along the marginal gingival holding the probe at a an angle of approximately 60 degrees to the longitudinal axis of the tooth and in contact with the sulcular epithelium. Minimum axial force is used to avoid undue penetration in the tissue. The probe is moved around the crevice gently stretching the epithelium. A bleeding score is given to six gingival areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual regions.
- Secondary outcomeMODIFIED GINGIVAL INDEX visual aspect only; Lobene et al. 1986)
This score will be scored on the pre-experimental phase, baseline and at the final examination (after 4 months)
The gingival condition is assessed using visual signs of inflammation as scored according to the criteria of the Modified Gingival Index on a scale of 0-4 (0=pale pink, 4= reddish blue enlarged) and by bleeding on marginal probing (BOMP), where the gingival margin is probed at an angle of approximately 60 degree to the longitudinal axis of the tooth and the absence or presence of bleeding is scored within 30 seconds of probing on a scale 0-2 (0=non-bleeding, 1= pinprick bleeding, 2=excess bleeding).

PLAQUE (Quigley & Hein, 1962)

This score will be scored on the pre-experimental phase, baseline and at the final examination (after 4 months)

Plaque is assessed after disclosing with Mira-2-Ton® (Hager & Werken GmbH & Co. KG. Duisburg, Germany), using the Turesky (Turesky et al.1970) modification of the index (Quigley & Hein 1962) scored at six sites per tooth as suggested by Lobene et al. (1982) where the absence or presence of plaque is recorded on a scale 0-5 (0=no plaque, 5=plaque covered more than two-thirds of the tooth surface).
- Timepoints-Pre-experimental phase (3 weeks)
-Experimental phase
-baseline
-4 months
- 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 GABA International AG
- Funding
(Source(s) of Monetary or Material Support)
GABA International AG
- PublicationsN/A
- Brief summaryThe study is designed to evaluate the effect of a dentifrice with natural ingredients over a period of 4 months. 90 subjects (non-dental) will be selected on the basis of having moderate gingival inflammation. The single blind study consists of 2 phases: a pre-experimental phase of 3 weeks and an experimental period of 4 months. At the start of the pre-experimental phase gingivitis (MGI) bleeding upon marginal probing (BOMP) and plaque (Quigley & Hein) will be assessed. Subjects receive a written instruction in the use of a manual toothbrush. Furthermore, a combination of Bocasan® and chlorhexidine 0.20% will be used to rinse 2 times per day during the 3 weeks prior to the second fase of the experiment. The baseline assessment is scheduled 3 weeks later. Subjects are randomly assigned to one of 2 groups (test & control). All will be instructed to brush their teeth with their assigned toothpaste for 2 minutes 2 times a day using the timer. Clinical examinations will be performed after 4 months. All parameters assessed at the start of the study are evaluated after 4 months.
- Main changes (audit trail)
- RECORD5-feb-2008 - 13-nov-2008


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