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van CCT (UK)

van CCT (UK)

The effect of a newly developed zendium dentifrice on gingivitis and plaque. Zendium toothpaste.

- candidate number8745
- NTR NumberNTR2642
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-dec-2010
- Secondary IDsNL3356101810 CCMO-METC
- Public TitleThe effect of a newly developed zendium dentifrice on gingivitis and plaque. Zendium toothpaste.
- Scientific TitleThe effect of a newly developed zendium dentifrice on gingivitis and plaque. Zendium toothpaste.
- hypothesisThe primary objective of the present trial is to evaluate, during a 4-week period, the efficacy of a Zendium dentifrice containing enzymes, colostrum, lysozyme & zinc, in combination with the use of a manual toothbrush with respect to plaque removing efficacy, plaque growth inhibition, and effect on gingival inflammation.
- Healt Condition(s) or Problem(s) studiedDental plaque, Gingivitis
- Inclusion criteria1. > 18 years;
2. Systemically healthy;
3. Minimum 5 teeth per quadrant;
4. Moderate gingivtis (40% bleeding on marginal probing);
5. Not participate in other oral clinical care study;
6. An absence of oral lesions and/or periodontal pockets ≤ 5 mm.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2010
- planned closingdate31-dec-2010
- Target number of participants120
- InterventionsGroup 1: Experimental zendium dentifrice based on mild enzym complex non-SLS zendium;
Group 2: Regular zendium non SLS;
Group 3: Colgate SLS dentifrice;
Group 4: Sensodyne SLS dentifrice.

The intervention will have a duration of 4 weeks in which the participants have 2 visits.
- Primary outcome1. BOMP (bleeding on marginal probing) - Van der Weijden 1994;
2. Plaque Index - Quigley & Hein 2007.
- Secondary outcomeVAS Questionnaire about the used product.
- TimepointsTime point:
1 visit: BOMP Plaque Index;
2 visit: BOMP Plaque Index;
3 visit: BOMP Plaque Index and VAS.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA-ADR
- Funding
(Source(s) of Monetary or Material Support)
Sara Lee - Amersfoort
- PublicationsN/A
- Brief summaryControl of plaque on the tooth surfaces is the most important method of controlling dental disease. A manual toothbrush is the most popular mechanical method of plaque control. This non-specific control of the periodontal microbiota is effective in the majority of cases where access to the plaque deposits is possible (Listgarten 1988). In spite of the activity in improving toothbrush type and design, most people reduce plaque scores only with approximately 50% when they brush their teeth (Jepsen 1998). The development of a dentifrice that would allow the average person in helping to control plaque and gingivitis would be desirable.
- Main changes (audit trail)
- RECORD7-dec-2010 - 7-nov-2012

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