|- candidate number||8745|
|- NTR Number||NTR2642|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2010|
|- Secondary IDs||NL3356101810 CCMO-METC|
|- Public Title||The effect of a newly developed zendium dentifrice on gingivitis and plaque. Zendium toothpaste. |
|- Scientific Title||The effect of a newly developed zendium dentifrice on gingivitis and plaque. Zendium toothpaste. |
|- hypothesis||The 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) studied||Dental plaque, Gingivitis|
|- Inclusion criteria||1. > 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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-okt-2010|
|- planned closingdate||31-dec-2010|
|- Target number of participants||120|
|- Interventions||Group 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 outcome||1. BOMP (bleeding on marginal probing) - Van der Weijden 1994;|
2. Plaque Index - Quigley & Hein 2007.
|- Secondary outcome||VAS Questionnaire about the used product.|
|- Timepoints||Time point:|
1 visit: BOMP Plaque Index;
2 visit: BOMP Plaque Index;
3 visit: BOMP Plaque Index and VAS.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.A. Weijden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.A. Weijden, van der|
|- Sponsor/Initiator ||ACTA-ADR|
(Source(s) of Monetary or Material Support)
|Sara Lee - Amersfoort|
|- Brief summary||Control 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)|
|- RECORD||7-dec-2010 - 7-nov-2012|