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van CCT (UK)

Efficacy of a mouthrinse containing Ardox-X Technology on the inhibition of de novo dental plaque formation in vivo.

- candidate number10536
- NTR NumberNTR3145
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-nov-2011
- Secondary IDsNL 37567.018.11 CCMO
- Public TitleEfficacy of a mouthrinse containing Ardox-X Technology on the inhibition of de novo dental plaque formation in vivo.
- Scientific TitleEfficacy of a mouthrinse containing Ardox-X Technology on the inhibition of de novo dental plaque formation in vivo.
- hypothesisThe aim of the study is to evaluate the efficacy of Ardox-X Technology on the inhibition of de novo plaque formation and changes in the microbial composition in periodontally healthy patients in a one-week non-brushing model.
- Healt Condition(s) or Problem(s) studiedDental plaque, Ardox-X Technology
- Inclusion criteria1. ≥ 18 years;
2. Systemically healthy;
3. Minimum of 5 teeth per quadrant;
4. Absence of oral lesions;
5. Not participate in other clinical care study;
6. Overnight plaque assessment of Modified Quigley & Hein index score ≥2;
7. No orthodontic appliances (except for retention lingual wire);
8. No removable (partial) dentures;
9. No prosthetics crowns;
10. No overhanging margins;
11. Signed written-informed consent.
- Exclusion criteria1. The use of antibiotics during the last 6 months;
2. Dutch Periodontal Screening Index (DPSI) ≥3+;
3. Use of medication possibly influencing normal gingival health;
4. Pregnancy;
5. Smoking;
6. The use of electric toothbrush.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-okt-2011
- planned closingdate10-jan-2012
- Target number of participants50
- Interventions This randomized controlled clinical trial takes 9 weeks total. The trial starts with a pre-experimental period of 7 days followed by two experimental weeks. Each experimental week subjects receive a professional dental prophylaxis preformed by dental hygienists. For 2 experimental periods of 7 days, subjects are asked to refrain from brushing and interdental cleaning. Instead of their normal oral hygiene subjects rinse twice daily with a test or control mouthwash. Subjects receive instruction how to use the intervention products and rinse the first time under supervision. According randomization subjects are assigned to the control or test group. In the second experimental week subjects from the control group switch to the test group and vice versa (cross-over design). In the 3 weeks of 'wash-out' period, between the two experimental weeks, subjects resume their normal oral hygiene.
- Primary outcomeModified Quigley & Hein index.
- Secondary outcome1. The Bleeding on marginal probing (BOMP) index;
2. Results from the VAS questionnaire to evaluate the subjects attitude towards the used products;
3. Microbiological analysis to monitor shifts in the composition of the microbiota;
4. QLF.
- TimepointsTime point:
1. Screening;
2. Pre experimental;
3. Experimental;
4. Assesment.
Wash out:
1. Experimental;
2. Assesment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
NGEN, Oral Pharma N.V.
- PublicationsN/A
- Brief summaryMaintaining an adequate low level of plaque through daily toothbrushing is often not feasible. Chemotherapeutic agents as an adjunct to mechanical plaque control would be valuable. Ardox-X Technology has shown to be an effective inhibitor of bacterial growth in-vitro. Up to now in vivo data regarding the anti-microbial effects of Ardox-X Technology mouthrinse are lacking.
- Main changes (audit trail)
- RECORD15-nov-2011 - 17-dec-2011

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