The 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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Tandplakvorming
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome variable is the Modified Quigley & Hein index
Secondary outcome
Secondary outcome variable is:
• The Bleeding on marginal probing (BOMP) index.
• Results from the VAS questionnaire to evaluate the subject*s attitude towards
the used products.
• Microbiological analysis to monitor shifts in the composition of the
microbiota
Background summary
Maintaining 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.
Study objective
The 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.
Study design
A randomized double blind controlled clinical trial will be performed in a
cross-over design, consisting of three phases: a pre-experimental phase, two
experimental phases of one week (Ardox-X® Technology and its control,
respectively) (with 3 weeks of washout in between).
Intervention
One week of no mechanical oral hygiene but rinsing twice daily for one minute.
Study burden and risks
The risks for the subjects are minimal because it concerns a product that is
already on the market in The Netherlands for many years. According to the
manufacturer all ingredients are used in other products current in the market
applied on the oral environment. So far no side effects have been reported.
Moreover ceasing toothbrushing for a period of seven days does not have a
significant negative influence on the subject. It is an accepted research model
for studies on the effect of mouthrinses (e.g. Chadha et al., 1978, Wennström,
1998, Quirynen et al., 2001).
Gustav Mahlerlaan 3004
1081 LA
NL
Gustav Mahlerlaan 3004
1081 LA
NL
Listed location countries
Age
Inclusion criteria
• >= 18 years • Systemically healthy • minimum of 5 teeth per quadrant • absence of oral lesions • not participate in other clinical care study • Overnight plaque assessment of Modified Quigley & Hein index score >=2 • No orthodontic appliances (except for retention lingual wire) • No removable (partial) dentures • No prosthetics crowns • No overhanging margins • Signed written-informed consent
Exclusion criteria
• The use of antibiotics during the last 6 months • Dutch Periodontal Screening Index (DPSI) >=3+ • Use of medication possibly influencing normal gingival health • Pregnancy • Smoking • The use of electric toothbrush
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37567.018.11 |
| OMON | NL-OMON25700 |