What is the effect of Philips Airfloss Ultra plus Listerine Cool Mint compared to dental floss after a healing of experimental induced gingivitis as evaluated with the Bleeding on Marginal Probing (BOMP) index in a group of systemically healthy…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of Bleeding On Marginal Probing (BOMP)
(Van der Weijden et al. 1994).
Secondary outcome
The secundary outcome is (clinical):
- Level of gingival abrasion ; Gingival Abrasion Score (Van der Weijden et al.
2004).
- Subjects* attitude towards the study products
The secundary outcome is (laboratory):
* Microbial ecology of interdental plaque
* Microbial ecology of tongue dorsum
* Total Candida counts in unstimulated saliva, interdental plaque and tongue
dorsum
* Total bacterial counts in saliva, interdental plaque and tongue dorsum?
Background summary
Oral cleanliness is important for the preservation of oral health as it removes
microbial plaque, preventing it from accumulating on teeth and gingivae.
Currently, the use of a toothbrush and fluoridated toothpaste in developed
countries is almost universal. The efficacy in plaque removal on average
following a single brushing exercise is only a reduction from baseline plaque
scores of 42%.
The interdental space is a sheltered area that is difficult to access when
teeth are in their normal positions. Tooth brushing alone does not reach the
interproximal areas of teeth, resulting in parts of the teeth that remain
unclean. Removal of plaque from these surfaces remains a valid objective
because, in patients susceptible to periodontal disease, gingivitis and
periodontitis are usually more pronounced in this interdental area than on oral
or facial aspects. Good interdental oral hygiene requires a device that can
penetrate between adjacent teeth.
The oral irrigator has been on the market for decades and research has shown
that I effective in reducing the level of gingivitis. The combination with an
antimicrobial mouth rinse has been research but also abandoned. This because
the cost-effectiveness is not favourable. The new airfloss combines the
principles of the oral irrigator with a small amount of water flow. So far
research has focused on the use of water with this device. In the present study
it will be combined with an anti-microbial fluid to enhance its effect.
Study objective
What is the effect of Philips Airfloss Ultra plus Listerine Cool Mint compared
to dental floss after a healing of experimental induced gingivitis as evaluated
with the Bleeding on Marginal Probing (BOMP) index in a group of systemically
healthy participants without periodontitis?
Secondary Objectives- clinical:
- What is the effect of Philips Airfloss Ultra plus Listerine Cool Mint
compared to dental floss on the level of dental plaque scores in a group of
systemically healthy volunteers?
- What is the effect of Philips Airfloss Ultra plus Listerine Cool Mint
compared to dental floss on the approximal gingival abrasion scores in a group
of systemically healthy volunteers?
- What is the perception of the participants attitudes towards the two
interdental devices used in this study?
Secondary Objectives- laboratory:
- What are the effects of Philips Sonicare AirFloss Ultra plus Listerine Cool
Mint on interdental plaque composition?
- What are the effects of Philips Sonicare AirFloss Ultra plus Listerine Cool
Mint on microbial composition of tongue dorsum?
- What are the effects of Philips Sonicare AirFloss Ultra plus Listerine Cool
Mint on microbial composition of saliva?
- What are the effects of Philips Sonicare AirFloss Ultra plus Listerine Cool
Mint on Candida counts in saliva, interdental plaque and tongue dorsum?
- What are the effects of Philips Sonicare AirFloss Ultra plus Listerine Cool
Mint on total bacterial counts in saliva, interdental plaque and tongue dorsum?
Third Objectives:
- What is the effect of introducing interdental cleaning in a group that has
not done so before on bleeding scores and microbiome?
- What is the influence papilla height relative to the crown length of the
front teeth in relation to efficacy of the interdental devices?
Study design
This study is a parallel, single-blind (examiner), randomly assigned
intervention design evaluating the healing of experimentally induced
gingivitis.
Intervention
Philips Airfloss Ultra plus Listerine Cool Mint
Study burden and risks
Neither immediate nor long-range physical risks are involved. Minimal physical
risks are listed below:
During the 3 weeks non brushing period in the lower jaw, gingival inflammation
develops. Gingivitis can occur to the gingiva of the gums a pain sensation,
swelling, redness and bleeding. By screening only these subjects which can
develop a reversible gingivitis are selected for participating in this study
and therefore the long term risk is negligible.
The results of this research cannot be foreseen, so it is possible that adverse
events may arise in the study. The investigator or designee is responsible for
the detection and documentation of (serious) adverse events (S)AE*s as
described in the following sections.
Gustav Marhlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Marhlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- Male and female
- Right handed brusher and writer
- Age 18-35 years
- Classified as systemically healthy, assessed by medical questionnaire
- Minimum of 20 natural teeth: at least 5 evaluable in each quadrant of the lower jaw available
- DPSI 0-3 minus
- a screening for bleeding on marginal probing *25%
- Dental floss should fit interdentally in at least three interdental spaces per quadrant in the lower jaw, excluding the interdental central incisors space. Of these three spaces, at least two spaces should involve of the molar area.
- Willing and able to give written informed consent
- Agree to follow the study instructions for the duration of the study
- Agree to refrain from brushing the lower jaw for 21 days in the experimental phase
Exclusion criteria
- Overt dental caries
- Usage of any interdental device as part of regular daily oral care (>1 time a week)
- Smokers (Lie et al. 1998, definition non-smoker: <1 cigarette every day for at least one year)
- Removable (partial) dentures
- Crowns, bridges and implant supported restorations
- Overhanging restorations in the lower jaw as assessed with a periodontal probe
- Removable night guard
- Oral and/or peri-oral piercings
- Apparent oral lesions
- Presence of orthodontic banding (except for lingual retention wire)
- Oral surgery within the last 2 months
- Dental student or dental professional
- Participation in a clinical study within the previous 30 days ;General health and use of medication:
- Self-reported pregnancy or breastfeeding
- Use of antibiotics during the last 3 months
- Need of antibiotic prophylaxis prior to dental treatment
- Use of anti-inflammatory drugs on a regular basis
- Show evidence of any (systemic) disease or condition that could be expected to interfere with examination or outcomes of the study
- Adverse medical history or long-term medication
- Prescribed medication (except for anti-contraceptives birth control pills)
- A cardiac pacemaker or implanted cardiac defibrillator
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 | NL51667.018.14 |
| OMON | NL-OMON29183 |