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ID
Source
Brief title
Health condition
The main study parameter is the level of Bleeding On Marginal Probing (BOMP) (Van der Weijden et al. 1994)
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?
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the effect of Philips Sonicare 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 outcome
Clinial:
What is the effect of Philips Sonicare AirFloss Ultra PRO 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 Sonicare AirFloss Ultra PRO 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?
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 PRO plus Listerine Cool Mint on microbial composition of saliva?
What are the effects of Philips Sonicare AirFloss Ultra PRO 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?
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?
Study design
Screening
1. Familiarization phase
2. Experimental gingivitis phase (day 0)
3. Treatment phase (day 21, week 3)
4. Treatment phase (week 4)
5. Treatment phase (week 5)
6. Treatment phase (week 7)
Intervention
Group 1: Philips Sonicare AirFloss Ultra plus Listerine Cool Mint
Group 2: Waxed dental floss, Brand: Johnson & Johnson, Type: Ultraclean®
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
Afdeling CPT- Parodontologie<br>
Gustav Mahlerlaan 3004
G.A. Weijden, van der
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5188307
ga.vd.weijden@acta.nl
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
Dutch Periodontal Screening Index (DPSI) 0-3- (appendix 14.3) of the periodontium
≥25% BOMP bleeding on marginal probing in the lower jaw at the moment of clinical screening
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 molar areas.
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 (>1 time a week) any interdental device as part of regular daily oral care
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 in the lower jaw
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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4866 |
| NTR-old | NTR4983 |
| CCMO | NL51667.018.14 |
| OMON | NL-OMON42140 |