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
Bron
Verkorte titel
Aandoening
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?
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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?
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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?
Onderzoeksopzet
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)
Onderzoeksproduct en/of interventie
Group 1: Philips Sonicare AirFloss Ultra plus Listerine Cool Mint
Group 2: Waxed dental floss, Brand: Johnson & Johnson, Type: Ultraclean®
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4866 |
| NTR-old | NTR4983 |
| CCMO | NL51667.018.14 |
| OMON | NL-OMON42140 |