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The effect of Philips Airfloss Ultra plus Listerine compared to dental floss on gingival bleeding, dental plaque, and gingival abrasion in a healing of experimental gingivitis model, a parallel design


- candidate number21627
- NTR NumberNTR4983
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2015
- Secondary IDsNL51667.018.14 
- Public TitleThe effect of Philips Airfloss Ultra plus Listerine compared to dental floss on gingival bleeding, dental plaque, and gingival abrasion in a healing of experimental gingivitis model, a parallel design
- Scientific TitleThe effect of Philips Airfloss Ultra plus Listerine compared to dental floss on gingival bleeding, dental plaque, and gingival abrasion in a healing of experimental gingivitis model, a parallel design
- ACRONYMAPPLE: Airfloss Ultra plus Listerine Evaluated
- hypothesisWhat 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?
- Healt Condition(s) or Problem(s) studiedDental plaque, Gingival bleeding, Flossing
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-feb-2015
- planned closingdate30-apr-2015
- Target number of participants80
- InterventionsGroup 1: Philips Sonicare AirFloss Ultra plus Listerine Cool Mint

Group 2: Waxed dental floss, Brand: Johnson & Johnson, Type: UltracleanŽ
- Primary outcomeWhat 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 outcomeClinial:
 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?
- TimepointsScreening
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)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.A. Weijden, van der
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA Dental Research BV
- Funding
(Source(s) of Monetary or Material Support)
Philips
- PublicationsNA
- Brief summaryOral 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.
- Main changes (audit trail)
- RECORD29-jan-2015 - 21-mrt-2015


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