search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effect of maltitol sweetened chewing gum on the oral microbiology -RCT-


- candidate number15389
- NTR NumberNTR4165
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2013
- Secondary IDsNL45518.018.13 CCMO
- Public TitleThe effect of maltitol sweetened chewing gum on the oral microbiology -RCT-
- Scientific TitleThe effect of maltitol sweetened chewing gum on the oral microbiology -RCT-
- ACRONYMBart Keijser Roquette (BAKER)
- hypothesisWhat is the effect of the use of a maltitol sweetened chewing gum compared to a gum base and no gum in during a 28 days on the composition of the supragingival plaque microbiome in healthy non dental students ≥ 18 years old.
- Healt Condition(s) or Problem(s) studiedCaries, Gingivitis
- Inclusion criteria1. Male and female Students age ≥18 years ( upper limit 45 years old)
2. Classified as systemically healthy, assessed by medical questionnaire
3. Non-smokers (Lie et al. 1998) definition non-smoker: <1 cigarette every day for at least one year
4. Minimum of 20 natural teeth: at least 5 evaluable teeth in each quadrant DPSI 0-3-
5. With moderate gingivitis (30-60% BOMP ) (Keukenmeester et al.2013 submitted).
6. No partial dentures
7. No orthodontic banding
8. No oral lesions Subjects who do not use an interdental cleaning device at home.
- Exclusion criteria1. Anyone presenting with a probing depth ¡İ5mm with bleeding on probing and attachment loss ≥ 2 mm
2. Overt dental caries
3.Usage of any interdental device as part of regular daily oral care Smokers DPSI ≥3+-4 (appendix 13.4)
4. Removable (partial) dentures Crowns, bridges and implant supported restorations
5. Removable night guard
6. Oral and/or peri-oral piercings
7. Apparent oral lesions (aphthous ulcers excluded)
8. Presence of orthodontic banding (except for lingual retention wire)
9. Dental student or dental professional
10. Participation in a clinical study within the previous 30 days
11. A big chewing-gum consumer > 3 gums a day

General health and use of medication:
1. Self-reported pregnancy or breastfeeding
2. Use of antibiotics during the last 2 months
3. Need of antibiotic prophylaxis prior to dental treatment Use of anti-inflammatory drugs on a regular basis Evidence of any systemic disease or compromised health condition
4. Adverse medical history or long-term medication Prescribed medication (except for anti-contraceptives - birth control pills)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-sep-2013
- planned closingdate5-dec-2013
- Target number of participants160
- InterventionsIntervention: maltitol sweetened chewing gum Placebo: gum base Control: no gum
- Primary outcome2 Supragingivale tandplaque samples
- Secondary outcome1. Gingivitis
2. Caries
3. Gingival biotype
4. Food Frequency Questionnaire
- TimepointsScreening
Visit 1: baseline
Visit 2: day 28
Visit 3: day 42
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.A. Weijden, van der
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA-ADR
- Funding
(Source(s) of Monetary or Material Support)
TNO
- PublicationsN/A
- Brief summaryThis metgenomic study is based on the Marsh¡¯s theory ( Marsh et al 2006, BMC oral health). This theory consist in considering that the bacteria of dental plaque belong to a dynamic equilibrium where various factors can be deleterious. Indeed environment( diet health status) can let or not some pathogenic bacteria colonizing dental plaque. The equilibrium can move form a ¡¯¡¯healthy state¡¯¡¯ to a ¡¯¡¯sick state¡¯¡¯. Sugar alcohols, a class of polyols, are commonly added to foods because of their lower calorific content compared to sugars. Maltitol, sorbitol, xylitol, erythritol are often used as sweetner in chewing gum because they are not broken down by bacteria in the mouth or metabolized to acids, and thus do not contribute to tooth decay. Importantly, polyol sugars promote tooth mineralization by increasing the flow of saliva. Xylitol and sorbitol have been demonstrated in vivo and in vitro to inhibit growth of a number of cariogenic bacterial species, including mutans streptococci, most prominently Streptococcus mutans and Streptococcus sobrinus. The exact mechanism of action of xylitol on mutans streptococci (MS) is not fully known but habitual xylitol consumption, at high enough doses reduces counts of MS, apparently making plaque and mutans streptococci less adhesive to teeth. Loesche et al showed that consumption of 5−7 g of xylitol in chewing gum reduced MS in both plaque and saliva but not counts of S. sanguis. Very little is actually known about the effects of the polyole sugars on the oral microbiota. This study aims to establish the effects of frequent consumption of chewing gum (sweetened with maltitol or the use of gum base) during 28 days on the oral microbiome composition, and to relate to effects to microbial risk factors for gingivitis and caries. Also, the prolonged effects of chewing gum (sweetened with maltitol or the use of gum base) consumtion are examined after 2 weeks. The study can contribute to effective dosage of gum consumption and improve our understanding on the level of the dental plaque ecosystem.
- Main changes (audit trail)
- RECORD10-sep-2013 - 29-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl