Primary objective: - What is the effect of the commercially available Water Flosser compared to interdental brushes evaluating gingival bleeding in a group of systemically healthy participants with gingivitis but without periodontitis?Secundary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Gingival bleeding and gingival abrasion
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of Bleeding upon Pocket Probing (BOPP).
Secondary outcome
The secundary outcome is:
- Bleedingscores assessed with the Bleeding On Marginal Probing (BOMP)
- Abrasion scores assessed with the Modified gingival abrasion index
- Subjects'attidue towards the study protocol and study products according to
the VAS
- Clinical photos taken of the buccal aspect of teeth from cuspid to cuspid
Background summary
The most common method to prevent caries and periodontal diseases is mechanical
supragingival plaque control by toothbrush. For most people however, total
plaque removal seems not a realistic goal (De la Rosa et al. 1979). There is
strong evidence that the overall treatment effect of a manual brushing
exercise, estimated as a weighted mean difference between pre and post
brushing, showed a plaque score reduction of 42%.
The toothbrush does not adequately reach the interproximal surfaces of the
teeth (De la Rosa et al. 1979). As gingivitis and periodontitis are usually
more pronounced in the interdental areas than on the oral or facial surfaces in
susceptible patients, the removal of plaque from these surfaces is very
important (Loe 1979). Therefore various adjuncts to plaque control have been
developed such as dental floss, toothpicks and interdental brushes. with the
intention to augment the effect of tooth brushing on reducing interdental
plaque (Warren & Charter 1996).
Moderate evidence was available for the efficacy of interdental brushes in
addition to tooth brushing as compared with tooth brushing alone. There also
emerged weak evidence that the oral irrigator plus tooth brushing compared to
regular oral hygiene has an effect on gingivitis. The magnitude remained
unclear and it also lacked evidence on a concomitant reduction of plaque
scores. At present there are no clinical trails trials in which the oral
irrigator has not been directly compared to interdental brushes.
Study objective
Primary objective:
- What is the effect of the commercially available Water Flosser compared to
interdental brushes evaluating gingival bleeding in a group of systemically
healthy participants with gingivitis but without periodontitis?
Secundary objective:
1. What is the effect of the commercially available Water Flosser compared to
interdental brushes evaluating gingival interdental abrasions in a group of
systemically healthy participants with gingivitis but without periodontitis?
2. What is the papilla height relative to the crown length in a group of
systemically healthy participants with gingivitis but without periodontitis?
3. What is the perception of the participants attitudes towards the two
interdental devices used in this study?
Study design
This is a parallel, single-blind (examiner) randomly assigned intervention
design with 2-group, during 30-days trial
Intervention
Test group: Waterpik® with a classic standard jet tip (with water) + manual
toothbrush
Control group: Interdental brush Tepe + manual toothbrush
Both groups will use the same commercially available dentrifrice.
Study burden and risks
Neither immediate nor long-range physical risks are involved.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- Male and female
- Age 18-65 years
- Right handed brusher and writer
- Classified as systemically healthy
- Non-smokers (Lie et al. 1998) definition non-smoker: <1 cigarette every day for at least one year
- Moderate gingivitis (level of gingival bleeding assessed BOPP *50%)
- Minimum of 20 natural teeth, at least 5 evaluable in each quadrant available
- Buccal accessible interdental spaces to apply the interdental brush
- The interdental brushes must fit between at least 4 spaces per quadrant when approached buccally, of these 2 should be interdental spaces involving at least two spaces of the molar area.
- The other 2 spaces can be between the pre-molars, cuspid and incisors.;The participant is willing during the study:
- able to give written informed consent
- to brush with a manual toothbrush for the duration of the study
- to brush between 2 and 3 hours prior to clinical measurements in the screening-, experimental- and treatment phases
- refrain from rinsing with an antiseptic mouthwash during the study
- refrain from using any other interdental devices during the study
- refrain from excessive gum use (using >3 chewing gums daily) during the study
Exclusion criteria
- Pockets deeper than 5mm (excluding distal of the last molars)
- Overt dental caries
- Oral lesions
- Usage of any interdental device as part of regular daily oral care
- Removable (partial) dentures
- Crowns, bridges and implant supported restorations
- Removable night guard
- Orthodontic banding (except for lingual retention wire)
- Oral and/or peri-oral piercings
- Dental student or dental professional
- Participation in a clinical study within the previous 30 days ;General health:
- Medication, except for birth control pills
- 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
- Evidence of any systemic disease or compromised health condition
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 | NL58265.018.16 |
| OMON | NL-OMON24237 |