Primary Objective exp. 1:What is the effect of manual toothbrushing after pre-rinsing for 1 minute with water compared with toothbrushing without pre-rinsing on the level of post-brushing dental plaque in healthy subjects?Primary Objective exp. 2:…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Tandplaque
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of dental plaque measured by the modified
Silness & Löe Plaque Index.
Secondary outcome
Questionnaire regarding to oral hygiene and perception of the clinical study.
Assessment of plaque and oral health by use of a novel intra-oral camera.
Background summary
The clinical concepts established in the 1950s remain valid. Namely, that the
maintenance of an effective plaque control is the cornerstone of any attempt to
prevent and control periodontal diseases (Weijden van der & Hioe 2005).
Toothbrushing is today the most widespread mechanical means of controlling
plaque at home (Lang & Karring 1994). The efficacy of brushing with regard to
plaque removal is dictated by three main factors: the design of the brush, the
skill of the individual using the brush and the frequency and duration of use
(Frandsen 1985). Toothbrushing techniques and procedures are thoroughly
investigated to reach high quality of mechanical plaque-control, based on
individual needs, which can efficiently prevent initiation (primary prevention)
as well as recurrence (secondary prevention) of gingivitis and periodontitis.
Supragingival plaque is exposed to saliva and to the natural self-cleansing
mechanisms existing in the oral cavity. However, although such mechanisms may
eliminate food debris, they do not adequately remove dental plaque (Weijden van
der & Hioe 2005). Dawes et al. (1963) described plaque as the soft tenacious
material found on tooth surfaces which is not readily removed by rinsing with
water. However the high-speed camera videos as presented in Kronberg, Germany
showed that pre-wetted plaque might be easier to remove.
Mandibular lingual surfaces demonstrate greater accumulations of both hard and
soft deposits and more bleeding on probing than other areas of the mouth.
Despite these findings, standard toothbrushing focuses little or no attention
on this area. Suggested by Axelsson (Lang & Karring 1994) the toothbrush should
first be applied to the lingual of the mandibular posterior teeth, on the right
side, where most right-handed people do not use the toothbrush efficiently.
Lingual plaque reaccumulates rapidly in this region, and is most adhesive:
toothbrushing should commence there, while most toothpaste is on the brush and
the bristles are most rigid. The mandibular buccal and occlusal surfaces should
then be cleaned (Lang & Karring 1994). Dentists and hygienists have dealt with
this problem by simply telling patients to brush the inside of the bottom teeth
first (O*Hehir 1998).
Study objective
Primary Objective exp. 1:
What is the effect of manual toothbrushing after pre-rinsing for 1 minute with
water compared with toothbrushing without pre-rinsing on the level of
post-brushing dental plaque in healthy subjects?
Primary Objective exp. 2:
What is the effect of manual toothbrushing starting from the lingual aspect of
the lower jaw compared with toothbrushing starting from the buccal aspect of
the upper jaw on the level of post-brushing dental plaque in healthy subjects?
Secondary Objectives:
What is the opinion of the participants of the 48-hours non brushing protocol,
the used toothbrush, the use of a dry/wet toothbrush and rinsing 1 minute of
water?
Additional post-trial objective:
What is the difference between the plaque and gingivitis scores assessed orally
and from an intra-oral photo taken with the SOPROCARE?
Study design
This study is a randomized, single-blind (examiner), two visits, split-mouth
design.
Intervention
Intervention= 1 minute rinsing wil 15ml of Christaline SAINTE-SOPHIE bottled
Spring water
Study burden and risks
Not applicable.
Gustav Maherlaan 3004
Amsterdam 1081 LA
NL
Gustav Maherlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- * 18 years - Classified as systemically healthy, assessed by the medical questionnaire - At least five evaluable teeth in each of the four quadrants excluding teeth with porcelain crowns - Presence of the *Ramfjord teeth* (Ramfjord 1959) or replacement teeth as proposed by Wolf et al (2004) - Regular manual brushers - Right handed (right hand brushers) Participated and/or undergo screening for previous clinical research of the ACTA Department of Periodontology - Willing and able to give written informed consent - Agree to use throughout the study period the distributed products - Agree to brush only manually during the course of the study - Agree not to participate in any other clinical study for the duration of this study - Agree to delay any elective dentistry, including dental prophylaxis (except that provided in this study) until study completion - Agree to refrain from using any other oral care products (f.i. interdental cleaning aids) during the course of the study - Agree to refrain from brushing their teeth and from performing any other oral hygiene procedures for 48 hours prior to each visit.
Exclusion criteria
- Use of medication possibly influencing normal gingival health; use of antibiotics within 2 weeks before the first visit or anticipation of taking antibiotics during the course of the study; chronic use of non-steroidal anti-inflammatory drugs (NSAID*s) - Self-reported pregnancy or nursing
- Anyone presenting a probing depth * 5mm with bleeding on probing and attachment loss * 2 mm (Dutch Periodontal Screening Index (DPSI) * 3+)- Overt caries lesions - Presence of orthodontic banding (except for lingual retention wire), (removable) partial dentures or removable night guard
- Show evidence of any disease or conditions that could be expected to interfere with examination or outcomes of the study.- Dental student or dental professional.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL48620.018.14 |