Objective: The objective of the study is to evaluate the long-term effect of a short preventive intervention on oral health.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters: Bleeding on Marginal Probing- Index.
Secondary outcome
Secondary parameters: Plaque Index and Staining-Index.
Background summary
Backround: It is generally accepted that bacterial plaque is an important
etiological factor of periodontal disease. Mechanical plaque removal is the
primary method for controlling supra-gingival plaque. Patients' efforts are
however often compromised by the presence of hard-to-reach areas as well as
inadequate skill, poor motivation and lack of compliance. Consequently above
the age of 35 almost everybody has inflamed periodontal tissues. Antimicrobial
mouthrinses as adjuncts to mechanical oral hygiene regimens have been
introduced as a means to enhance plaque removal. In 2 recent studies a
stringent protocol of 1 oral hygiene instruction,1 session of professional and
3 weeks of rinsing with chlorhexidine and sodiumperoxyborate significantly
improved the level of gingival health which was maintained up to a subsequent
period of 9 months. The design of the present study is based on a model as
previously published by Svatun et al. (Svatun et al. 1987, Svatun et al. 1989)
and will test the concept that good gingival health can be maintained by the
use of a prophylactic aid.
Study objective
Objective: The objective of the study is to evaluate the long-term effect of a
short preventive intervention on oral health.
Study design
Study design: 240 subjects will be divided *at random* among 6 groups. All 6
groups will perform a basic regime of 2x daily brushing with a standard
toothbrush and toothpaste. Group 1 and 2 will brush only, group 3 will receive
additionally 1 oral hygiene instruction, group 4 will receive 1 professional
prophylaxis, group 5 will rinse for 3 weeks with chlorhexidine and
sodiumperoxyborate and group 6 will receive all 3 supplementary preventive
interventions. Group 1 will be seen at baseline 3 weeks and 12 months while the
other 5 groups will be seen at baseline, 3 weeks, 3, 6, 9 and 12 months.
Intervention
A basic regime of 2x daily brushing with a standard toothbrush and toothpaste.
- with no additional regimen OR
- with additionally 1 oral hygiene instruction OR
- with additional 1 professional prophylaxis OR
- with additional rinsing for 3 weeks with chlorhexidine and sodiumperoxyborate
OR
- with additional a combination of 1 oral hygiene instruction, 1 professional
prophylaxis and for 3 weeks rinsing with chlorhexidine and sodiumperoxyborate
Study burden and risks
n/a
Louwesweg 1
1066 EA Amsterdam
NL
Louwesweg 1
1066 EA Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-*18 years of age, -a minimum of 5 evaluable teeth in each quadrant (with no partial dentures, orthodontic banding or wires) * 40% bleeding on marginal probing.
Exclusion criteria
-oral lesions and/or periodontal pockets >5 mm - pregnancy or systemic diseases such as diabetes
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 | NL28783.018.09 |