The aim of the study is to test the effectiveness of the Pocketirrigator in patients with generalized advanced periodontitis and to compare this with traditional scaling and rootplaning (SRP).Research questions are:1) is the clinical outcome of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
tandvleesaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
pocketdepth at 6 sites around the teeth measured with a calibrated pocket probe
qualitative microbiological scores
These parameters are recorded before and 3 months after treatment
Secondary outcome
The following other parameters are assessed at the same timepoints also at the
6 sites around the teeth:
- plaque score
- gingival score
- gingival recession towards the cemento-enamel junction in mm
- CAL: clinical atttachment level, counted from the pocketdepth and the
recession
Background summary
Pocketirrigation has been done since many decades with very limited effect (
Greenstein, positionpaper, AAP, 2005). Even when subgingival irrigation was
performed in conjunction with scaling and rootplaning (SRP) the adjunctive
effect of irrigation with or without medicaments was controversial.
The conclusion of the position paper was that there is no evidence that
subgingival irrigation routinely should be used as a supplimental procedure to
augment the effect of SRP.
A new apparatus was designed to irrigate pockets using a small underpressure
enabling the irrigationfluid to reach the depths of the pocket. The apparatus,
callled the Pocketirrigator, consists of a base-station and a handpiece.
Laboratory studies of the Pocketirrigator show fluidcirculations, kind of
wirls, which reach the complete area to irrigate. When fluid is brought in with
a needle, immitating the available tools, only the vicinity of the needle is
irrigated.
In a pilotstudy 6 patients with advanced periodontitis were treated with the
irrigation device on one side where the other side was treated with SRP.
Results of both treatment modalities were similar. A great reduction in plaque,
bleedingtendency and pocketdepth was obtained. Pocketdepth of 7 mm and more
were reduced with 3.5 mm in both the irrigation as well as in the SRP side.
Study objective
The aim of the study is to test the effectiveness of the Pocketirrigator in
patients with generalized advanced periodontitis and to compare this with
traditional scaling and rootplaning (SRP).
Research questions are:
1) is the clinical outcome of irrigation as good ad SRP
2) is 6 times irrigation, twice weekly for 3 weeks sufficient for getting a
clinical relevant result
3) is the microbiological outcome after irrigation different from SRP
4) does irrigation selectively influences the subgingival microflora
Study design
Clinical and microbiological investigation by a periodontist
Initial periodontal treatment by a dental hygienist in 3 consecutive weeks
Clinical and microbiological evaluation after 3 months by the same periodontist
The initial treatment consist of:
- oral hygiene instructions
- supragingival cleaning
- subgingival cleaning by instruments or
- subgingival cleaning with the Pocketirrigator on the contralateral side
- a 2nd irrigation on the irrigation side in the same week
It is decided by flip of the coin by the dental hygienist which side is
irrigated with the Periosonic.
Periodontists/ examinors do not know which side is irrigated.
Supragingival cleaning is done 4 weeks before the evaluation in order to make
it impossible for the examinor to see which side is irrigated.
Microbiological samples are taken before treatment, in the third week of
treatment, just after the subgingival cleaning and 4 weeks before the
evaluation.
Intervention
Patients with a advanced periodontitis, who are selected for this study are
treated on a normal standardized way.
The first phase of the treatment consists of oral hygiene instructions and
supra- and subgingival cleaning.
In this study it is tested whether the subgingival cleaning which normally is
done with curettes can be replaced by pocketirrigation.
Study burden and risks
Treatment as done in this study is the standard treatment for periodontal
diseases, except for the irrigation which is done on one side of the jaw.
Irrigation is done with the Pocketirrogator, is not invasive and takes place
under a very small negative pressure. Irrigation is done with water, is
painless and not unpleasant in contrast with the standard cleaning with SRP
which needs often local anaesthesia.
Since irrigation is not invasive it is beleaved that bacteriemia which takes
place with SRP will not occur.
Irrigation is done twice weekly for 3 weeks, whereas the SRP needs only one
session per week. On the other side, one pocketirrigation takes only 5-10
minutes for a whole mouth whereas SRP needs more than 2 hours.
Stationsweg 6
9951BA Winsum
NL
Stationsweg 6
9951BA Winsum
NL
Listed location countries
Age
Inclusion criteria
patients with generalized advanced periodontitis
Exclusion criteria
no systemdisorders; pregnant;no antibioticum use since 3 months;no partial dentures;no previous periodontal treatment
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 | NL31743.042.10 |