The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surfaceduring the surgical treatment of peri-implantitis using a 35% phosphoric acid gel or saline.The secondary objective…
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The primary study parameter is the modified bleeding index.
Secondary outcome
Secundary study parameters are:
- Microbial composition of the biofilm covering the dental implant surface;
- Microbiological composition of the peri-implant sulcus;
- Probing pocket depth;
- Suppuration on probing;
- Radiographic marginal bone level on standardized intraoral radiographs;
- Modified plaque index;
- Implant calculus index;
- Marginal soft tissue recession (REC);
- Implant failure, defined as implant mobility of previously clinically
osseointegrated implants and removal of non-mobile implants because of
progressive marginal bone loss or infection;
- Complications and adverse events;
Background summary
Peri-implantitis is a infectious disease that resides in the mucosa surrounding
dental implants and also affects the supporting
bone. Because the number of implants placed in everyday clinical practice is
continuously increasing, is it reasonable to
anticipate an increasing prevalence of peri-implantitis. This underlines the
necessity for a predictable therapy. However, from
the literature there is very little reliable evidence suggesting which could be
the most effective interventions for treating periimplantitis.
A recent randomized controlled trial (METc NL.27147.042.09, as of yet
unpublished data) showed that rinsing the implant surface during resective
surgical peri-implantitis therapy with 0.12% CHX + 0.05% CPC leads to a
superior elimination of anaerobic bacterial from the implant surface compared
to rinsing with a placebo solution. However, no superior clinical results were
observed. An ongoing study comparing a 2% CHX-solution with a 0.12% CHX -
solution for implant surface decontamination, indicates that increasing the
concentration of CHX does not significantly improve microbiological results
(METc NL.31262.042.10). From both studies it may be concluded that the
effectiveness of implant surface decontamination with CHX- containing products
is limited. It may therefore be advisable to focus on other antiseptics. One
such potentially beneficial antiseptic is 35% phosphoric etching gel.
Study objective
The primary objective of this controlled clinical study is to evaluate the
clinical effect of decontamination of the implant surface
during the surgical treatment of peri-implantitis using a 35% phosphoric acid
gel or saline.
The secondary objective is to assess the microbiological effect of
decontamination of the implant surface during the surgical
treatment of peri-implantitis using a 35% phosphoric acid gel or saline.
Study design
The present study is a single-blind, randomized controlled trial
Intervention
Implants with peri-implantitis lesions will be surgically exposed, followed by
a mechanical cleansing using curettes and gauzes
and cotton pellets soaked in saline and either 1 minute of local application of
a 35% phosphoric acid gel or 1 minute of local
application of saline. After 1 minute of saline rinsing (both groups) the
gingival flap will be returned slightly apical (in order to
reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks
of rinsing with 0.12% chlorhexidine + 0.05%
cetylpyridinium chloride without alcohol twice daily during 30 seconds.
Study burden and risks
In addition to the regular follow-up visits (after 2 weeks, 3 and 6 months)
patients will have one additional appointment for
research purpuses only. During the appointments microbiological samples will be
taken and digital intra oral pictures will be taken.
Antonius Deusinglaan 1 FB 21
Groningen 9713 AV
NL
Antonius Deusinglaan 1 FB 21
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
1) The patient is >= 18 years of age;
2) The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of periimplantitis. Peri-implantitis is defined as a loss of marginal bone >= 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth >= 5 mm;
3) The implants have been exposed to the oral environment for at least two years;
4) The patient is capable of understanding and giving informed consent.
Exclusion criteria
1) Medical and general contraindications for the surgical procedures;
2) A history of local radiotherapy to the head and neck region;
3) Pregnancy and lactation;
4) Insuline-dependent diabetes;
5) Systemic use of antibiotics during the last 3 months;
6) Long-term use of anti-inflammatory drugs;
7) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
8) Active, uncontrolled periodontal pathology of the natural dentition (PPD > 5mm);
9) Implants placed in skin grafted areas;
10) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
11) Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
12) Implant mobility;
13) Implants at which no position can be identified where proper probing measurements can be performed;
14) Previous surgical treatment of the peri-implantitis lesions;
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 | NL42191.042.12 |