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 2% chlorhexidine solution or a placebo. The secondary…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
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;
- Patient satisfaction.
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 peri-implantitis.
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 2% chlorhexidine solution or a placebo.
The secondary objective is to assess the microbiological effect of
decontamination of the implant surface during the surgical treatment of
peri-implantitis using a 2% chlorhexidine solution or a placebo.
Study design
The present study is a double-blind placebo-controlled randomized clinical
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 2 % chlorhexidine solution
or 1 minute of local application of a placebo solution. After 1 minute of
saline rinsing 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 questionnaires have to be filled out and
microbiological samples will be taken. Furthermore digital intra oral pictures
are taken.
Antonius Deusinglaan 1
9713 AV
NL
Antonius Deusinglaan 1
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 peri-implantitis. 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) Diabetes;
5) Systemic use of antibiotics during the last 2 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 remaining dentition;
9) Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 2 months;
10) Bruxism;
11) Implants placed in skin grafted areas;
12) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
13) Implants with bone loss exceding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
14) Implant mobility;
15) Implants at which no postition can be identified where proper probing measurements can be performed;
16) Previous surgical treatment of the peri-implantitis lesions;
17) Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).
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 | NL31262.042.10 |