The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is full-mouth peri-implant bleeding score.
Secondary outcome
- Full-mouth periodontal bleeding score;
- Full-mouth peri-implant and periodontal suppuration on probing score (%);
- Full-mouth peri-implant and periodontal probing pocket depth;
- Full-mouth peri-implant and periodontal plaque score (%);
- Marginal soft tissue recession (REC);
- Radiographic marginal peri-implant bone level on standardized intraoral
radiographs;
- Microbiological composition of the peri-implant and periodontal area;
- 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 an infectious disease that resides in the mucosa
surrounding dental implants and also affects the
supporting bone. The number of implants placed in everyday clinical practice is
continuously increasing, and it is
anticipated that the prevalence of peri-implantitis will further increase. This
underlines the necessity for a predictable
therapy. Scientific literature provides very little evidence for an effective
intervention protocol for treatment of periimplantitis.
Study objective
The primary objective of this controlled clinical trial is to evaluate the
clinical effect of systemic amoxicillin plus
metronidazole therapy in conjunction with surgical treatment of
peri-implantitis. The secondary objective is to
assess the microbiological effectiveness of this peri-implantitis treatment
approach.
Study design
The present study is a single-blind, randomized controlled clinical trial.
Intervention
Implants with peri-implantitis (both test and control group) will be surgically
treated (apically repositioned flap, bone recontouring, implant surface
debridement and decontamination). The implant surface will be mechanically
cleaned using plastic curettes and gauzes and cotton pellets soaked in saline.
At the end of the treatment, the dental assistent will give the patients a
bottle with 500 ml 0.12% chlorhexidine + 0.05% cetylpyridinium chloride
mouthrinse without alcohol (Perio-Aid®) (to be used for 2 weeks, twice daily
during 30 seconds) and an envelop containing general aftercare instructions
related to the surgical procedure. The patients in de test group will
additionally receive a recipe for medication consisting of 500 mg amoxicillin
and 500 mg metronidazole to be taken every 8 hours for the following 7 days.
Study burden and risks
All data will be collected during regular treatment and regular follow-up visit
(clinical parameters,
microbiological samples, questionnaires, x-rays, impressions). Since the
regular protocol for treatment of peri-implantitis is evaluated
no additional risks are involved with participation in this study.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
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 peri-implantitis. Peri-implantitis is defined as a loss of marginal bone * 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth * 5 mm;
3) The implants have been in function 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) Uncontrolled diabetes (HbA1c > 7% or > 53 mmol/mol)
5) Mononucleosis infectiosa
6) Organic neurological disorders
7) Use of antibiotics during the last 3 months;
8) Known allergy to amoxicillin, metronidazole or chlorhexidine;
9) Long-term use of anti-inflammatory drugs (> 3 months);
10) Full edentulism (no remaining teeth, only implants)
11) Active periodontal disease at remaining dentition (PPD*6mm, bleeding*20%) and/or insufficient oral hygiene (plaque*20%)
12) Implants placed in areas augmented with autogenous bone from the crista iliac region;
13) Implants placed in skin grafted areas;
14) 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;
15) Implant mobility;
16) Implants at which no position can be identified where proper probing measurements can be performed;
17) Previous surgical treatment of the peri-implantitis lesions;
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-003940-21-NL |
| CCMO | NL46361.042.13 |