Antibiotics as adjunct to surgical treatment of dental implant infections
- Conditions
- peri-implantitisTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2013-003940-21-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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;
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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main 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;Secondary Objective: The secondary objective is to assess the microbiological effectiveness of the peri-implantitis treatment approach under investigation in this trial.;Primary end point(s): absence of bleeding and/or suppuration on peri-implant probing;Timepoint(s) of evaluation of this end point: 3 and 12 months after active treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Full-mouth periodontal bleeding score (%); <br>2) Full-mouth periodontal suppuration on probing score (%);<br>3) Full-mouth peri-implant and periodontal probing pocket depth; <br>4) Full-mouth peri-implant and periodontal plaque score (%); <br>5) Marginal soft tissue recession (REC); <br>6) Radiographic marginal peri-implant bone level on standardized intraoral radiographs; <br>7) Microbiological composition of the peri-implant and periodontal area; <br>8) 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; <br>9) Complications and adverse events.;Timepoint(s) of evaluation of this end point: 3 and 12 months after active treatment