peri-implantitis
Conditions
Interventions
Trade Name: Amoxicillin
Pharmaceutical Form: Tablet
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Tr
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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; 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Full-mouth periodontal bleeding score (%); 2) Full-mouth periodontal suppuration on probing score (%); 3) Full-mouth peri-implant and periodontal probing pocket depth; 4) Full-mouth peri-implant and periodontal plaque score (%); 5) Marginal soft tissue recession (REC); 6) Radiographic marginal peri-implant bone level on standardized intraoral radiographs; 7) Microbiological composition of the peri-implant and periodontal area; 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; 9) Complications and adverse events.;Timepoint(s) of evaluation of this end point: 3 and 12 months after active treatment | — |
Countries
Netherlands
Contacts
Public ContactY.C.M. de Waal
University Medical Center Groningen
Outcome results
None listed