Surgical treatment of peri-implantitis with and without systemically adjunctive antibiotics
- Conditions
- peri-implantitisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-004724-11-SE
- Lead Sponsor
- Karolinska Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 66
1.Male or female =18 year
2.Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
3.Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for = one year
4.Peri-implantitis is diagnosed when; PPD of = 6mm can be found at a dental implant in association with BOP and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least = 3 fixture threads).
5.Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
6.Full-Mouth Plaque Score (FMPS) = 30
7.Signed 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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
1.Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactam.
2.Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8–9 %, 64–75 mmol/mol), I.V bisphosphonate treatment due to malignancy, pregnant and lactating women).
3.Incapability to perform basal oral hygiene measures due to physical or mental disorders.
4.Received systemic antimicrobial therapy in the past three months.
5.Currently on allopurinol, digoxin, disulfirom, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfrin.
6.Known severe chronic peripheral or central disease of the nervous system
7.Known alcohol abuse
8.Known hepatic encephalopathy
9.Known lactose intolerance, galactose intolerance
10.Untreated periodontal condition.
11.Implant showing sign of mobility.
12.Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants.
13.Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize patient safety
Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.
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 the present study is to evaluate the adjunctive effect of systemically administered antibiotics during surgical treatment of peri-implantitis.;Primary end point(s): Peri-implant pocket depth reduction/Probing pocket depth (PPD) reduction;Timepoint(s) of evaluation of this end point: baseline, 6 months and 12 month;Secondary Objective: 1. Evaluate changes in the clinical and radiographic outcome after surgical intervention of peri-implantitis.<br>2. Assess the development of antibiotic resistance in the oral and intestinal microflora after treatment with systemically administered antibiotics.<br>3. Compare quantitative and qualitative changes in the oral and intestinal microflora after two different combinations of antibiotic treatment (penicillin-V+metronidazol versus amoxicillin+metronidazol). <br>4. Determine antibiotic concentration in saliva and feces.<br>5. Evaluate the safety of antimicrobial treatment.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Marginal bone level stability measured directly postoperative and 12 month after treatment<br>2. Reduction of clinical soft tissue inflammation, bleeding on probing (BOP).<br>3. Soft tissue recession (REC) and clinical attachment level gain (CAL)<br>4. Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora <br>5. Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin. <br>6. Quantitative and qualitative changes in the oral and intestinal microflora.<br>7. Concentration of amoxicillin, metronidazole and PcV in saliva and feces.<br>8. Follow-up of adverse events related or unrelated to the investigated medical products<br>;Timepoint(s) of evaluation of this end point: Measured directly postoperative and 12 month after surgery