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Clinical Trials/EUCTR2013-004724-11-SE
EUCTR2013-004724-11-SE
Active, not recruiting
Phase 1

Surgical treatment of peri-implantitis with and without systemically adjunctive antibioticsA prospective, open, randomized, three armed, parallel, placebo controlled clinical trial

Karolinska Institute0 sites66 target enrollmentJuly 25, 2014
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Conditionsperi-implantitisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsKåvepenin 800 mgFlagyl Sanofi 400 mgAmoxicillin Sandoz 500 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
peri-implantitis
Sponsor
Karolinska Institute
Enrollment
66
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 25, 2014
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska Institute

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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