Minocycline Microspheres for Peri-Implantitis

• Research type

  Research Study

• Full title

  Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects with Peri-Implantitis

• IRAS ID

  100604

• Contact name

  Nikolaos Donos

• Eudract number

  2012-000836-24

• Clinicaltrials.gov Identifier

  NCT01539564

• Research summary

  This is a research study that uses the drug Arestin© (Minocycline HCl 1 mg microspheres) as an experimental treatment for the ??peri-implantitis?. This condition is defined an inflammation affecting the tissues (gums and bone) around an already stable implant, resulting in loss of supporting jaw bone. It is caused by many factors but current research strongly links the condition with the presence of bacteria in the mouth which are responsible for periodontitis (gum disease). If left untreated, this can lead to decreased bone support, weakening of the implant and potential lost of the implant. Non-surgical treatment (mechanical debridement with instruments to remove plaque) and rigorous diligent oral care at home are commonly used to treat both peri-implantitis (gum disease around an implant) and periodontitis (gum disease around teeth). Arestin© is a licensed antibiotic drug which is approved by the US Food and Drug Administration (FDA) as a treatment for adult gum (periodontal) disease but not yet licensed as a treatment for peri-implantitis (gum disease around an implant), which is the rational for this trial. The antibiotic drug is administered as tiny microspheres (powder form) directly at the site of the affected gum/implant, to deliver a continuous localised effect. The primary aim of this study is to determine whether symptoms of peri-implantitis can be further improved by the application of localised (slow release) Arestin in addition to a standard deep cleaning treatment regime, as compared to standard deep cleaning alone. The study includes 215 individuals randomly assigned to either deep cleaning alone or deep cleaning plus Arestin. There are 4 visits that take place over 7 months. After an initial examination visit followed within 3 weeks by the treatment, follow-up will take place at Day 90, and Day 180 after treatment.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1647

• Date of REC Opinion

  20 Nov 2012

• REC opinion

  Further Information Favourable Opinion