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Completed

NCT Number: NCT01517334

Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.

The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Maryland, School of Dentistry, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
  • Absence of any significant oral soft tissue pathology
  • At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
  • Confirmed evidence of pathologic bone loss
  • At least 1mm of keratinized gingiva present around the implant

Exclusion criteria

  • Pregnancy
  • Allergy to tetracycline-class drug(s)
  • Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
  • Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
  • Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
  • Signs of untreated advanced periodontal disease and/or poor oral hygiene
  • Subjects having a probing depth greater than 8mm at time of enrollment
  • Subjects presenting with mobility of any dental implant
  • Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)

Treatment and study plan

minocycline HCl microspheres

Drug

Other names: Arestin (brand name)

Primary outcomes

  1. Change in mean Probing Depth of qualifying implant sites

    Time frame: Baseline to Day 180

Secondary outcomes

  1. Change in percentage of qualifying implants with Bleeding On Probing

    Time frame: Baseline to Day 180

  2. Change in mean Probing Depth of qualifying implant sites

    Time frame: Baseline to Day 90

  3. Change in percentage of qualifying implants with Bleeding on Probing

    Time frame: Baseline to Day 90

Other outcomes

  1. Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)

    Time frame: Baseline to Day 30

Sponsors and collaborators

Lead sponsor

OraPharma

Industry

Registry information

Official study title

Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2012
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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