Clinical trial NCT01517334: Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peri-Implantitis
Lead sponsor: OraPharma
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in mean Probing Depth of qualifying implant sites
timeFrame: Baseline to Day 180
Secondary outcomes:
measure: Change in percentage of qualifying implants with Bleeding On Probing
timeFrame: Baseline to Day 180
measure: Change in mean Probing Depth of qualifying implant sites
timeFrame: Baseline to Day 90
measure: Change in percentage of qualifying implants with Bleeding on Probing
timeFrame: Baseline to Day 90
Other outcomes:
measure: Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)
timeFrame: Baseline to Day 30
Locations:
city: Baltimore
country: United States
facility: University of Maryland, School of Dentistry
state: Maryland
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Michigan Center for Oral Health Research
state: Michigan
city: Kansas City
country: United States
facility: University of Missouri - Kansas City School of Dentistry Clinical Research Center
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Dentistry
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Dental Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina College of Dental Medicine
state: South Carolina
city: Memphis
country: United States
facility: UTHSC - College of Dentistry
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Dentistry
state: Virginia
city: Milwaukee
country: United States
facility: Marquette University School of Dentstry
state: Wisconsin
Study officials:
affiliation: University of North Carolina - Chapel Hill Dental School
name: Steven Offenbacher, DDS
role: PRINCIPAL_INVESTIGATOR
References: