peri-implantitis MedDRA version: 9.1 Level: LLT Classification code 10034539 Term: Periodontitis
Conditions
Interventions
Trade Name: PERITROL
Pharmaceutical Form: Dental powder
INN or Proposed INN: Minocycline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
OraPharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 21 years of age and in good general health subjects (and/or their legally acceptable representatives) must have read and signed an Informed Consent Form indicating that they fully understand the purpose and procedures required for the study and are willing to participate in the study. Each subject will receive a copy of his/her signed Informed Consent document. Willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. At time of enrollment, females must have a negative urine pregnancy results. Must be partially edentulous and free from any significant oral soft tissue pathology (Note: subjects who present with one fully edentulous arch are still eligible for participating in the study). Must have a minimum of one* (1) osseointegrated, implant with a diagnosis of peri-implantitis defined as at least one peri-implant site with PD ≥5 mm when using a light force (0.2N) with BOP within 30 seconds of the probing and evidence of pathologic bone loss. Furthermore, there must be a presence of at least 1mm of keratinized gingiva around the implant. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Females self-reporting pregnancy or lactation, or having a positive urine pregnancy results at the time of enrollment (***see below). Subjects reporting allergy to a tetracycline-class drug Subjects with any systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures Subjects with any active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis Subjects diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement Subjects who have taken an investigational drug within 30 days of enrollment Subjects who have participated in a dental clinical trial within 30 days of enrollment Employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator Any subject that at the discretion of the investigator should not be included in the study *** If a female subject in the Test Group reports pregnancy at either interim visit, no study drug will be re-administered and the subject will be included in the intent-to-treat (ITT) analysis, but will be excluded from per-protocol (PP) analysis. Subjects presenting with signs of advanced periodontal disease and/or poor oral hygiene Subjects having a PD >7mm at any peri-implant site(s) 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 examiner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the safety and efficacy of a locally delivered antibiotic, minocycline HCl microspheres, for the treatment of peri-implantitis, when used as an adjunct to mechanical debridement. Efficacy will be determined using manual measurements of reduction of probing depth (PD) at Day 180 as the primary criterion.;Secondary Objective: Evaluation of the gain in clinical attachment level (CAL), reduction in bleeding on probing (BOP), changes in bone level and reduction in inflammatory biomarkers [specifically, carboxyl-terminal telopeptide of type I collagen (ICTP) and interleukin-1 (IL-1)] ICTP and IL-1 Safety will be assessed through the recording of all adverse Event.;Primary end point(s): Efficacy will be determined using manual measurements of reduction of probing depth (PD) at Day 180 as the primary criterion. Secondary criteria for efficacy will be gain in clinical attachment level (CAL), reduction in bleeding on probing (BOP), changes in bone level and reduction in inflammatory biomarkers [specifically, carboxyl-terminal telopeptide of type I collagen (ICTP) and interleukin-1 (IL-1)] ICTP and IL-1 Safety will be assessed through the recording of all adverse Event. | — |
Countries
Italy
Outcome results
None listed