E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034539 |
E.1.2 | Term | Periodontitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
study with esamining clinicians blinded |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |