E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoatrophie im Alveolarknochenregio. |
|
E.1.1.1 | Medical condition in easily understood language |
Bone loss in jawbone. |
Knochenabbau im Kieferbereich. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
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 |
There are no clinical advantages of a prae- and post-operation antibiotics therapy. |
Durch eine prae- und postoperative AB-Gabe lässt sich kein klinischer Vorteil erzielen. |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of systemic antibiotic prophylaxis on patient-centred outcomes and perception following oral implant therapy and guided bone regeneration. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy people (ASA I-II) with a minimum age of 21, preferably non-smokers, no allergy against Amoxicillin or Penicillin, bone loss at class 1-3 (Schincaglia and Nowzari) |
Medizinisch gesunde Patienten/Innen (ASA I-II), Mindestalter von 21 Jahren, vorzugsweise Nicht-Raucher, keine Allergien gegen Amoxicillin oder Penizillin, Zahnlücken mit knöchernen Defekt der Klasse 1-3 (Schincaglia and Nowzari) |
|
E.4 | Principal exclusion criteria |
Medical compromised person (ASA III-V), general contraindications against implants, therapies which influence the bone and soft tissue regeneration, smokers, allergics against amoxicillin or penicillin, antibiotics taken in the last 3 months or patients with antibiotics prohylaxe, pregnancy or pregnancy in planning or nurseing, tooth gaps with b-l bone-dimensions<3mm, m-d dimensions<7mm and <8mm high, patients under 21, |
medizinisch kompromittierte Personen (ASA III-V), generelle Kontraindikationen gegen Implantattherapie, Therapien oder Erkrankungen die den Knochen- oder Weichgewebs-Stoffwechsel beeinflussen, schwere Raucher oder ehemals schwere Raucher, Allergie gegen Amoxicillin oder Penicillin, Anwenung von Antibiotika innerhalb der letzten 3 Monate oder Patienten die eine AB-Prophylaxe vor dem Eingriff benötigen, Schwangere oder Patientinnen die Planen schwanger zu werden oder zu Stillen, Zahnlücken mit b-l Knochendimensionen<3mm, m-d Dimension <7mm und <8mm Höhe, Patient/Innen unter 21 Jahren. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
For the test group, the risk involved would be the development of antibiotic resistance and known side-effects of the drug used, like diarrhoea. As for the control group, there may be an increased risk of infection and post-operative complications following the procedure, and possible increased risk of early implant loss |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
multizentrisch |
multicentre |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 |
Australia |
China |
Hong Kong |
Iceland |
Singapore |
|
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
|
The trial starts from July 2014 and the trial will end in December 2017 |
Die Studie beginnt mit Juli 2014 und läuft bis Ende Dezember 2017. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |