E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical extraction of third molars |
operative Weisheitszahnentfernung |
|
E.1.1.1 | Medical condition in easily understood language |
Extraction of wisdom teeth |
Weisheitszahnentfernung |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047991 |
E.1.2 | Term | Wisdom teeth removal |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038349 |
E.1.2 | Term | Removal of wisdom teeth |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 |
To evaluate whether the perioperative usage of antibiotics is effective in reducing postoperative complications, compared to placebo, in patients undergoing wisdom teeth removal. |
Evaluierung, ob eine perioperative Antibiotikagabe bei Weisheitszahnoperationen einen zusätzlichen Benefit im Hinblick auf eine Reduktion von postoperativen Komplikationen bewirkt, verglichen mit Placebo, bei Patienten nach operativen Weisheitszahnentfernungen. |
|
E.2.2 | Secondary objectives of the trial |
Experience of pain, swelling and bleeding |
Auftreten von Schmerzen, Schwellungen, Blutungen |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Symptom-free, bilaterally located third molars -Medically healthy patient ≥ 16 years - No allergies/intolerances against the investigational product/placebo - Informed consent
|
•Symptomfreie, beidseitig angelegte OK/UK Weisheitszähne •≥ 16 Jahre alt •Medizinisch gesunder Patient •Keine Allergie gegen Amoxicillin oder Penicillin und/oder Lactosum monohydricum PHE und/oder Gelatine •Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung
|
|
E.4 | Principal exclusion criteria |
-General contraindications to wisdom tooth extraction surgery -(Former) heavy smoking -Use of antibiotics within the last three months or patients requiring antiobiotic treatment prior to surgery -(Planned) Pregnancy/lactating
|
-Allgemeine Kontraindikationen für operative Weisheitszahnentfernungen -(Ehemaliges) starkes Rauchen -Anwendung von Antibiotika innerhalb der letzten 3 Monate oder Patienten die eine Antibiotikaprophylaxe vor dem Eingriff benötigen •Schwangere oder Patientinnen die planen schwanger zu werden oder zu stillen
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Inflammatory complications (swelling, purulence, mouth opening restriction) |
Entzündliche Komplikationen (Schwellung, Pusentleerung, Mundöffnungseinschränkung) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
7 days post surgery |
7 Tage post OP |
|
E.5.2 | Secondary end point(s) |
Occurrence of pain, bleeding, swelling |
Auftreten von Schmerz, Blutung, Schwellung |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
7 days post surgery |
7 Tage post OP |
|
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 | Yes |
E.6.4 | Safety | No |
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 | 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) | 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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
LVLS |
Letzte Visite des letzten Studienpatienten |
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |