E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) |
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E.1.1.1 | Medical condition in easily understood language |
patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) |
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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 |
To evaluate the effect of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) in regard to patient-centered outcomes. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Medically healthy adult (ASA classification I-II), age ≥ 21 years old 2. Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day 3. Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch 4. Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019). 5. Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
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E.4 | Principal exclusion criteria |
Medically compromised subjects (ASA classification III-V) 2. General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication) 3. Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy 4. Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day) 5. Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch 6. Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment 7. Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients). 8. Need for 2 stage sinus augmentation 9. Acute or unmanaged symptomatic sinusitis
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E.5 End points |
E.5.1 | Primary end point(s) |
Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS on the wound (pain, swelling, bruising (haematoma), bleeding) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week 2, 4, 16-20 and 6 months after crown- installation |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |