E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients requiring bone augmentation procedure prior to, or in conjunction to installation of dental implants. |
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E.1.1.1 | Medical condition in easily understood language |
Patients needing bone transplants before dental implantation. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
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 | 10049924 |
E.1.2 | Term | Infection prophylaxis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
To evaluate the effect of short or prolonged antibiotic prophylaxis respectively, on occurence of postoperative infections after bone augmentation procedures in conjunction with, or prior to, dental implant treatment. |
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E.2.2 | Secondary objectives of the trial |
To evaluate impact on and recovery time for the normal oral and intestinal microflora after a single dose antimicrobial prophylaxis and prolonged prophylaxis, respectively. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female ≥18-80 year 2. Partially or completely edentulous subjects with healthy or treated periodontal conditions. 3. Patients who have been referred by a general dentist or specialist in prosthodontics to a specialist clinic in oral and maxillofacial surgery, for treatment with dental implants. 4. Inadequate amount of bone to allow insertion of dental implant according to the operating surgeon. 5. Signed informed consent.
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E.4 | Principal exclusion criteria |
1. Known allergy to amoxicillin, phenoxymethylpenicillin or other betalactam antibiotic. 2. Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8–9 %, 64– 75 mmol/ml), osteoporosis, i.v. bisphosphonate treatment due to malignancy, pregnant and lactating women). 3. Incapability to perform basal oral hygiene measures due to physical or mental disorders. 4. Received systemic antimicrobial therapy in the past three months. 5. Currently on allopurinol, probenicid, methotrexate or warfarin. 6. Untreated periodontal condition. 7. Active smoking. 8. Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize subjects’ safety. 9. Patients with xerostomia or having slow bowel motion (less than one stool daily) will be excluded from the group of subjects providing salivary and fecal samples. 10. Current participation in other medical study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of postoperative infection, which will be determined by evaluating the following parameters o Pus in surgical field (absolute indication of infection). Defined as discoloured exudate from surgical wound. o Occurrence of fistula in surgical field (absolute indication of infection). Defined as communication between oral cavity and implanted material through confirmed by using gingival pocket probe. o Swelling in surgical field (relative indication of infection and requires occurrence of one or more of the absolute indications). Defined as objective pathologic increase in tissue volume over surgical field compared to contralateral side or normal condition. o Pain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At visit 3 (day 14) Visit 4, 3 months after surgery Visit 5, 6 months after surgery Visit 6, 12 months after surgery |
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E.5.2 | Secondary end point(s) |
• Survival of augmented material and dental implants • Survival of dental implant (if applicable) • Dehiscence of bone augmented area. • Quantitative and qualitative change in levels of the oral and faecal microflora. • Changes in occurrence of antibiotic resistance in the oral and faecal microflora.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At visit 3 (day 14) Visit 4, 3 months after surgery Visit 5, 6 months after surgery Visit 6, 12 months after surgery |
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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 | 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) | Yes |
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 | No |
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 | 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 | No |
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
| 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 | 2 |
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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When the last subject has completed the last visit. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |