E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
inflammation of the soft and hard tissues surrounding a dental implant |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
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 |
The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with surgical treatment of peri-implantitis |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the microbiological effectiveness of the peri-implantitis treatment approach under investigation in this trial. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) The patient is ≥ 18 years of age;
2) The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
3) The implants have been in function for at least two years;
4) The patient is capable of understanding and giving informed consent. |
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E.4 | Principal exclusion criteria |
1) Medical and general contraindications for the surgical procedures;
2) A history of local radiotherapy to the head and neck region;
3) Pregnancy and lactation;
4) Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
5) Mononucleosis infectiosa
6) Organic neurological disorders
7) Use of antibiotics during the last 3 months;
8) Known allergy to amoxicillin, metronidazole or chlorhexidine;
9) Long-term use of anti-inflammatory drugs;
10) Full edentulism (no remaining teeth, only implants)
11) Active periodontal disease at remaining dentition (PPD≥6mm, bleeding≥20%) and/or insufficient oral hygiene (plaque≥20%)
12) Implants placed in areas augmented with autogenous bone from the crista iliac region;
13) Implants placed in skin grafted areas;
14) Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
15) Implant mobility;
16) Implants at which no position can be identified where proper probing measurements can be performed;
17) Previous surgical treatment of the peri-implantitis lesions; |
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E.5 End points |
E.5.1 | Primary end point(s) |
absence of bleeding and/or suppuration on peri-implant probing |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 and 12 months after active treatment |
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E.5.2 | Secondary end point(s) |
1) Full-mouth periodontal bleeding score (%);
2) Full-mouth periodontal suppuration on probing score (%);
3) Full-mouth peri-implant and periodontal probing pocket depth;
4) Full-mouth peri-implant and periodontal plaque score (%);
5) Marginal soft tissue recession (REC);
6) Radiographic marginal peri-implant bone level on standardized intraoral radiographs;
7) Microbiological composition of the peri-implant and periodontal area;
8) Implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection;
9) Complications and adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 and 12 months after active treatment |
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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 | Yes |
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
only surgical treatment (no additional medicinal product) |
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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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Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons. |
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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 | |