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The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.
This study will give the opportunity to draw scientifically based conclusions on the recommendations of the use of adjunctive systemic antibiotics in the treatment of peri-implantitis. This study will also be able to determine the ecological impact on the oropharyngeal and intestinal microflora between different antibiotic treatments. The lack of knowledge in this area has been highlighted by the Food and Drug Administration and The Swedish Council on Health Technology Assessment (SBU)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID) |
|
| amoxicillin + metronidazole | Active Comparator | Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days |
|
| phenoxymetylpencillin + metronidazol | Active Comparator | Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Place capsule to mimic antibiotics |
| |
| Amoxicillin Sandoz |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth change and bone level stability | 0,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of clinical soft tissue inflammation, bleeding on probing (BOP) | 0, post operative 12 month | |
| Soft tissue recession (REC) and clinical attachment level gain (CAL) | 0,6 and 12 month | |
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Inclusion Criteria:
Exclusion Criteria:
Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.
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| Name | Affiliation | Role |
|---|---|---|
| Margareta Hultin, DDSass. prof | Karolinska Institute, Dental medicine | Study Chair |
| Bodil Lund, DDSass.prof | Karolinska Institute, Dental Medicine | Study Director |
| Dalia Kahlil, DDS, PhDstud | Karolinska Institute, Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Folktandvården Skanstull | Stockholm | SE-118 62 | Sweden | |||
| Folktandvården Kaniken |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42184963 | Derived | Riben Grundstrom C, Lund B, Bostanci N, Silbereisen A, Pennhag A, Koistinen IS, Zha Y, Damdimopoulos A, Belibasakis GN, Hultin M. Systemic Antibiotics in the Surgical Treatment of Peri-Implantitis: Impact on the Salivary Microbiome. J Clin Periodontol. 2026 May 25. doi: 10.1111/jcpe.70143. Online ahead of print. | |
| 38699828 | Derived |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Drug |
Tablet 500 mg amoxicillin Sandoz three times a day |
|
| Metronidazole Sanofi | Drug | 400 mg metronidazole Sanofi administered three times a day (TID) |
|
| Phenoxymethylpenicillin Meda | Drug | 1600 mg phenoxymethylpenicillin Meda, three time a day (TID) |
|
| • Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora |
| 0,6 and 12 months |
| • Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin. | 0,6 and 12 month |
| Quantitative and qualitative changes in the oral and intestinal microflora | 0,6 and 12 month |
| Concentration of amoxicillin, metronidazole and PcV in saliva and feces | 0, 6 and 12 month |
| • Follow-up of adverse events related or unrelated to the investigated medical products | 0,6, and 12 month |
| Uppsala |
| SE 753 09 |
| Sweden |
| Riben Grundstrom C, Lund B, Kampe J, Belibasakis GN, Hultin M. Systemic antibiotics in the surgical treatment of peri-implantitis: A randomized placebo-controlled trial. J Clin Periodontol. 2024 Aug;51(8):981-996. doi: 10.1111/jcpe.13994. Epub 2024 May 3. |