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Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Periodontal Diseases; Periimplantitis

Intervention: Placebo (Drug); Amoxicillin Sandoz (Drug); Metronidazole Sanofi (Drug); Phenoxymethylpenicillin Meda (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Margareta Hultin

Official(s) and/or principal investigator(s):
Margareta Hultin, DDSass. prof, Study Chair, Affiliation: Karolinska Institute, Dental medicine
Bodil Lund, DDSass.prof, Study Director, Affiliation: Karolinska Institute, Dental Medicine
Dalia Kahlil, DDS, PhDstud, Principal Investigator, Affiliation: Karolinska Institute, Dental Medicine

Overall contact:
Margareta Hultin, DDS, ass. prof, Phone: +46 (0)8-524 882 48, Email: margareta.hultin@ki.se


The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.

Clinical Details

Official title: Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics A Prospective, Double Blind, Randomized, Three Armed, Parallel, Placebo Controlled Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Probing pocket depth change and bone level stability

Secondary outcome:

Change of clinical soft tissue inflammation, bleeding on probing (BOP)

Soft tissue recession (REC) and clinical attachment level gain (CAL)

• Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora

• Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.

Quantitative and qualitative changes in the oral and intestinal microflora

Concentration of amoxicillin, metronidazole and PcV in saliva and feces

• Follow-up of adverse events related or unrelated to the investigated medical products

Detailed description: 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)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Male or female ≥18-65 year 2. Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis. 3. Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year 4. Peri-implantitis is diagnosed when; PPD of ≥ 6mm can be found at a dental implant in association with BOP and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least ≥ 3 fixture threads). 5. Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program. 6. Full-Mouth Plaque Score (FMPS) ≤ 25 7. Signed informed consent Exclusion Criteria: 1. Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic 2. Contraindication for dental surgical treatment (i. e. immunocompromised, uncontrolled DM (B-GHb-A1C 8-9 %, 64-75 mmol/mol), 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, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin. 6. Known severe chronic peripheral or central disease of the nervous system 7. Known alcohol abuse 8. Known hepatic encephalopathy 9. Known lactose intolerance, galactose intolerance 10. Untreated periodontal condition. 11. Implant showing sign of mobility. 12. Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants. 13. 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 patient safety Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.

Locations and Contacts

Margareta Hultin, DDS, ass. prof, Phone: +46 (0)8-524 882 48, Email: margareta.hultin@ki.se

Folktandvården Skanstull, Stockholm SE-118 62, Sweden; Recruiting
Caroline Grundström, O.D, Email: Caroline.Grundström@ftv.sll.se
Caroline Grundström, O.D, Principal Investigator
Leif Jansson, O.D, Sub-Investigator

Folktandvården Kaniken, Uppsala SE 753 09, Sweden; Recruiting
Saeed Shamani, O.D, Phone: +46(0)18 611 63 80, Email: saeed.shamani@ki.se
Britt-Marie Herdevall, O.D, Sub-Investigator

Additional Information

Starting date: March 2015
Last updated: March 31, 2015

Page last updated: August 23, 2015

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