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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02185209
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Margareta Hultin, Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Periodontal Diseases Periimplantitis Drug: Placebo Drug: Amoxicillin Sandoz Drug: Metronidazole Sanofi Drug: Phenoxymethylpenicillin Meda Phase 4

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Placebo
Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)
Drug: Placebo
Place capsule to mimic antibiotics
Active Comparator: amoxicillin + metronidazole
Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days
Drug: Amoxicillin Sandoz
Tablet 500 mg amoxicillin Sandoz three times a day
Drug: Metronidazole Sanofi
400 mg metronidazole Sanofi administered three times a day (TID)
Active Comparator: phenoxymetylpencillin + metronidazol
Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days
Drug: Metronidazole Sanofi
400 mg metronidazole Sanofi administered three times a day (TID)
Drug: Phenoxymethylpenicillin Meda
1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

Primary Outcome Measures :
  1. Probing pocket depth change and bone level stability [ Time Frame: 0,6 and 12 months ]

Secondary Outcome Measures :
  1. Change of clinical soft tissue inflammation, bleeding on probing (BOP) [ Time Frame: 0, post operative 12 month ]
  2. Soft tissue recession (REC) and clinical attachment level gain (CAL) [ Time Frame: 0,6 and 12 month ]
  3. • Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora [ Time Frame: 0,6 and 12 months ]
  4. • Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin. [ Time Frame: 0,6 and 12 month ]
  5. Quantitative and qualitative changes in the oral and intestinal microflora [ Time Frame: 0,6 and 12 month ]
  6. Concentration of amoxicillin, metronidazole and PcV in saliva and feces [ Time Frame: 0, 6 and 12 month ]
  7. • Follow-up of adverse events related or unrelated to the investigated medical products [ Time Frame: 0,6, and 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02185209

Contact: Margareta Hultin, DDS, ass. prof +46 (0)8-524 882 48
Contact: Bodil Lund, DDS prof

Folktandvården Skanstull Recruiting
Stockholm, Sweden, SE-118 62
Contact: Caroline Grundström, O.D       Caroline.Grundströ   
Principal Investigator: Caroline Grundström, O.D         
Sub-Investigator: Leif Jansson, O.D         
Folktandvården Kaniken Recruiting
Uppsala, Sweden, SE 753 09
Contact: Saeed Shamani, O.D    +46(0)18 611 63 80   
Sub-Investigator: Britt-Marie Herdevall, O.D         
Sponsors and Collaborators
Margareta Hultin
Study Chair: Margareta Hultin, DDSass. prof Karolinska Institute, Dental medicine
Study Director: Bodil Lund, Karolinska Institute, Dental Medicine
Principal Investigator: Dalia Kahlil, DDS, PhDstud Karolinska Institute, Dental Medicine

Responsible Party: Margareta Hultin, DDS, Karolinska Institutet Identifier: NCT02185209     History of Changes
Other Study ID Numbers: PERI-IMPL
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Penicillin V
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents