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Completed

NCT Number: NCT02185209

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Folktandvården Skanstull, Stockholm, Sweden

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18-65 year
  • Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
  • Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year
  • 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).
  • Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
  • Full-Mouth Plaque Score (FMPS) ≤ 25
  • Signed informed consent

Exclusion criteria

  • Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic
  • 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).
  • Incapability to perform basal oral hygiene measures due to physical or mental disorders.
  • Received systemic antimicrobial therapy in the past three months.
  • Currently on allopurinol, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin.
  • Known severe chronic peripheral or central disease of the nervous system
  • Known alcohol abuse
  • Known hepatic encephalopathy
  • Known lactose intolerance, galactose intolerance
  • Untreated periodontal condition.
  • Implant showing sign of mobility.
  • 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.
  • 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.

Treatment and study plan

Placebo

Drug

Place capsule to mimic antibiotics

Amoxicillin Sandoz

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)

Primary outcomes

  1. Probing pocket depth change and bone level stability

    Time frame: 0,6 and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Margareta Hultin

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2014
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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