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NCT Number: NCT04149327

Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach.

The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study.

Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe.

The main study parameter is the mean peri-implant bleeding score.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient is ≥ 18 years of age;
  • 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;
  • The implants have been in function for at least two years;
  • The patient is capable of understanding and giving informed consent.

Exclusion criteria

  • Medical and general contraindications for the surgical procedures;
  • A history of local radiotherapy to the head and neck region;
  • Pregnancy and lactation;
  • Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
  • Mononucleosis infectiosa
  • Organic neurological disorders
  • Use of antibiotics during the last 3 months;
  • Known allergy to amoxicillin, metronidazole or chlorhexidine;
  • Long-term use of anti-inflammatory drugs;
  • Full edentulism (no remaining teeth, only implants)
  • Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
  • Implants placed in areas augmented with autogenous bone from the crista iliac region;
  • Implants placed in skin grafted areas;
  • 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;
  • Implant mobility;
  • Implants at which no position can be identified where proper probing measurements can be performed;
  • Previous surgical treatment of the peri-implantitis lesions;
  • Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage)

Treatment and study plan

amoxicillin 500 mg + metronidazole 500 mg

Drug

500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days

non-surgical periodontal and peri-implant treatment

Procedure

Patients are instructed on how to perform proper oral hygiene measures using an electric toothbrush, interdental brushes (to be used in combination with Corsodyl® gel) and floss (Oral-B® superfloss or Meridol® floss, at implants only).

Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned.

Primary outcomes

  1. change from baseline mean peri-implant bleeding score at 3 months

    Time frame: 3 months after therapy

    in percentages ranging from 0 (no change) to 100 (improvement)

Secondary outcomes

  1. change from baseline full-mouth periodontal bleeding score at 3 months

    Time frame: 3 months after therapy

    in percentages ranging from 0 (no change) to 100 (improvement)

  2. change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months

    Time frame: 3 months after therapy

    in percentages ranging from 0 (no change) to 100 (improvement)

  3. change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months

    Time frame: 3 months after therapy

    in millimeters ranging from 0 (no change) to high (improvement)

  4. change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months

    Time frame: 3 months after therapy

    in percentages ranging from 0 (no change) to 100 (improvement)

  5. change from baseline marginal soft tissue level at 3 months

    Time frame: 3 months after therapy

    in millimeters ranging from 0 (no change) to high (worsening)

  6. change from baseline radiographic marginal peri-implant bone level at 3 months

    Time frame: 3 months after therapy

    in millimeters ranging from 0 (no change) to high (worsening)

  7. change from baseline in detection frequency of 7 periodontal pathogens potentially residing in the peri-implant and periodontal area at 3 months

    Time frame: 3 months after therapy

  8. number of patients in need for additional surgery at teeth and implants

    Time frame: 3 months after therapy

  9. number of patients with 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

    Time frame: 3 months after therapy

  10. number of patients with tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection

    Time frame: 3 months after therapy

  11. number of patients with adverse events related to the treatment

    Time frame: 3 months after therapy

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2019
Registry last updated
Apr 19, 2024

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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