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Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

Primary Purpose

Peri-implantitis, Periodontal Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amoxicillin 500 mg + metronidazole 500 mg
non-surgical periodontal and peri-implant treatment
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antibiotics group

    Control group

    Arm Description

    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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.

    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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.

    Outcomes

    Primary Outcome Measures

    change from baseline mean peri-implant bleeding score at 3 months
    in percentages ranging from 0 (no change) to 100 (improvement)

    Secondary Outcome Measures

    change from baseline full-mouth periodontal bleeding score at 3 months
    in percentages ranging from 0 (no change) to 100 (improvement)
    change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months
    in percentages ranging from 0 (no change) to 100 (improvement)
    change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months
    in millimeters ranging from 0 (no change) to high (improvement)
    change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months
    in percentages ranging from 0 (no change) to 100 (improvement)
    change from baseline marginal soft tissue level at 3 months
    in millimeters ranging from 0 (no change) to high (worsening)
    change from baseline radiographic marginal peri-implant bone level at 3 months
    in millimeters ranging from 0 (no change) to high (worsening)
    change from baseline in detection frequency of 7 periodontal pathogens potentially residing in the peri-implant and periodontal area at 3 months
    number of patients in need for additional surgery at teeth and implants
    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
    number of patients with tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection
    number of patients with adverse events related to the treatment

    Full Information

    First Posted
    October 26, 2019
    Last Updated
    March 24, 2020
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04149327
    Brief Title
    Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment
    Official Title
    Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2012 (Actual)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-implantitis, Periodontal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotics group
    Arm Type
    Experimental
    Arm Description
    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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    amoxicillin 500 mg + metronidazole 500 mg
    Intervention Description
    500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days
    Intervention Type
    Procedure
    Intervention Name(s)
    non-surgical periodontal and peri-implant treatment
    Intervention Description
    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 Outcome Measure Information:
    Title
    change from baseline mean peri-implant bleeding score at 3 months
    Description
    in percentages ranging from 0 (no change) to 100 (improvement)
    Time Frame
    3 months after therapy
    Secondary Outcome Measure Information:
    Title
    change from baseline full-mouth periodontal bleeding score at 3 months
    Description
    in percentages ranging from 0 (no change) to 100 (improvement)
    Time Frame
    3 months after therapy
    Title
    change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months
    Description
    in percentages ranging from 0 (no change) to 100 (improvement)
    Time Frame
    3 months after therapy
    Title
    change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months
    Description
    in millimeters ranging from 0 (no change) to high (improvement)
    Time Frame
    3 months after therapy
    Title
    change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months
    Description
    in percentages ranging from 0 (no change) to 100 (improvement)
    Time Frame
    3 months after therapy
    Title
    change from baseline marginal soft tissue level at 3 months
    Description
    in millimeters ranging from 0 (no change) to high (worsening)
    Time Frame
    3 months after therapy
    Title
    change from baseline radiographic marginal peri-implant bone level at 3 months
    Description
    in millimeters ranging from 0 (no change) to high (worsening)
    Time Frame
    3 months after therapy
    Title
    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
    Title
    number of patients in need for additional surgery at teeth and implants
    Time Frame
    3 months after therapy
    Title
    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
    Title
    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
    Title
    number of patients with adverse events related to the treatment
    Time Frame
    3 months after therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

    Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

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