Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics
Primary Purpose
Periodontal Diseases, Periimplantitis
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Placebo
Amoxicillin Sandoz
Metronidazole Sanofi
Phenoxymethylpenicillin Meda
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
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.
Sites / Locations
- Folktandvården Skanstull
- Folktandvården Kaniken
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Placebo
amoxicillin + metronidazole
phenoxymetylpencillin + metronidazol
Arm Description
Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)
Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days
Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days
Outcomes
Primary Outcome Measures
Probing pocket depth change and bone level stability
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185209
Brief Title
Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics
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 Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Margareta Hultin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periimplantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)
Arm Title
amoxicillin + metronidazole
Arm Type
Active Comparator
Arm Description
Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days
Arm Title
phenoxymetylpencillin + metronidazol
Arm Type
Active Comparator
Arm Description
Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Place capsule to mimic antibiotics
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Sandoz
Intervention Description
Tablet 500 mg amoxicillin Sandoz three times a day
Intervention Type
Drug
Intervention Name(s)
Metronidazole Sanofi
Intervention Description
400 mg metronidazole Sanofi administered three times a day (TID)
Intervention Type
Drug
Intervention Name(s)
Phenoxymethylpenicillin Meda
Intervention Description
1600 mg phenoxymethylpenicillin Meda, three time a day (TID)
Primary Outcome Measure Information:
Title
Probing pocket depth change and bone level stability
Time Frame
0,6 and 12 months
Secondary Outcome Measure Information:
Title
Change of clinical soft tissue inflammation, bleeding on probing (BOP)
Time Frame
0, post operative 12 month
Title
Soft tissue recession (REC) and clinical attachment level gain (CAL)
Time Frame
0,6 and 12 month
Title
• Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora
Time Frame
0,6 and 12 months
Title
• Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.
Time Frame
0,6 and 12 month
Title
Quantitative and qualitative changes in the oral and intestinal microflora
Time Frame
0,6 and 12 month
Title
Concentration of amoxicillin, metronidazole and PcV in saliva and feces
Time Frame
0, 6 and 12 month
Title
• Follow-up of adverse events related or unrelated to the investigated medical products
Time Frame
0,6, and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Hultin, DDSass. prof
Organizational Affiliation
Karolinska Institute, Dental medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bodil Lund, DDSass.prof
Organizational Affiliation
Karolinska Institute, Dental Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dalia Kahlil, DDS, PhDstud
Organizational Affiliation
Karolinska Institute, Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Folktandvården Skanstull
City
Stockholm
ZIP/Postal Code
SE-118 62
Country
Sweden
Facility Name
Folktandvården Kaniken
City
Uppsala
ZIP/Postal Code
SE 753 09
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics
We'll reach out to this number within 24 hrs