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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-05-27

Brief Summary

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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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Detailed Description

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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)

Conditions

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Periodontal Diseases Periimplantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Placebo

Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Place capsule to mimic antibiotics

amoxicillin + metronidazole

Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days

Group Type ACTIVE_COMPARATOR

Amoxicillin Sandoz

Intervention Type DRUG

Tablet 500 mg amoxicillin Sandoz three times a day

Metronidazole Sanofi

Intervention Type DRUG

400 mg metronidazole Sanofi administered three times a day (TID)

phenoxymetylpencillin + metronidazol

Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days

Group Type ACTIVE_COMPARATOR

Metronidazole Sanofi

Intervention Type DRUG

400 mg metronidazole Sanofi administered three times a day (TID)

Phenoxymethylpenicillin Meda

Intervention Type DRUG

1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

Interventions

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Placebo

Place capsule to mimic antibiotics

Intervention Type DRUG

Amoxicillin Sandoz

Tablet 500 mg amoxicillin Sandoz three times a day

Intervention Type DRUG

Metronidazole Sanofi

400 mg metronidazole Sanofi administered three times a day (TID)

Intervention Type DRUG

Phenoxymethylpenicillin Meda

1600 mg phenoxymethylpenicillin Meda, three time a day (TID)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No