Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Periodontal Diseases; Periimplantitis
Intervention: Placebo (Drug); Amoxicillin Sandoz (Drug); Metronidazole Sanofi (Drug); Phenoxymethylpenicillin Meda (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Margareta Hultin Official(s) and/or principal investigator(s):
Margareta Hultin, DDSass. prof, Study Chair, Affiliation: Karolinska Institute, Dental medicine
Bodil Lund, DDSass.prof, Study Director, Affiliation: Karolinska Institute, Dental Medicine
Dalia Kahlil, DDS, PhDstud, Principal Investigator, Affiliation: Karolinska Institute, Dental Medicine
Overall contact:
Margareta Hultin, DDS, ass. prof, Phone: +46 (0)8-524 882 48, Email: margareta.hultin@ki.se
Summary
The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in
the treatment of periimplantitis is needed.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Probing pocket depth change and bone level stability
Secondary outcome: 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
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Margareta Hultin, DDS, ass. prof, Phone: +46 (0)8-524 882 48, Email: margareta.hultin@ki.se
Folktandvården Skanstull, Stockholm SE-118 62, Sweden; Recruiting
Caroline Grundström, O.D, Email: Caroline.Grundström@ftv.sll.se
Caroline Grundström, O.D, Principal Investigator
Leif Jansson, O.D, Sub-Investigator
Folktandvården Kaniken, Uppsala SE 753 09, Sweden; Recruiting
Saeed Shamani, O.D, Phone: +46(0)18 611 63 80, Email: saeed.shamani@ki.se
Britt-Marie Herdevall, O.D, Sub-Investigator
Additional Information
Starting date: March 2015
Last updated: March 31, 2015
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