Study Results
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Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2008-12-31
2014-01-31
Brief Summary
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Detailed Description
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Randomisation to test group (EMD) with surgical treatment and additional application of enamel matrix derivative (Emdogain®) or surgical treatment alone in the control group (non-EMD).
Treatment of existing periodontitis performed before recruitment. Baseline examination including samples of microbiota and peri-implant fluid followed by surgical treatment. Access surgery to remove chronic inflammatory tissue and clean the implant surface from biofilm and implant stone with hand instrument and ultrasonic device with special tips for implants, followed by polishing the implant surface with a gauze, super floss and rinsing with saline. Allocation with a performed block randomisation at the stage of surgery, after cleaning of implant surface. Application of enamel matrix derivative (Emdogain®) or not, just before closure of flap. After surgery rinsing with chlorhexidine 0.2% twice a day in 6 weeks. No systemic antibiotic used in this study.
Supportive care program, including hygiene instructions and professional cleaning supragingival at implants and teeth at 2 weeks, 3, 6, 9 and 12 months after treatment.
Examination with measurements of pocket depth and bone levels at radiographs at baseline just before surgery and 12 months and prevalence of bleeding on probing, pus or recession as well as full mouth plaque score and full mouth bleeding score at 3, 6, 9 and 12 months.
Microbial sampling performed with endodontic paper points at baseline and 2 weeks after surgery as well 3, 6 and 12 months from implant site with at baseline the deepest pocket.
Sampling of the peri-implant fluid from the peri-implant pocket at baseline, 3, 6, and 12 months from implant site with at baseline the deepest pocket.
Removal of bridges performed to give accessibility at baseline examination/surgery and at 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgery and Emdogain®
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
Emdogain®
Surgery and Emdogain®
Surgery alone
access peri-implant surgery and cleaning of implant surface with saline
Surgery alone
Surgery alone
Interventions
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Emdogain®
Surgery and Emdogain®
Surgery alone
Surgery alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* deep pocket ≥5 mm combined with bleeding and/or pus
Exclusion Criteria
* individuals where prophylaxis of antibiotic is indicated
* medication with prednisolon or other anti-inflammatory drug
* medication with gingival hyperplasia known as a side effect
* systemic antibiotic intake the last 3 months
ALL
Yes
Sponsors
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Umeå University
OTHER
Catrine Isehed
OTHER
Responsible Party
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Catrine Isehed
DDS, periodontist
Principal Investigators
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Pernilla Lundberg, Assoc. Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, [email protected]
Locations
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Sweden
Gävle, , Sweden
Countries
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References
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Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
Heitz-Mayfield LJ, Lang NP. Comparative biology of chronic and aggressive periodontitis vs. peri-implantitis. Periodontol 2000. 2010 Jun;53:167-81. doi: 10.1111/j.1600-0757.2010.00348.x.
Maruyama N, Maruyama F, Takeuchi Y, Aikawa C, Izumi Y, Nakagawa I. Intraindividual variation in core microbiota in peri-implantitis and periodontitis. Sci Rep. 2014 Oct 13;4:6602. doi: 10.1038/srep06602.
Basegmez C, Yalcin S, Yalcin F, Ersanli S, Mijiritsky E. Evaluation of periimplant crevicular fluid prostaglandin E2 and matrix metalloproteinase-8 levels from health to periimplant disease status: a prospective study. Implant Dent. 2012 Aug;21(4):306-10. doi: 10.1097/ID.0b013e3182588408.
Carcuac O, Berglundh T. Composition of human peri-implantitis and periodontitis lesions. J Dent Res. 2014 Nov;93(11):1083-8. doi: 10.1177/0022034514551754. Epub 2014 Sep 26.
Holmlund A, Hanstrom L, Lerner UH. Bone resorbing activity and cytokine levels in gingival crevicular fluid before and after treatment of periodontal disease. J Clin Periodontol. 2004 Jun;31(6):475-82. doi: 10.1111/j.1600-051X.2004.00504.x.
Bosshardt DD. Biological mediators and periodontal regeneration: a review of enamel matrix proteins at the cellular and molecular levels. J Clin Periodontol. 2008 Sep;35(8 Suppl):87-105. doi: 10.1111/j.1600-051X.2008.01264.x.
Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.
Casati MZ, Sallum EA, Nociti FH Jr, Caffesse RG, Sallum AW. Enamel matrix derivative and bone healing after guided bone regeneration in dehiscence-type defects around implants. A histomorphometric study in dogs. J Periodontol. 2002 Jul;73(7):789-96. doi: 10.1902/jop.2002.73.7.789.
Other Identifiers
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CFUG 476871
Identifier Type: -
Identifier Source: org_study_id
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