Regenerative Surgical Treatment of Peri-implantitis
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|ClinicalTrials.gov Identifier: NCT02500654|
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : September 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Failure of Dental Implant Due to Infection Infection Inflammation Peri-implantitis Bacterial Infections Bleeding of Subgingival Space Molecular Sequence Variation Periodontal Diseases Mouth Diseases||Device: Emdogain® Device: Surgery alone||Phase 4|
This is a randomised controlled clinical trial. Recruiting 31 patient with periimplantitis at one or more implants in need for surgical treatment.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Surgery and Emdogain®
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
Surgery and Emdogain®
Placebo Comparator: Surgery alone
access peri-implant surgery and cleaning of implant surface with saline
Device: Surgery alone
- Changes in marginal bone level at dental implant [ Time Frame: 12 months ]
- Changes in peri-implant microflora incidence and composition [ Time Frame: 2weeks, 3, 6, 12 months ]
- Changes in peri-implant pocket depth [ Time Frame: 12 months ]
- Number of sites with bleeding on probing [ Time Frame: 3,6, 9, 12 months ]
- Number of sites with bacterial plaque at the implant [ Time Frame: 3,6, 9, 12 months ]
- Number of sites with suppuration on probing [ Time Frame: 3,6, 9, 12 months ]
- Number of sites with marginal gingival recession [ Time Frame: 3,6, 9, 12 months ]
- Full mouth plaque score [ Time Frame: 3,6, 9, 12 months ]
- Full mouth bleeding score [ Time Frame: 3,6, 9, 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500654
|Principal Investigator:||Pernilla Lundberg, Assoc. Prof||Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, firstname.lastname@example.org|