Regenerative Surgical Treatment of Peri-implantitis
Primary Purpose
Failure of Dental Implant Due to Infection, Infection, Inflammation
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Emdogain®
Surgery alone
Sponsored by
About this trial
This is an interventional treatment trial for Failure of Dental Implant Due to Infection focused on measuring Peri-implantitis, Regenerative therapy, Surgical therapy, Enamel matrix derivative, Peri-implant microflora, Peri-implant fluid
Eligibility Criteria
Inclusion Criteria:
- peri-implant angular bone loss ≥3 mm, measured at radiographs
- deep pocket ≥5 mm combined with bleeding and/or pus
Exclusion Criteria:
- individuals with uncontrolled diabetes (HbA1c > 7,0%)
- 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
Sites / Locations
- Sweden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Surgery and Emdogain®
Surgery alone
Arm Description
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
access peri-implant surgery and cleaning of implant surface with saline
Outcomes
Primary Outcome Measures
Changes in marginal bone level at dental implant
Secondary Outcome Measures
Changes in peri-implant microflora incidence and composition
Changes in peri-implant pocket depth
Number of sites with bleeding on probing
Number of sites with bacterial plaque at the implant
Number of sites with suppuration on probing
Number of sites with marginal gingival recession
Full mouth plaque score
Full mouth bleeding score
Full Information
NCT ID
NCT02500654
First Posted
July 15, 2015
Last Updated
August 31, 2016
Sponsor
Catrine Isehed
Collaborators
Umeå University
1. Study Identification
Unique Protocol Identification Number
NCT02500654
Brief Title
Regenerative Surgical Treatment of Peri-implantitis
Official Title
Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catrine Isehed
Collaborators
Umeå University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure of Dental Implant Due to Infection, Infection, Inflammation, Peri-implantitis, Bacterial Infections, Bleeding of Subgingival Space, Molecular Sequence Variation, Periodontal Diseases, Mouth Diseases
Keywords
Peri-implantitis, Regenerative therapy, Surgical therapy, Enamel matrix derivative, Peri-implant microflora, Peri-implant fluid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery and Emdogain®
Arm Type
Experimental
Arm Description
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
Arm Title
Surgery alone
Arm Type
Placebo Comparator
Arm Description
access peri-implant surgery and cleaning of implant surface with saline
Intervention Type
Device
Intervention Name(s)
Emdogain®
Other Intervention Name(s)
enamel matrix derivative, enamel matrix proteins
Intervention Description
Surgery and Emdogain®
Intervention Type
Device
Intervention Name(s)
Surgery alone
Intervention Description
Surgery alone
Primary Outcome Measure Information:
Title
Changes in marginal bone level at dental implant
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in peri-implant microflora incidence and composition
Time Frame
2weeks, 3, 6, 12 months
Title
Changes in peri-implant pocket depth
Time Frame
12 months
Title
Number of sites with bleeding on probing
Time Frame
3,6, 9, 12 months
Title
Number of sites with bacterial plaque at the implant
Time Frame
3,6, 9, 12 months
Title
Number of sites with suppuration on probing
Time Frame
3,6, 9, 12 months
Title
Number of sites with marginal gingival recession
Time Frame
3,6, 9, 12 months
Title
Full mouth plaque score
Time Frame
3,6, 9, 12 months
Title
Full mouth bleeding score
Time Frame
3,6, 9, 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
peri-implant angular bone loss ≥3 mm, measured at radiographs
deep pocket ≥5 mm combined with bleeding and/or pus
Exclusion Criteria:
individuals with uncontrolled diabetes (HbA1c > 7,0%)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernilla Lundberg, Assoc. Prof
Organizational Affiliation
Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, pernilla.lundberg@umu.se
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sweden
City
Gävle
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25495683
Citation
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.
Results Reference
background
PubMed Identifier
20403112
Citation
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.
Results Reference
background
PubMed Identifier
25308100
Citation
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.
Results Reference
background
PubMed Identifier
22814555
Citation
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.
Results Reference
background
PubMed Identifier
25261052
Citation
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.
Results Reference
background
PubMed Identifier
15142219
Citation
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.
Results Reference
background
PubMed Identifier
18724844
Citation
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.
Results Reference
background
PubMed Identifier
22834392
Citation
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.
Results Reference
background
PubMed Identifier
12146539
Citation
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.
Results Reference
background
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Regenerative Surgical Treatment of Peri-implantitis
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