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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
Sponsor:
Collaborator:
Umeå University
Information provided by (Responsible Party):
Catrine Isehed, Region Gävleborg

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgery and Emdogain®
access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline
 Device: Emdogain®
Surgery and Emdogain®
Other Names:
  • enamel matrix derivative
  • enamel matrix proteins
Placebo Comparator: Surgery alone
access peri-implant surgery and cleaning of implant surface with saline
 Device: Surgery alone
Surgery alone


Outcome Measures
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Primary Outcome Measures :
  1. Changes in marginal bone level at dental implant [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in peri-implant microflora incidence and composition [ Time Frame: 2weeks, 3, 6, 12 months ]
  2. Changes in peri-implant pocket depth [ Time Frame: 12 months ]
  3. Number of sites with bleeding on probing [ Time Frame: 3,6, 9, 12 months ]
  4. Number of sites with bacterial plaque at the implant [ Time Frame: 3,6, 9, 12 months ]
  5. Number of sites with suppuration on probing [ Time Frame: 3,6, 9, 12 months ]
  6. Number of sites with marginal gingival recession [ Time Frame: 3,6, 9, 12 months ]
  7. Full mouth plaque score [ Time Frame: 3,6, 9, 12 months ]
  8. Full mouth bleeding score [ Time Frame: 3,6, 9, 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sweden
Sweden
Gävle, Sweden
Sponsors and Collaborators
Catrine Isehed
Umeå University
Investigators
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Principal Investigator: Pernilla Lundberg, Assoc. Prof Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, pernilla.lundberg@umu.se
More Information
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Publications:

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Responsible Party: Catrine Isehed, DDS, periodontist, Region Gävleborg
ClinicalTrials.gov Identifier: NCT02500654    
Other Study ID Numbers: CFUG 476871
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Catrine Isehed, Region Gävleborg:
Peri-implantitis
Regenerative therapy
Surgical therapy
 Enamel matrix derivative
Peri-implant microflora
Peri-implant fluid
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Periodontal Diseases
Peri-Implantitis
 Mouth Diseases
Inflammation
Pathologic Processes
Stomatognathic Diseases