Regenerative Surgical Treatment of Peri-implantitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.

Conditions
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Failure of Dental Implant Due to Infection, Infection, Inflammation, Peri-implantitis, Bacterial Infections, Bleeding of Subgingival Space, Molecular Sequence Variation, Periodontal Diseases, Mouth Diseases

Intervention / Treatment
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* Device: Emdogain®
* Device: Surgery alone


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery and Emdogain®<br>access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline | Device: Emdogain®<br>* Surgery and Emdogain®<br>* Other names: enamel matrix proteins;|
| Placebo Comparator: Surgery alone<br>access peri-implant surgery and cleaning of implant surface with saline | Device: Surgery alone<br>* Surgery alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in marginal bone level at dental implant |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in peri-implant microflora incidence and composition |  | 2weeks, 3, 6, 12 months | 
| Changes in peri-implant pocket depth |  | 12 months | 
| Number of sites with bleeding on probing |  | 3,6, 9, 12 months | 
| Number of sites with bacterial plaque at the implant |  | 3,6, 9, 12 months | 
| Number of sites with suppuration on probing |  | 3,6, 9, 12 months | 
| Number of sites with marginal gingival recession |  | 3,6, 9, 12 months | 
| Full mouth plaque score |  | 3,6, 9, 12 months | 
| Full mouth bleeding score |  | 3,6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implantitis, Regenerative therapy, Surgical therapy, Enamel matrix derivative, Peri-implant microflora, Peri-implant fluid