NCT02500654

Regenerative Surgical Treatment of Peri-implantitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Catrine Isehed · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Emdogain®	Surgery and Emdogain®
DEVICE	Surgery alone	Surgery alone

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2015-07-16
• Last updated: 2016-09-01

Locations

1 site across 1 country: Sweden