Regenerative Surgical Treatment of Peri-implantitis

Phase 4

Completed

• Conditions: Inflammation; Bleeding of Subgingival Space; Failure of Dental Implant Due to Infection; Infection; Bacterial Infections; Molecular Sequence Variation; Periodontal Diseases; Peri-implantitis; Mouth Diseases
• Interventions: Device: Surgery alone; Device: Emdogain®

• Registration Number: NCT02500654
• Lead Sponsor: Catrine Isehed

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery alone	Surgery alone	access peri-implant surgery and cleaning of implant surface with saline
Surgery and Emdogain®	Emdogain®	access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline

Primary Outcome Measures

Name	Time	Method
Changes in marginal bone level at dental implant	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sweden; 🇸🇪 Gävle, Sweden