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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02500654
Enrollment
31
Registered
2015-07-16
Start date
2008-12-31
Completion date
2014-01-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Peri-implantitis, Regenerative therapy, Surgical therapy, Enamel matrix derivative, Peri-implant microflora, Peri-implant fluid

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.

Interventions

DEVICEEmdogain®

Surgery and Emdogain®

Surgery alone

Sponsors

Umeå University
CollaboratorOTHER
Catrine Isehed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in marginal bone level at dental implant12 months

Secondary

MeasureTime frame
Changes in peri-implant microflora incidence and composition2weeks, 3, 6, 12 months
Changes in peri-implant pocket depth12 months
Number of sites with bleeding on probing3,6, 9, 12 months
Number of sites with bacterial plaque at the implant3,6, 9, 12 months
Number of sites with suppuration on probing3,6, 9, 12 months
Number of sites with marginal gingival recession3,6, 9, 12 months
Full mouth plaque score3,6, 9, 12 months
Full mouth bleeding score3,6, 9, 12 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026