Regenerative Surgical Treatment of Peri-implantitis

August 31, 2016 updated by: Catrine Isehed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gävle, Sweden
        • Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in marginal bone level at dental implant
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catrine Isehed

Collaborators

Umeå University

Investigators

  • Principal Investigator: Pernilla Lundberg, Assoc. Prof, Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, pernilla.lundberg@umu.se

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFUG 476871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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