Regenerative Surgical Treatment of Peri-implantitis

NCT02500654 | Completed Phase 4

• 1 other identifier: CFUG 476871
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in marginal bone level at dental implant

  12 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Surgery and Emdogain®

EXPERIMENTAL

access peri-implant surgery with Emdogain® applied after cleaning of implant surface with saline

Device: Emdogain®

Surgery alone

PLACEBO COMPARATOR

access peri-implant surgery and cleaning of implant surface with saline

Device: Surgery alone

Interventions

Emdogain® DEVICE

Surgery and Emdogain®

Also known as: enamel matrix derivative, enamel matrix proteins

Surgery and Emdogain®

Surgery alone DEVICE

Surgery alone

Surgery alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• peri-implant angular bone loss ≥3 mm, measured at radiographs
• deep pocket ≥5 mm combined with bleeding and/or pus

You may not qualify if:

• 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

Sponsors & Collaborators

• Catrine Isehed: lead
• Umeå University: collaborator

Study Sites (1)

Sweden

Gävle, Sweden

Location

Related Publications (9)

• Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.

  PMID: 25495683 BACKGROUND

• Heitz-Mayfield LJ, Lang NP. Comparative biology of chronic and aggressive periodontitis vs. peri-implantitis. Periodontol 2000. 2010 Jun;53:167-81. doi: 10.1111/j.1600-0757.2010.00348.x.

  PMID: 20403112 BACKGROUND

• Maruyama N, Maruyama F, Takeuchi Y, Aikawa C, Izumi Y, Nakagawa I. Intraindividual variation in core microbiota in peri-implantitis and periodontitis. Sci Rep. 2014 Oct 13;4:6602. doi: 10.1038/srep06602.

  PMID: 25308100 BACKGROUND

• Basegmez C, Yalcin S, Yalcin F, Ersanli S, Mijiritsky E. Evaluation of periimplant crevicular fluid prostaglandin E2 and matrix metalloproteinase-8 levels from health to periimplant disease status: a prospective study. Implant Dent. 2012 Aug;21(4):306-10. doi: 10.1097/ID.0b013e3182588408.

  PMID: 22814555 BACKGROUND

• Carcuac O, Berglundh T. Composition of human peri-implantitis and periodontitis lesions. J Dent Res. 2014 Nov;93(11):1083-8. doi: 10.1177/0022034514551754. Epub 2014 Sep 26.

  PMID: 25261052 BACKGROUND

• Holmlund A, Hanstrom L, Lerner UH. Bone resorbing activity and cytokine levels in gingival crevicular fluid before and after treatment of periodontal disease. J Clin Periodontol. 2004 Jun;31(6):475-82. doi: 10.1111/j.1600-051X.2004.00504.x.

  PMID: 15142219 BACKGROUND

• Bosshardt DD. Biological mediators and periodontal regeneration: a review of enamel matrix proteins at the cellular and molecular levels. J Clin Periodontol. 2008 Sep;35(8 Suppl):87-105. doi: 10.1111/j.1600-051X.2008.01264.x.

  PMID: 18724844 BACKGROUND

• Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.

  PMID: 22834392 BACKGROUND

• Casati MZ, Sallum EA, Nociti FH Jr, Caffesse RG, Sallum AW. Enamel matrix derivative and bone healing after guided bone regeneration in dehiscence-type defects around implants. A histomorphometric study in dogs. J Periodontol. 2002 Jul;73(7):789-96. doi: 10.1902/jop.2002.73.7.789.

  PMID: 12146539 BACKGROUND

MeSH Terms

Conditions

Infections; Inflammation; Peri-Implantitis; Bacterial Infections; Periodontal Diseases; Mouth Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases; Bacterial Infections and Mycoses

Study Officials

• Pernilla Lundberg, Assoc. Prof

  Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, pernilla.lundberg@umu.se

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, periodontist

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 16, 2015
• Study Start: December 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)