Clinical trial NCT02500654: Regenerative Surgical Treatment of Peri-implantitis
Official title: Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2015-07-16
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in marginal bone level at dental implant
timeFrame: 12 months
Secondary outcomes:
measure: Changes in peri-implant microflora incidence and composition
timeFrame: 2weeks, 3, 6, 12 months
measure: Changes in peri-implant pocket depth
timeFrame: 12 months
measure: Number of sites with bleeding on probing
timeFrame: 3,6, 9, 12 months
measure: Number of sites with bacterial plaque at the implant
timeFrame: 3,6, 9, 12 months
measure: Number of sites with suppuration on probing
timeFrame: 3,6, 9, 12 months
measure: Number of sites with marginal gingival recession
timeFrame: 3,6, 9, 12 months
measure: Full mouth plaque score
timeFrame: 3,6, 9, 12 months
measure: Full mouth bleeding score
timeFrame: 3,6, 9, 12 months
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Sweden
Study officials:
affiliation: Department of Odontology, Division of Molecular Periodontology , Umeå University, Sweden, pernilla.lundberg@umu.se
name: Pernilla Lundberg, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.