Regenerative Surgical Treatment of Peri-implantitis

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500654
• Other study ID #: CFUG 476871
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2015
• Last updated: August 31, 2016
• Start date: December 2008
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Region Gävleborg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Bleeding of Subgingival Space
• Communicable Diseases
• Failure of Dental Implant Due to Infection
• Gingival Diseases
• Infection
• Inflammation
• Molecular Sequence Variation
• Mouth Diseases
• Peri-Implantitis
• Periodontal Diseases

Intervention

Device:
• Emdogain®
Surgery and Emdogain®
• Surgery alone
Surgery alone

Locations

Country	Name	City	State
Sweden	Sweden	Gävle

Sponsors (2)

Lead Sponsor	Collaborator
Catrine Isehed	Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Holmlund A, Hänström 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in marginal bone level at dental implant		12 months	Yes
Secondary	Changes in peri-implant microflora incidence and composition		2weeks, 3, 6, 12 months	Yes
Secondary	Changes in peri-implant pocket depth		12 months	Yes
Secondary	Number of sites with bleeding on probing		3,6, 9, 12 months	Yes
Secondary	Number of sites with bacterial plaque at the implant		3,6, 9, 12 months	Yes
Secondary	Number of sites with suppuration on probing		3,6, 9, 12 months	Yes
Secondary	Number of sites with marginal gingival recession		3,6, 9, 12 months	Yes
Secondary	Full mouth plaque score		3,6, 9, 12 months	Yes
Secondary	Full mouth bleeding score		3,6, 9, 12 months	Yes