Follow-Up After Surgical Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Follow-Up After Surgical Treatment of Peri-implantitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860208
• Other study ID #: olivier2
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: December 19, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.

Description:

The patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, Molndal and Gothenburg, Public Dental Health Services, Region Vastra Gotaland, Sweden) and were enrolled between October 2010 and December 2013.). All were treated by experienced periodontists.

Details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at ClinicalTrials.gov (NCT01857804) and approved by the Regional Ethical Committee, Gothenburg, Sweden (Dnr. 654-10).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients who received surgical treatment for peri-implantitis for 3 years ago

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• 3 years follow-up
Examination 3 years after surgical treatment of peri-implantitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

References & Publications (6)

Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennström J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. — View Citation

Heitz-Mayfield LJ, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2016 Jun 23. doi: 10.1111/clr.12910. [Epub ahead of print] — View Citation

Mettraux GR, Sculean A, Bürgin WB, Salvi GE. Two-year clinical outcomes following non-surgical mechanical therapy of peri-implantitis with adjunctive diode laser application. Clin Oral Implants Res. 2016 Jul;27(7):845-9. doi: 10.1111/clr.12689. — View Citation

Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology.. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x. — View Citation

Serino G, Turri A, Lang NP. Maintenance therapy in patients following the surgical treatment of peri-implantitis: a 5-year follow-up study. Clin Oral Implants Res. 2015 Aug;26(8):950-6. doi: 10.1111/clr.12418. — View Citation

Serino G, Turri A. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans. Clin Oral Implants Res. 2011 Nov;22(11):1214-20. doi: 10.1111/j.1600-0501.2010.02098.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in treatment success at 3 years post-op	treatment success is defined by pocket closure, no bleeding on probing, bone loss =0.5 mm between baseline and 3 years	baseline (1 year post-op) and 3 years post-op	No