Ten Years Follow up of Peri-implant Surgery

Peri-Implantitis Clinical Trial

Official title:

10 Years Follow-up of Patients With Residual Pockets Following the Surgical Treatment of Peri-implantitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254406
• Other study ID #: PDSSweden
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2020
• Source: Public Dental Service, Specialist Clinics, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To report 10-years follow up of patients following the surgical treatment of peri-implantitis and to identify possible risk indicators for the progression of disease during supportive peri-implant therapy.

Description:

The data for this retrospective clinical evaluation were collected from the files and radiographs of consecutive patients who had received surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT) .

Between 2007 and 2009, 41 patients with at least 1 implant with peri-implantitis that underwent peri-implant surgery were enrolled in a supportive peri-implant therapy.

At the 2-years follow up, two groups could be identified, one "responding group" (17 patients) who did not present any implants with peri-implantitis and a "no-responding Group" (22 patients), presenting still peri-implantitis.

Following the 2-years control visit, 17 patients of the responding group exited the supporting peri-implant therapy at the specialist clinic. They continued the routine controls at their referral clinics while the 22 patients of the no-responding group, continued the scheduled supportive peri-implant therapy (SPT) given at the specialist clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients treated with peri-implantitis surgery between 2007 and 2009 using an anti-infective protocol.

Exclusion Criteria:

• Patients treated with peri-implantitis surgery between 2007 and 2009 using a regenerative protocol at one single implants with peri-implantitis.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• Descriptive study
Evaluation of routine treatment

Locations

Country	Name	City	State
Sweden	Giovanni Serino	Borås

Sponsors (2)

Lead Sponsor	Collaborator
Public Dental Service, Specialist Clinics, Sweden	Osaka University Japan

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, To — View Citation

Heitz-Mayfield LJA, 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. 2018 Jan;29(1):1-6. doi: 10.1 — View Citation

Lagervall M, Jansson LE. Treatment outcome in patients with peri-implantitis in a periodontal clinic: a retrospective study. J Periodontol. 2013 Oct;84(10):1365-73. doi: 10.1902/jop.2012.120555. Epub 2012 Dec 13. — View Citation

Pjetursson BE, Helbling C, Weber HP, Matuliene G, Salvi GE, Brägger U, Schmidlin K, Zwahlen M, Lang NP. Peri-implantitis susceptibility as it relates to periodontal therapy and supportive care. Clin Oral Implants Res. 2012 Jul;23(7):888-94. doi: 10.1111/j — View Citation

Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287. — 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):950-956. doi: 10.1111/clr.12418. Epub 2014 May 26. — 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. Epub 2011 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number patients with persisting peri-implantitis following peri-implant surgery	The total number of patients with persisting peri-implantitis will be calculated. Any subject presenting at least one implants with a pathological pocket will be regarded as positive for the disease .; The presence or absence of peri-implantitis will be assessed by using a periodontal probe around the mucosa of the implants.; The definition of a pathological pocket around an implant is a pocket of 5 millimeters or more deep with concomitants bleeding after the use of the probe.	10 years
Primary	Percentage of subjects with persisting peri-implantitis	The percentage of patients with persisting peri-implantitis following peri-implantitis surgery will be calculated among all the patients that were treated.; For definition of peri-implantitis see description at outcome 1.	10 years
Primary	Number of implant with persisting peri-implantitis	The number of implants with persisting clinical signs of peri-implantitis will be calculated. Any implant presenting a pathological pockets around its surface will be regarded as positive for the disease.; For definition of peri-implantitis see description at outcome 1	10 years
Primary	Percentage of implants wih persisting peri-implantitis	The percentage of implants with persisting peri-implantitis after surgery will be calculated among all the implants that were surgically treated.; For definition of peri-implantitis see description at outcome 1	10 years
Secondary	Assessement of risk factors related to the persistence of peri-implantitis	A univariate logistic regression to assess the correlations between each independent variable and the binary outcome presence or absence of peri-implantitis at treated implants will be used. Then, a multivariable regression analysis will be use including the independent variables from the univariate analysis that reach a statistical significance after adjusting for gender and age.	10 years