Ten Years Follow up of Peri-implant Surgery

February 2, 2020 updated by: Giovanni Serino, Public Dental Service, Specialist Clinics, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Borås, Sweden, 50182
        • Giovanni Serino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who had received routine surgical treatment of peri-implantitis between 2007 and 2009 and thereafter enrolled in supportive peri-implant treatment (SPT)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number patients with persisting peri-implantitis following peri-implant surgery
Time Frame: 10 years

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
Percentage of subjects with persisting peri-implantitis
Time Frame: 10 years

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
Number of implant with persisting peri-implantitis
Time Frame: 10 years

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
Percentage of implants wih persisting peri-implantitis
Time Frame: 10 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessement of risk factors related to the persistence of peri-implantitis
Time Frame: 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Dental Service, Specialist Clinics, Sweden

Collaborators

Osaka University Japan

Investigators

  • Principal Investigator: Giovanni Serino, DDS PhD, Folktanvarden Specilist Clinic Periodntology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDSSweden

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After publication, on request, summary data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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