Follow-Up After Surgical Treatment of Peri-implantitis

December 19, 2016 updated by: Göteborg University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

100

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients who received surgical treatment for peri-implantitis during the RCT registered in ClinicalTrials.gov NCT NCT01857804

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3 years follow-up
all patients who received surgical treatment for peri-implantitis during a Randomized and Controlled Trial registered in ClinicalTrials.gov NCT NCT01857804
Procedure: 3 years follow-up
Examination 3 years after surgical treatment of peri-implantitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in treatment success at 3 years post-op
Time Frame: baseline (1 year post-op) and 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

Collaborators and Investigators

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

Sponsor

Göteborg University

Investigators

  • Study Chair: Tord Berglundh, Professor, Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg

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

December 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • olivier2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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