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NCT Number: NCT04254406

Ten Years Follow up of Peri-implant Surgery

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Giovanni Serino

Borås, 50182, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Descriptive study

Other

Evaluation of routine treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Public Dental Service, Specialist Clinics, Sweden

Other

Collaborators

  • Osaka University Japan

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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