Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

Peri-Implantitis Clinical Trial

Official title:

Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339789
• Other study ID #: 2020-01019
• Status: Recruiting
• Start date: August 30, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Malmö University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The surgical treatment outcome of patients that have been or are consecutively treated at the University of Malmö, at Blekinge hospital, and at the Dental Clinic of the Sigmund Freud University Vienna will be evaluated on an a regular base; specifically all patients treated since 2014 and those receiving treatment in the future, will be regularly assessed, max. once per year after the 1-year control from the surgical intervention for clinical and radiographic assessment of healing. Clinical peri-implant parameters (e.g., probing pocket depth) and peri-implant sulcus fluid (PISF) are collected, and a peri-apical radiographic examination is made. Further, from 200 patients treated in the future, the inflammatory peri-implant lesion will be collected and subjected to histological, microbiological, and molecular analysis. The removal of these lesions is a standard procedure and performed in all patients independent of study participation; i.e., the lesion has anyway to be removed during surgery and if the lesions are not stored, they would be thrown.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• All patients being treated since 2014 and continuously being treated will be called in for regular check-ups after the surgical intervention and an examination for study purpose will be performed annually.

Exclusion criteria:

• implant loss

Related Conditions & MeSH terms

• Peri-Implantitis

Locations

Country	Name	City	State
Austria	Dental Clinic, Sigmund Freud University Vienna	Vienna
Sweden	Blekinge hospital	Karlskrona
Sweden	Malmö University	Malmö

Sponsors (4)

Lead Sponsor	Collaborator
Malmö University	Blekinge County Council Hospital, Medical University of Vienna, Sigmund Freud PrivatUniversitat

Countries where clinical trial is conducted

Austria,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	12 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	24 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	36 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	48 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	60 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	72 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	84 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	96 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	108 months postoperative
Primary	Disease resolution (Binary: yes/no)	Disease resolution will be defined as peri-implant probing pocket depth = 5 mm and no excessive bleeding and/or suppuration on probing.	120 months postoperative