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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05683405
Other study ID # 343997
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 2028

Study information

Verified date May 2023
Source Tannhelsetjenestens Kompetansesenter for Nord-Norge
Contact Elin Hadler-Olsen, PhD
Phone +47 48 06 72 49
Email elin.hadlerolsen@tffk.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is: • Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments? Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise. Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date December 2028
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis - Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting. Exclusion Criteria: - Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Non-surgical treatment of peri-implantitis with mechanical debridement
Non-surgical treatment of peri-implantitis with mechanical debridement .
Non-surgical treatment of peri-implantitis with air polishing
Non-surgical treatment of peri-implantitis with air polishing

Locations

Country Name City State
Norway Tannhelsetjenestens kompetansesenter for Nord-Norge Tromsø Troms

Sponsors (2)

Lead Sponsor Collaborator
Tannhelsetjenestens Kompetansesenter for Nord-Norge Malmö University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Probing depth Probing depth 5 millimeters or more 26 weeks
Primary Bleeding on probing Bleeding from pocket on pocket depth probing 26 weeks
Primary Suppuration on probing Suppuration from pocket on pocket depth probing 26 weeks
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