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Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.

Primary Purpose

Peri-Implantitis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Non-surgical treatment of peri-implantitis with mechanical debridement
Non-surgical treatment of peri-implantitis with air polishing
Sponsored by
Tannhelsetjenestens Kompetansesenter for Nord-Norge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implantitis, Non-surgical treatment, Air-polishing, Mechanical debridement, Bleeding on probing, periodontal pocket depth

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tannhelsetjenestens kompetansesenter for Nord-NorgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mechanical debridement

Air polishing

Arm Description

Outcomes

Primary Outcome Measures

Probing depth
Probing depth 5 millimeters or more
Bleeding on probing
Bleeding from pocket on pocket depth probing
Suppuration on probing
Suppuration from pocket on pocket depth probing

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
May 30, 2023
Sponsor
Tannhelsetjenestens Kompetansesenter for Nord-Norge
Collaborators
Malmö University
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1. Study Identification

Unique Protocol Identification Number
NCT05683405
Brief Title
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.
Official Title
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tannhelsetjenestens Kompetansesenter for Nord-Norge
Collaborators
Malmö University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-implantitis, Non-surgical treatment, Air-polishing, Mechanical debridement, Bleeding on probing, periodontal pocket depth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.
Masking
Outcomes Assessor
Masking Description
A periodontist that is not involved in the treatment and who is blinded to the treatment received will evaluate the treatment results.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mechanical debridement
Arm Type
Experimental
Arm Title
Air polishing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Non-surgical treatment of peri-implantitis with mechanical debridement
Intervention Description
Non-surgical treatment of peri-implantitis with mechanical debridement .
Intervention Type
Procedure
Intervention Name(s)
Non-surgical treatment of peri-implantitis with air polishing
Intervention Description
Non-surgical treatment of peri-implantitis with air polishing
Primary Outcome Measure Information:
Title
Probing depth
Description
Probing depth 5 millimeters or more
Time Frame
26 weeks
Title
Bleeding on probing
Description
Bleeding from pocket on pocket depth probing
Time Frame
26 weeks
Title
Suppuration on probing
Description
Suppuration from pocket on pocket depth probing
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elin Hadler-Olsen, PhD
Phone
+47 48 06 72 49
Email
elin.hadlerolsen@tffk.no
Facility Information:
Facility Name
Tannhelsetjenestens kompetansesenter for Nord-Norge
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9271
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elin Hadler-Olsen
Phone
+4748067249
Email
elin.hadlerolsen@tffk.no

12. IPD Sharing Statement

Learn more about this trial

Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.

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