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

NCT05683405 | Recruiting DMC

• 1 other identifier: 343997
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

Peri-implantitis; Non-surgical treatment; Air-polishing; Mechanical debridement; Bleeding on probing; periodontal pocket depth

Outcome Measures

Primary Outcomes (3)

• Probing depth

  Probing depth 5 millimeters or more

  26 weeks

• Bleeding on probing

  Bleeding from pocket on pocket depth probing

  26 weeks

• Suppuration on probing

  Suppuration from pocket on pocket depth probing

  26 weeks

Study Arms (2)

Mechanical debridement

EXPERIMENTAL

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

Air polishing

EXPERIMENTAL

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

Interventions

Non-surgical treatment of peri-implantitis with mechanical debridement PROCEDURE

Non-surgical treatment of peri-implantitis with mechanical debridement .

Mechanical debridement

Non-surgical treatment of peri-implantitis with air polishing PROCEDURE

Non-surgical treatment of peri-implantitis with air polishing

Air polishing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tannhelsetjenestens Kompetansesenter for Nord-Norge: lead
• Malmö University: collaborator

Study Sites (1)

Tannhelsetjenestens kompetansesenter for Nord-Norge

Tromsø, Troms, 9271, Norway

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Elin Hadler-Olsen, PhD

CONTACT

+47 48 06 72 49; elin.hadlerolsen@tffk.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A periodontist that is not involved in the treatment and who is blinded to the treatment received will evaluate the treatment results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

NO (1)