SPiT-frequency II_Peri-implantitis

NCT06737315 | Not Yet Recruiting

• 2 other identifiers: SPiT-frequency II_Peri-implantREK790240
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional clinical study on the peri-implant treatment necessary to improve the clinical conditions surrounding dental implants registered with peri-implant inflammation. The focus of this double-armed, examiner blinded, controlled, randomized clinical trial is to examine the effect of short-term increased frequency of a Non-surgical protocol on implants diagnosed with peri-implantitis. The study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface). The other study is a RCT on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis (REK 790097). Exposure of rough surface may dramatically change the frequency of maintenance needed to improve the inflammatory condition. Thus, a segregation between adequate and low bone level at the implant is necessary. Subjects with more than one implant and both diagnoses, may be enrolled in both studies, following the frequency of treatment randomized in the peri-implant mucositis study

Conditions

Peri-Implantitis and Peri-implant Mucositis

Keywords

Peri-implantitis; Non-surgical treatment; Frequency

Outcome Measures

Primary Outcomes (1)

• Peri-implant inflammation

  To assess the proportion of implants without signs of inflammation (eradication of disease). Inflammation is defined as Bleeding on Probing (BoP) and/or suppuration

  From baseline to 9 months

Secondary Outcomes (1)

• Improvement of inflammation severity

  From baseline to 9 months

Other Outcomes (8)

• Extent of inflammation

  Baseline to 9 months

• Reduction of pocket probing depths

  Baseline to 9 months

• Buccal keratinized mucosa

  Baseline to 9 months

Study Arms (2)

Test. Increased treatment frequency

EXPERIMENTAL

Submucosal instrumentation will be performed at baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 16 weeks, 24 weeks and 36 weeks

Procedure: Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning

Control. Conventional frequency

ACTIVE COMPARATOR

Submucosal instrumentation will be performed at baseline, 12 weeks, 24 weeks and 36 weeks

Procedure: Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning

Interventions

Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning PROCEDURE

The treatment under study is professional non-surgical, submucosal debridement with ultrasonic instruments with PolyEther Ether Ketone (PEEK)

Control. Conventional frequency; Test. Increased treatment frequency

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subject must be ≥ 20 years, diagnosed with peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018) with a bone level \> 3 mm from the expected initial bone level Peri-implantitis: Bleeding after gentle probing at an implant and radiographic bone level \> 3 mm

You may not qualify if:

• \- Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.
• No pregnant or nursing subjects.
• \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.
• HIV positive or other disease severely affecting the immune system
• If examiners/operators agree the placement of the implant (angle, position, proximity to adjacent implant or tooth) or suprastructure was suboptimal and considered to play a major role in the development of inflammation.
• Anatomical abnormalities.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Faculty of Dentistry, University of Oslo

Oslo, 0455, Norway

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Carl Hjortsjø, Ph.D

  Institute for Clinical Dentistry, Dental Faculty, University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odd Carsten Koldsland, Ph.D

CONTACT

+47 93098618; oddcko@odont.uio.no

Anders Verket, Ph.D

CONTACT

004793667661; anderver@odont.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 19, 2027
• Study Completion (Estimated): January 19, 2028
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Central Contact person and corresponding author of publication

Locations

NO (1)