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SPiT-frequency I_Peri-implant Mucositis

NCT06737328 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-17

No results posted yet for this study

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 SPiT (supportive peri-implant treatment) protocol on implants diagnosed with peri-implant mucositis.

The study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis. The other study is a RCT on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface) (REK 790240). 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

Interventions

PROCEDURE

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

The treatment under study is professional non-surgical, submucosal debridement with ultrasonic instruments with PolyEther Ether Ketone (PEEK) tip followed by copious irrigation with sterile saline

Sponsors & Collaborators

  • University of Oslo

    lead OTHER

Principal Investigators

  • Carl Hjortsjø, Ph.D · Institute for Clinical Dentistry, Dental Faculty, University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-19
Completion
2028-01-19

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737328 on ClinicalTrials.gov