NCT05664425

Mechanical Treatment Peri-Implant Mucositis

Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
DEVICE	Ultrasonic debridement	Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2022-12-23
• Last updated: 2025-03-07

Locations

1 site across 1 country: Norway