Trials / Completed
CompletedNCT06137846
Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy
Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy Using an Erythritol Air- Polishing Device Versus Conventional Mechanical Debridement: A 6-month Randomized Controlled Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. The investigators wish to compare the amount of inflammation and bacteria through measurements (like probing depth) and by collecting fluid and plaque samples around participants' implant after using one of the two cleaning instruments.
Detailed description
Despite the potential benefits of an air-polishing device with erythritol powder, clinical trials using the device as a monotherapy for treating patients with peri-implant mucositis remained limited. Therefore, the primary aim of the present study is to compare clinical outcomes of the non-surgical treatment of peri-implant mucositis and subsequent supportive peri-implant therapy (SPIT) using an erythritol air-polishing device or conventional mechanical debridement. The secondary aim is to compare the resolution of inflammation after non-surgical treatment of peri-implant mucositis and to monitor levels of peri-implant tissues inflammation during supportive peri-implant therapy by using the level of selected pro-inflammatory cytokines. Up to 60 participants with dental implants will be recruited from patients seeking and/or receiving dental care at the University of Michigan Graduate Periodontics department, until 34 peri-mucositis participants and 17 healthy participants are achieved.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Air-Polish | Dental implant will be cleaned with an airpolishing device |
| DEVICE | Ultrasonic | Dental implant will be cleaned with an ultrasonic device with a plastic tip |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2025-03-19
- Completion
- 2025-06-20
- First posted
- 2023-11-18
- Last updated
- 2025-08-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06137846. Inclusion in this directory is not an endorsement.