Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy
- Conditions
- Peri-implant Mucositis
- Interventions
- Device: Air-PolishDevice: Ultrasonic
- Registration Number
- NCT06137846
- Lead Sponsor
- University of Michigan
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peri-mucositis Ultrasonic Dental implant has peri-implant mucositis Peri-mucositis Air-Polish Dental implant has peri-implant mucositis Healthy Air-Polish Dental implant does not have peri-implant mucositis
- Primary Outcome Measures
Name Time Method Plaque score (Loe & Silness) Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare plaque scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater plaque accumulation.
Probing depth measurements Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare probing depth measurements in millimeters after non-surgical treatment of peri-implant mucositis
Gum recession measurement Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare gum recession after non-surgical treatment of peri-implant mucositis
Bleeding on probing scores (Mombelli et al.) Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare bleeding on probing after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating heavier bleeding.
Gingival index (Loe & Silness) Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare gingival index scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater inflammation.
Bone measurement Baseline, 3 months, and 6 months Loss of supporting bone measured by standardized radiographs
- Secondary Outcome Measures
Name Time Method Inflammatory cytokines levels Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare changes in the level of inflammatory cytokines in peri-implant crevicular fluid (PICF)
Bacterial DNA levels Baseline, 2 weeks, 4 weeks, 3 months, and 6 months To compare changes in the level of bacterial DNA of Aa, Pg, Pi, Tf, and Td in PICF
Trial Locations
- Locations (1)
University of Michigan School of Dentistry
🇺🇸Ann Arbor, Michigan, United States