University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06137846
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dental implant will be cleaned with an airpolishing device
Dental implant will be cleaned with an ultrasonic device with a plastic tip
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
To compare gum recession after non-surgical treatment of peri-implant mucositis
Time frame: Baseline, 3 months, and 6 months
Loss of supporting bone measured by standardized radiographs
Time frame: 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)
Time frame: 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
University of Michigan
Other
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
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