Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy

Completed · Not applicable

Conditions studied: Peri-implant Mucositis

In brief

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.

Key facts

Study ID

NCT06137846

Run by

University of Michigan

People needed

52

Starts

2023-10-31

Expected to finish

2025-06-20

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 to 85 years.
• Healthy systemic conditions (American Society of Anesthesiologists classification (ASA) I or II: systemically healthy or suffer from mild to moderate, but well controlled systemic diseases).
• Must have at least one osseointegrated dental implant with the following conditions (Berglundh et al. 2018a).
• At least 12 months since the prosthesis was placed.
• Absence of bone loss beyond crestal bone level changes from initial bone remodeling.
• For implant mucositis subjects: Presence of bleeding and/or suppuration on gentle probing around implant at least 2 sites. Visual inspection demonstrating the presence of peri-implant signs of inflammation.
• For healthy implant subjects: Absence of bleeding and/or suppuration on gentle probing around implant.
• Have a current (less than 6 months old) x-ray of the affected site
• All participants must be enrolled in a 3 to 6 months maintenance recall program including teeth/implants prophylaxis and supportive periodontal therapy.

You may not qualify if…

• Poorly controlled diabetes mellitus (HbA1c >6.5).
• Uncontrolled systemic disease or condition known to alter bone metabolism. (e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease)
• Current smokers or vapers.
• Pregnancy or could be pregnant (self-reported), or plan to be pregnant in the next 6 months.
• Long-term (3 months) intake of anti-inflammatory medications (e.g. non-steroidal anti-inflammatory drugs (NSAIDs)) known to affect periodontal status within one month previous to participation in the study.
• Taking corticosteroids.
• Long-term antibiotic use (> one weeks) within three months previous to participation in the study.
• No history of supragingival scaling or non-surgical therapy at the affected implant site in the last 1 month.
• Taking anticoagulant medications.
• Subjects who require prophylactic antibiotics.

Where it is running

• University of Michigan School of Dentistry — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.