Clinical trial NCT06137846: Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Age 18 to 85 years.
2. 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).
3. 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.
4. Have a current (less than 6 months old) x-ray of the affected site
5. All participants must be enrolled in a 3 to 6 months maintenance recall program including teeth/implants prophylaxis and supportive periodontal therapy.

Exclusion criteria:

1. Poorly controlled diabetes mellitus (HbA1c \>6.5).
2. Uncontrolled systemic disease or condition known to alter bone metabolism. (e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease)
3. Current smokers or vapers.
4. Pregnancy or could be pregnant (self-reported), or plan to be pregnant in the next 6 months.
5. 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.
6. Taking corticosteroids.
7. Long-term antibiotic use (\> one weeks) within three months previous to participation in the study.
8. No history of supragingival scaling or non-surgical therapy at the affected implant site in the last 1 month.
9. Taking anticoagulant medications.
10. Subjects who require prophylactic antibiotics.

Primary outcomes:
measure: Probing depth measurements
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Bleeding on probing scores (Mombelli et al.)
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Plaque score (Loe & Silness)
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Gingival index (Loe & Silness)
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Gum recession measurement
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Bone measurement
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Inflammatory cytokines levels
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
measure: Bacterial DNA levels
timeFrame: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References: