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

Peri-implant Mucositis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06137846
• Other study ID #: HUM00164918
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Device:
• Air-Polish
Dental implant will be cleaned with an airpolishing device
• Ultrasonic
Dental implant will be cleaned with an ultrasonic device with a plastic tip

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth measurements	To compare probing depth measurements in millimeters after non-surgical treatment of peri-implant mucositis	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Primary	Bleeding on probing scores (Mombelli et al.)	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.	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Primary	Plaque score (Loe & Silness)	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.	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Primary	Gingival index (Loe & Silness)	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.	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Primary	Gum recession measurement	To compare gum recession after non-surgical treatment of peri-implant mucositis	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Primary	Bone measurement	Loss of supporting bone measured by standardized radiographs	Baseline, 3 months, and 6 months
Secondary	Inflammatory cytokines levels	To compare changes in the level of inflammatory cytokines in peri-implant crevicular fluid (PICF)	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Secondary	Bacterial DNA levels	To compare changes in the level of bacterial DNA of Aa, Pg, Pi, Tf, and Td in PICF	Baseline, 2 weeks, 4 weeks, 3 months, and 6 months