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

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

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.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Device: Air-Polish; Device: Ultrasonic

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peri-mucositis; Dental implant has peri-implant mucositis	Device: Air-Polish; Dental implant will be cleaned with an airpolishing device; Device: Ultrasonic; Dental implant will be cleaned with an ultrasonic device with a plastic tip
Placebo Comparator: Healthy; Dental implant does not have peri-implant mucositis	Device: Air-Polish; Dental implant will be cleaned with an airpolishing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Bone measurement	Loss of supporting bone measured by standardized radiographs	Baseline, 3 months, and 6 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Mucositis
• Other Study ID Numbers: HUM00164918

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No