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

NCT06137846 | Completed

• 1 other identifier: HUM00164918
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (2)

• Inflammatory cytokines levels

  Baseline, 2 weeks, 4 weeks, 3 months, and 6 months

• Bacterial DNA levels

  Baseline, 2 weeks, 4 weeks, 3 months, and 6 months

Study Arms (2)

Peri-mucositis

EXPERIMENTAL

Dental implant has peri-implant mucositis

Device: Air-Polish; Device: Ultrasonic

Healthy

PLACEBO COMPARATOR

Dental implant does not have peri-implant mucositis

Device: Air-Polish

Interventions

Air-Polish DEVICE

Dental implant will be cleaned with an airpolishing device

Healthy; Peri-mucositis

Ultrasonic DEVICE

Dental implant will be cleaned with an ultrasonic device with a plastic tip

Peri-mucositis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hom-Lay Wang, DDS MSD PhD

  Department of Periodontics and Oral Medicine University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: October 31, 2023
• Primary Completion: March 19, 2025
• Study Completion: June 20, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (1)