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

NCT ID: NCT06137846

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-06-20

Brief Summary

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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

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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.

Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Peri-mucositis

Dental implant has peri-implant mucositis

Group Type EXPERIMENTAL

Air-Polish

Intervention Type DEVICE

Dental implant will be cleaned with an airpolishing device

Ultrasonic

Intervention Type DEVICE

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

Healthy

Dental implant does not have peri-implant mucositis

Group Type PLACEBO_COMPARATOR

Air-Polish

Intervention Type DEVICE

Dental implant will be cleaned with an airpolishing device

Interventions

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Air-Polish

Dental implant will be cleaned with an airpolishing device

Intervention Type DEVICE

Ultrasonic

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Hom-Lay Wang, DDS, MSD, Ph D

Collegiate Professor of Periodontics and Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hom-Lay Wang, DDS MSD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Periodontics and Oral Medicine University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00164918

Identifier Type: -

Identifier Source: org_study_id

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