Air-Polishing vs Ultrasonic Treatment for Gum Inflammation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: NSAIDs, Corticosteroids, Antibiotics, Anticoagulants

Disqualifiers: Diabetes, Osteoporosis, Smoking, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 6 months

60 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as long-term anti-inflammatory drugs, corticosteroids, long-term antibiotics, and anticoagulants, before participating. If you are on any of these, you may need to stop them to join the study.

What data supports the effectiveness of the treatment Air-Polish and Ultrasonic for gum inflammation?

Research shows that both air polishing and ultrasonic treatments can effectively reduce gum inflammation and improve gum health. Studies have found that these treatments help remove harmful bacteria and improve gum attachment, making them suitable for managing gum disease. ^{1 2 3 4 5}

Is air polishing and ultrasonic treatment safe for humans?

Research shows that air polishing and ultrasonic treatments are generally safe for humans, with no significant harmful effects on dental restorations or periodontal health observed in studies. ^{1 3 4 5 6}

How does the air-polishing and ultrasonic treatment for gum inflammation differ from other treatments?

Air-polishing and ultrasonic treatment for gum inflammation is unique because it uses a combination of air polishing with erythritol powder and ultrasonic scaling to effectively reduce gum inflammation and improve gum health. This approach is different from traditional methods as it focuses on both supra- and subgingival biofilm removal, which can lead to better long-term periodontal care. ^{1 4 5 7 8}

Research Team

Hom-Lay Wang, DDS MSD PhD

Principal Investigator

Department of Periodontics and Oral Medicine University of Michigan

Eligibility Criteria

This trial is for adults aged 18-85 with good overall health and a dental implant that's been in place for over a year. They must show signs of gum inflammation around the implant but no bone loss, or have healthy implants as part of regular dental care. Excluded are those with poorly controlled diabetes, certain systemic diseases, smokers, pregnant women, long-term users of anti-inflammatories or antibiotics, and those on anticoagulants.

Inclusion Criteria

I have a dental implant that's been in place for over a year and it's either healthy or shows signs of gum inflammation.

I am enrolled in a dental care program for the next 3-6 months.

Have a current (less than 6 months old) x-ray of the affected site

Exclusion Criteria

I am currently taking blood thinner medications.

My diabetes is not well-managed (HbA1c >6.5).

I do not have diseases like osteoporosis that affect bone health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Non-surgical treatment of peri-implant mucositis using an erythritol air-polishing device or conventional mechanical debridement

6 months

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

Supportive Peri-implant Therapy (SPIT)

Monitoring levels of peri-implant tissues inflammation and supportive therapy

6 months

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

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Air-Polish
• Ultrasonic

Trial Overview The study compares two cleaning methods—Air-Polish and Ultrasonic—for treating gum inflammation around dental implants (peri-implant mucositis). Researchers will assess changes in inflammation and bacteria levels by measuring probing depth and analyzing fluid and plaque from around the implant.

Participant Groups

Group I: Peri-mucositis Experimental Treatment 2 Interventions

Dental implant has peri-implant mucositis

Group II: Healthy Placebo Group 1 Intervention

Dental implant does not have peri-implant mucositis

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Infection Control in Adult Periodontal Patients Using Ultrasonic Debridement and Erythritol Powder: A Randomized, Controlled, Split-Mouth Clinical Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical, inflammatory and microbiological outcomes of full-mouth scaling with adjunctive glycine powder air-polishing: A randomized trial. [2021]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical observation of glycine powder air-polishing during periodontal maintenance phase]. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Use of air polishing for supra- and subgingival biofilm removal for treatment of residual periodontal pockets and supportive periodontal care: a systematic review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Microbiome in maintained periodontitis and its shift over a single maintenance interval of 3 months. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of ultrasonic cleaning and air polishing on the marginal integrity of radicular amalgam and composite resin restorations. An in vitro study. [2019]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Microbial diffusion by aerosol during ultrasonic scaling: descriptive study]. [2011]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy of air polishing devices in supportive periodontal therapy: Clinical, microbiological and patient-centred outcomes. A systematic review. [2023]