Implantoplasty for Peri-Implant Mucositis

Overseen By Carla Sanchez, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antibiotics, Anticoagulants, Anti-inflammatories

Disqualifiers: Infectious diseases, Bone disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with implantoplasty (IP) compared to those treated without IP.

Will I have to stop taking my current medications?

If you are on significant medications for systemic conditions, like chronic anti-inflammatory drugs, antibiotics, or anticoagulants, you may not be eligible for the study. However, short-term use of pain relievers or cold medicine is allowed.

What data supports the effectiveness of the treatment for peri-implant mucositis?

Research shows that nonsurgical treatments, like mechanical cleaning, can be effective for peri-implant mucositis, which is a mild inflammation around dental implants. This suggests that similar approaches, like implantoplasty, might also help in resolving this condition. ^{1 2 3 4 5}

How is implantoplasty unique in treating peri-implant mucositis?

Implantoplasty is unique because it involves mechanically smoothing the surface of dental implants to reduce bacterial load and promote healing, which is different from other treatments that may not focus on altering the implant surface itself. ^{6 7 8 9 10}

Research Team

Andrea Ravida

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults aged 18-80 in good health, with specific dental implants previously treated for peri-implantitis. Participants should have minimal bacteria on the implant, stable bone levels around it, and healthy gums. Excluded are those with active infections, certain medical conditions requiring premedication before dental visits, pregnant women or those planning pregnancy, heavy smokers, and individuals on significant drug therapy.

Inclusion Criteria

I am in good health overall.

My dental implants have a probing depth of 4 mm or less.

I have been treated for gum disease around my dental implant, exposing part of it.

Exclusion Criteria

Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months of study onset (self-reported)

I need medication before any dental procedures due to my medical condition.

I have a bone condition like osteoporosis or vitamin D deficiency.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Experimental Peri-implant Mucositis

Participants undergo a 21-day period of experimentally induced peri-implant mucositis while wearing a stent over the implant area during routine oral health care.

3 weeks

4 visits (in-person)

Resolution of Peri-implant Mucositis

Participants undergo a 21-day period for the resolution of induced peri-implant mucositis with continued monitoring and sample collection.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for any remaining inflammation and treated as necessary every 3-4 weeks until resolved.

Long-term

Treatment Details

Interventions

• Induction of experimental peri-implant mucositis
• Resolution of experimental peri-implant mucositis

Trial Overview The study aims to compare the healing process of gum inflammation around dental implants (PIM) that were previously smoothed down (IP) versus not. It will look at clinical signs of healing as well as immune response and bacterial changes during the development and resolution of PIM.

Participant Groups

Group I: Implants with history of peri-implantitis Experimental Treatment 2 Interventions

Implant(s) treated previously for peri-implantitis with or without exposed polished surface, no PD \> 4 mm and \< 50% bone loss.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

References

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

Clinical outcomes and associated factors in the treatment of peri-implant mucositis, combining mechanical debridement and prosthesis modification: A 30-month follow-up prospective case series. [2023]

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

The therapy of peri-implantitis: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The efficacy of interventions to treat peri-implantitis: a Cochrane systematic review of randomised controlled clinical trials. [2021]

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

Nonsurgical treatment for peri-implant mucositis: A systematic review and meta-analysis. [2021]

5. Denmark pubmed.ncbi.nlm.nih.gov

Long-term outcome of surgical treatment of peri-implantitis. A 2-11-year retrospective study. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Efficacy of implantoplasty in management of peri-implantitis: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Experimental implantoplasty outcomes correlate with fibroblast growth in vitro. [2023]

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

Implantoplasty Enhancing Peri-implant Bone Stability Over a 3-Year Follow-up: A Case Series. [2022]

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

The Impact of Implantoplasty in Regenerated and Nonregenerated Treatment Modalities in Peri-implantitis: A Systematic Review and Meta-analysis. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Re-osseointegration of peri-implantitis bone defects: an experimental study in dogs]. [2018]