Implantoplasty for Peri-Implant Mucositis

AR
CS
Overseen ByCarla Sanchez, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of implantoplasty, a process that smooths the surface of dental implants, in healing gum inflammation around dental implants, known as peri-implant mucositis. It compares treated implants with untreated ones, focusing on healing signs both physically and microscopically. Individuals with dental implants previously treated for peri-implantitis, who now have stable gum and bone conditions, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to advance dental care techniques.

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 prior data suggests that implantoplasty is safe for treating peri-implant mucositis?

Research shows that implantoplasty, a process that smooths implants, is a safe option for treating gum inflammation around implants, known as peri-implant mucositis. Although detailed information is limited, implantoplasty remains a common and generally well-tolerated dental procedure.

For peri-implant mucositis, studies indicate that nonsurgical treatments, like professional cleaning, effectively manage symptoms. These methods have been used in dental care for a long time, suggesting their safety.

While this trial doesn't specify a particular phase, the established use of implantoplasty suggests its safety. For those considering joining a clinical trial involving implantoplasty, existing research indicates it is likely safe and well-tolerated for most people.12345

Why are researchers excited about this trial?

Researchers are excited about implantoplasty for peri-implant mucositis because it offers a novel approach by focusing on the mechanical modification of implant surfaces. Unlike traditional treatments, which typically involve antimicrobial therapies or surgical interventions to manage inflammation, implantoplasty aims to smooth and polish the surface of dental implants. This technique can potentially reduce bacterial accumulation and improve healing. By directly altering the implant surface, this method could enhance long-term outcomes and offer an effective adjunct or alternative to conventional treatments for managing peri-implant mucositis.

What evidence suggests that implantoplasty is effective for peri-implant mucositis?

Research shows that implantoplasty (IP) might help manage peri-implant mucositis, an inflammation around dental implants. Studies have found that treatments for this condition can prevent worsening in up to 60% of cases. The American Academy of Periodontology recommends effective management, often involving cleaning around the implant and controlling risk factors. This trial will evaluate IP, which involves smoothing the implant surface, to determine if it reduces inflammation and aids tissue healing. While more research is needed, these findings suggest that IP could be promising for treating peri-implant mucositis.13678

Who Is on the Research Team?

AR

Andrea Ravida

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.
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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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Implants with history of peri-implantitisExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Citations

Peri-implant mucositis treatments in humansThis study aims to provide a comprehensive review of the available data regarding the effectiveness of peri-implant mucositis treatments in humans.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37819850/
Disease Resolution Following the Treatment of Peri ...Peri-implant mucositis treatment was most commonly reported to be successful in arresting disease progression for ≤ 60% of the cases, whereas ...
Treatment of peri-implant mucositis using an Er:YAG laser ...The primary outcome measure in the present study was change in BoP. The reduction of BoP at the implant in the Er:YAG laser group was 33.3%, ...
AO/AAP consensus on prevention and management of peri ...Peri-implant mucositis may be effectively managed with nonsurgical debridement and control of risk factors. This possibly represents the first ...
Resolution of peri‐implant mucositis following standard ...Clinical examination noted 30% disease resolution at the 6-month follow-up, while 43% showed no active bone resorption. OPG showed positive ...
Prevalence of Peri-Implant Mucositis ...The prevalence of P has been reported to range from 4.7% to 45% at the patient level and from 3.6% to 22.1% at the implant level. The ...
An in vitro study exploring a new method for managing peri ...Some studies have suggested that surgical interventions may be beneficial as a first-line approach for certain peri-implant infections. Despite ...
Antimicrobial photodynamic therapy for managing the peri- ...Antimicrobial photodynamic therapy (aPDT) combined with conventional treatment was more effective in improving peri‐implantitis symptoms.
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