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Device

Decontamination Methods for Dental Implant Failure

N/A
Recruiting
Led By Andrea Ravida, DDS MS PhD
Research Sponsored by Andrea Ravida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult individuals between 18 and 80 years of age who require the explantation of at least one titanium or titanium alloy implant due to severe peri-implantitis (> 50% bone loss and signs of inflammation)
Be older than 18 years old
Must not have
Acute infection associated with adjacent teeth
History of radiotherapy in the head and neck or chemotherapy in the last 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up right after decontamination and implant removal (t0)
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test two different ways to clean contaminated implant surfaces: using an air-polishing device or a titanium curette. The methods will be used in both non-surgical and surgical settings, and

Who is the study for?
This trial is for individuals with dental implant failures or peri-implantitis, which is a condition affecting the tissues around dental implants. Specific eligibility criteria are not provided, but typically participants would need to have one of these conditions and be suitable candidates for the interventions being tested.
What is being tested?
The study aims to compare two cleaning methods on contaminated dental implants: an air-polishing device and a titanium curette. These will be used in both non-surgical and surgical settings before removing the implant for further laboratory analysis to determine which method is more effective at decontamination.
What are the potential side effects?
Potential side effects are not detailed in the information provided. However, common risks associated with dental procedures may include discomfort, swelling, bleeding at the site of intervention, infection risk, and possible damage to surrounding teeth or gums.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old and need to have a titanium implant removed due to severe gum and bone inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an infection in the teeth next to my treatment area.
Select...
I haven't had head/neck radiation or chemotherapy in the last 3 years.
Select...
I do not have any active infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~right after decontamination and implant removal (t0)
This trial's timeline: 3 weeks for screening, Varies for treatment, and right after decontamination and implant removal (t0) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of clean implant surface area following implant decontamination approaches
Secondary study objectives
Atomic composition of the implants after removal
Bacterial composition of the implants
Biocompatibility analysis of the implant
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Surgical decontamination with titanium curettes prior to implant removalExperimental Treatment1 Intervention
Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants
Group II: Surgical decontamination with erythritol powder prior to implant removalExperimental Treatment1 Intervention
Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned.
Group III: Non-surgical decontamination with titanium curettes followed by explantationExperimental Treatment1 Intervention
Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation.
Group IV: : Non-surgical decontamination with erythritol powder prior to implant removalExperimental Treatment1 Intervention
Without any flap elevation, the supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant.
Group V: No decontamination prior to implant removalActive Control1 Intervention
No decontamination will be performed on implants in this group.

Find a Location

Who is running the clinical trial?

Andrea RavidaLead Sponsor
1 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Peri-Implantitis
52 Patients Enrolled for Peri-Implantitis
Association for Dental Infection ControlUNKNOWN
Andrea Ravida, DDS MS PhDPrincipal InvestigatorUniversity of Pittsburgh
~60 spots leftby Jun 2026
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