Decontamination Methods for Dental Implant Failure

Overseen By Carla Sanchez, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrea Ravida

Disqualifiers: Infectious diseases, Pregnancy, Radiotherapy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the best method for cleaning contaminated dental implants, focusing on two techniques: an air-polishing device (known as the Air-Flow device) and a titanium curette. Researchers aim to identify which method proves more effective in both surgical and non-surgical settings before implant removal. They will also compare these methods to no cleaning at all. Individuals with severe peri-implantitis, characterized by significant bone loss and inflammation around dental implants, who have not received related treatments in the last six months, may qualify for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to significant dental research that could enhance implant care for many.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that might interfere with surgery or healing, you may need to discuss this with the trial team.

What prior data suggests that these decontamination methods are safe for dental implant procedures?

Research has shown that both the titanium tool and the air-polishing device are generally safe for cleaning dental implants. Studies have found that titanium tools effectively clean implant surfaces, though there is concern that tiny titanium particles might cause irritation, potentially leading to more implant issues.

For the air-polishing device, studies suggest it performs as well as other cleaning methods. Patients have reported good results with air polishing, which is considered safe and well-tolerated. Both methods aim to clean implant surfaces to prevent further problems.

Overall, both treatments have been used in other settings without major safety concerns. However, like any treatment, risks exist, so discussing any concerns with a healthcare professional is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative decontamination methods for dental implant failure. Standard care usually involves mechanical cleaning with tools like titanium curettes, but this trial also investigates the use of erythritol powder delivered through an Airflow device. This method offers a potentially less invasive alternative, with the Airflow device allowing for precise cleaning without needing to cut and lift the gum tissue (flap elevation). By comparing surgical and non-surgical techniques, researchers aim to identify more effective and less invasive ways to manage implant failures, which could lead to improved patient outcomes and comfort.

What evidence suggests that these decontamination methods are effective for dental implant failure?

This trial will compare different decontamination methods for dental implant failure. One treatment arm involves surgical decontamination using titanium curettes. Studies have shown that titanium curettes can effectively clean dental implants during surgery by removing build-up around the implant. Another arm will test surgical decontamination using erythritol powder for air-polishing. Research indicates that erythritol powder effectively reduces the bacterial layer on implants without causing harm. Non-surgical decontamination methods using either titanium curettes or erythritol powder will also be evaluated in separate arms. Both cleaning methods offer benefits, and the best choice depends on the specific needs of the implant and surrounding area. ^{6 7 8 9 10}

Who Is on the Research Team?

Andrea Ravida, DDS MS PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I haven't had surgery or treatments around an implant in the last 6 months.

Exclusion Criteria

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

Pregnant women or planning to become pregnant (self-reported)

I have an infection in the teeth next to my treatment area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo non-surgical or surgical decontamination of implants followed by implant removal

1 day

1 visit (in-person)

Post-operative Care

Participants receive post-operative care including suture removal and follow-up on healing

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Air-Flow device
• Titanium Curette

Trial Overview 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.

How Is the Trial Designed?

Group I: Surgical decontamination with titanium curettes prior to implant removal Experimental Treatment 1 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 removal Experimental Treatment 1 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 explantation Experimental Treatment 1 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 removal Experimental Treatment 1 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 removal Active Control 1 Intervention

No decontamination will be performed on implants in this group.

Air-Flow device is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Air-Flow device for:

• Peri-implantitis treatment
• Dental implant maintenance

Approved in United States as Air-polishing device for:

• Peri-implantitis treatment
• Dental implant maintenance

Approved in Canada as Air-Flow device for:

• Peri-implantitis treatment
• Dental implant maintenance

Who Is Running the Clinical Trial?

Andrea Ravida

Lead Sponsor

Trials

2

Recruited

140+

Association for Dental Infection Control

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

Titanium brushes (TiB) were found to be the most effective method for decontaminating dental implants affected by peri-implantitis, outperforming other methods like Gracey curettes and air-polishing techniques.

The study revealed that the angle of bone defects affects debridement efficiency, with 60° defects being the easiest to clean, while 30° defects posed the greatest challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of different implant surface decontamination methods using spectrophotometric analysis: an in vitro study. Giffi, R., Pietropaoli, D., Mancini, L., et al.[2023]

Air-polishing is an effective method for decontaminating implant surfaces, showing no significant surface damage after treatment, which is important for maintaining implant integrity.

Surgical air-polishing demonstrated superior cleaning efficacy compared to non-surgical methods, indicating that the approach may be more beneficial in clinical settings for ensuring implant cleanliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro surgical and non-surgical air-polishing efficacy for implant surface decontamination in three different defect configurations. Tuchscheerer, V., Eickholz, P., Dannewitz, B., et al.[2021]

Air polishing is recognized as a promising alternative method for managing biofilms associated with dental implants, particularly for conditions like peri-implant mucositis and peri-implantitis.

The consensus from an expert meeting at the EUROPERIO 8 conference emphasizes the need for practical recommendations on the clinical use of air polishing, based on a systematic review of its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations on the clinical application of air polishing for the management of peri-implant mucositis and peri-implantitis. Schwarz, F., Becker, K., Bastendorf, KD., et al.[2022]

In a randomized clinical trial with 30 patients over 12 months, the use of a titanium brush for implant surface decontamination during peri-implantitis treatment led to a significant reduction in probing pocket depth (PPD) compared to standard methods, with a reduction of 4.87 mm versus 2.85 mm (p = 0.009).

The study demonstrated that the titanium brush not only improved PPD reduction but also resulted in lower residual PPD measurements, indicating enhanced efficacy of the treatment approach for managing peri-implantitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adjunctive effect of a titanium brush in implant surface decontamination at peri-implantitis surgical regenerative interventions: A randomized controlled clinical trial. de Tapia, B., Valles, C., Ribeiro-Amaral, T., et al.[2019]

In a study involving 42 patients, the air powder cleaning system was found to be more effective at removing debris from titanium abutments compared to both laser and curette methods.

Despite the differences in cleaning efficacy, all three systems (air powder, laser, and curette) did not significantly alter the surface roughness of the titanium abutments, suggesting they are safe for maintaining implant hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo study of titanium healing screws surface modifications after different debridment procedure. Marconcini, S., Genovesi, AM., Marchisio, O., et al.[2022]

The air-abrasive device (Perio-Flow) showed statistically significant improvements in gingival index (GI) and probing pocket depth (PPD) compared to the control method, indicating its efficacy in treating peri-implantitis at the implant level.

Despite the improvements observed, only 8% of patients in both treatment groups were stabilized after 12 months, suggesting that neither treatment fully resolved the disease, highlighting the need for longer follow-up studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an air-abrasive device with amino acid glycine-powder during surgical treatment of peri-implantitis. Toma, S., Lasserre, JF., Taïeb, J., et al.[2021]

Both Er:YAG and Er, Cr:YSGG lasers effectively decontaminated titanium surfaces from oral biofilms, with the Er, Cr:YSGG laser showing the lowest residual plaque area and viable bacteria compared to plastic curettes.

The treatment time was significantly shorter for laser methods compared to plastic curettes, indicating that lasers are not only effective but also more efficient for implant surface decontamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Er, Cr:YSGG laser and a Er:YAG laser treatment on oral biofilm-contaminated titanium. Park, SH., Kim, OJ., Chung, HJ., et al.[2021]

Air abrasion (AA) is an effective method for cleaning titanium surfaces, showing superior or equal cleaning efficacy compared to other decontamination methods, while causing minimal damage, especially on nonmodified surfaces.

Although AA preserves biocompatibility better on noncontaminated surfaces, it has limitations in restoring biocompatibility on contaminated surfaces, particularly when using harder abrasive powders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of air abrasive decontamination on titanium surfaces: A systematic review of in vitro studies. Moharrami, M., Perrotti, V., Iaculli, F., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9299917/

Erythritol air polishing in the surgical treatment of peri‐implantitis Erythritol air polishing as implant surface cleansing method was not more effective than saline during resective surgical treatment of peri‐implantitis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12191619/

Effectiveness of Erythritol-Based Air Polishing and ... Effectiveness of erythritol-based air polishing and ultrasonic instrumentation with PEEK inserts in peri-implant maintenance: a randomized clinical trial

3. sciencedirect.com sciencedirect.com/science/article/pii/S1882761624000097

The clinical efficacy of powder air-polishing in the non- ... Air-polishing moderately mitigated short-term PI/PS for peri-implant mucositis and showed a similar improvement in long-term BOP and bone loss for peri- ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/idh.12836

Efficacy and safety of erythritol air‐polishing in implant ... Erythritol air-polishing appeared to be significantly more effective in reducing biofilm compared to other treatments, without causing any significant damage.

5. mdpi.com mdpi.com/2079-6412/15/3/327

Efficacy of Air-Polishing with Sodium Bicarbonate vs. ... The findings suggest that air polishing with erythritol is as effective as sodium bicarbonate in reducing the bacterial concentration on dental implants in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06430268

Study Details | NCT06430268 | Efficacy of Non-surgical ... This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8944123/

Efficacy of air polishing in comparison with hand ... This systematic review aimed to assess clinical outcomes, patients' perception, and cost-effectiveness of repeated periodontal therapy with air ...

8. mdpi.com mdpi.com/2076-3417/14/17/7775

Comparison of Air Abrasion and Mechanical ... The findings of the study indicate that the use of air abrasion was just as effective as other mechanical decontamination methods in reducing probing depth and ...

9. nature.com nature.com/articles/s41598-025-08946-8

An in vitro study exploring a new method for managing peri ... This study investigated the in-vitro efficacy of the Ten-Second Technique (TST), a novel protocol designed for treating peri-implant disease ...

10. dental24.se dental24.se/wp-content/uploads/2024/06/theuseofairabrasivedevicesforimplantsurfacedecontamination.narrativereview.2024.regidoramerioderksortiz-vigon.pdf

The use of air abrasive devices for implant surface ... This chapter aims at elucidating the use of air polishing devices for implant surface decontamination in the management of peri- implantitis. a).