Decontamination Methods for Dental Implant Failure

Overseen By Carla Sanchez, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Andrea Ravida

Disqualifiers: Infectious diseases, Pregnancy, Radiotherapy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used in the non-surgical and surgical setting, followed by implant removal. Then, in-vitro analysis to assess the efficacy of surface decontamination will be performed.

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 data supports the effectiveness of the treatment methods used in the clinical trial for dental implant failure?

Research shows that air-abrasive devices, like the Air-Flow device, are effective in cleaning dental implants by removing debris without damaging the implant surface. Additionally, air polishing has been recommended for managing conditions similar to implant failure, such as peri-implantitis, due to its ability to effectively manage biofilm (a layer of bacteria) on dental implants. ^{1 2 3 4 5}

How is the Air-Flow device and Titanium Curette treatment different from other treatments for dental implant failure?

This treatment is unique because it uses air-polishing devices and titanium brushes to clean the surface of dental implants, which can be more effective in removing contaminants compared to traditional methods. It combines mechanical cleaning with air abrasion, which has shown promising results in treating peri-implant diseases. ^{4 5 6 7 8}

Research Team

Andrea Ravida, DDS MS PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• Air-Flow device (Device)
• Titanium Curette (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an air-abrasive device with amino acid glycine-powder during surgical treatment of peri-implantitis. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

In vivo study of titanium healing screws surface modifications after different debridment procedure. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Recommendations on the clinical application of air polishing for the management of peri-implant mucositis and peri-implantitis. [2022]

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

In vitro surgical and non-surgical air-polishing efficacy for implant surface decontamination in three different defect configurations. [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The efficacy of different implant surface decontamination methods using spectrophotometric analysis: an in vitro study. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

Effect of a Er, Cr:YSGG laser and a Er:YAG laser treatment on oral biofilm-contaminated titanium. [2021]

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

Effects of air abrasive decontamination on titanium surfaces: A systematic review of in vitro studies. [2019]

8. United States 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. [2019]