Using a titanium brush to treat peri-implantitis

The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial

This study is testing if using a titanium brush along with regular cleaning can better treat gum disease around dental implants compared to just using steel tools.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitat Internacional de Catalunya (other)
• Drugs / interventions: radiation
• Locations: 1 site (Barcelona, Catalonia)
• Trial ID: NCT06843928 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of using a titanium brush in conjunction with non-surgical submucosal debridement for treating peri-implantitis, a condition characterized by inflammation and bone loss around dental implants. The trial aims to compare the clinical, radiographic, and microbiological outcomes of this combined approach against traditional methods using steel curettes alone. Participants will undergo mechanical debridement to remove biofilm and calculus, with the titanium brush potentially enhancing plaque removal. The study will include adult patients with specific criteria related to their dental implants and oral hygiene.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with at least one titanium implant exhibiting signs of peri-implantitis.

Not a fit: Patients with untreated periodontitis or those who smoke more than 10 cigarettes per day may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients suffering from peri-implantitis.

How similar studies have performed: Previous studies have indicated that adjunctive measures like titanium brushes can enhance plaque removal, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Adult patients with ≥18 years of age.
* Ability to understand all the study procedures and to comply with them along the entire study period. Ability and willingness to give written informed consent.
* An adequate level of oral hygiene (plaque index ≤ 25%) (O'Leary et al., 1972).
* Treated periodontal disease.
* Presence of at least one titanium implant with peri-implantitis \[i.e., presence of bleeding and/or suppuration on gentle probing with probing depth of ≥6 mm, and progressive bone loss. In the absence of initial radiographs, a bone level ≥2 mm apical to the most coronal part of the intrabony portion of the implant will be used as threshold of disease (Romandini et al., 2021)\].
* Horizontal and vertical peri-implant bone defects.
* Implant function time ≥ 1 year.
* Presence of ≥2mm of keratinized peri-implant mucosa.
* Screw-retained single and multiple restorations.

Exclusion Criteria:

* Untreated periodontitis.
* Smokers \> 10 cigarettes per day.
* Local or systemic diseases that would interfere with routine periodontal therapy (i.e., uncontrolled diabetes mellitus, cancer, HIV, chronic high-dose steroid therapy, metabolic bone disease, radiation, immunosuppressive disease, hepatic dysfunction, immunosuppressive disease, autoimmune disease).
* Pregnant or lactating women.
* Previous surgical and non-surgical treatment of affected implants at least 12 months prior to the beginning of the study.
* Radiographic peri-implant bone loss \> two-thirds.
* Mobility of the implant.
* Known allergy or intolerance to macrolides.
* Use of systemic antibiotics during the last 3 months.
* Need of endocarditis prophylaxis.

Where this trial is running

Barcelona, Catalonia

• Universitat Internacional de Catalunya — Barcelona, Catalonia, Spain (RECRUITING)

Study contacts

• Study coordinator: Javi Vilarrasa

Conditions: Peri-implantitis, Titanium Brush, Non-surgical Submucosal Debridement