The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis
The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial
Universitat Internacional de Catalunya
36 participants
Jun 12, 2024
INTERVENTIONAL
Conditions
Summary
Peri-implantitis is a plaque-associated condition occurring around dental implants, characterized by inflammation in the peri-implant mucosa and loss of supporting bone. To stop this progression, mechanical debridement of biofilm and calculus is commonly used to treat peri-implant lesions as well as the use of adjunctive measures such as titanium brushes. As observed, they improved plaque removal when compared with steel curettes alone. Therefore, it is of interest to evaluate the impact of this procedure in terms of clinical, radiographic and microbiological outcomes to assess their efficacy.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will undergo non-surgical submucosal debridement alone (SD)
Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06843928