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Clinical Trials in Spain / NCT06843928
Recruiting Not applicable

The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis

NCT06843928 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-06-12
Last updated
2025-02-25

Condition(s) studied

Peri-implantitisTitanium BrushNon-surgical Submucosal Debridement

Investigational drug(s) / intervention(s)

Submucosal debridementSubmucosal debridement + titanium brushes

Submucosal debridement: Participants will undergo non-surgical submucosal debridement alone (SD)

Submucosal debridement + titanium brushes: Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universitat Internacional de Catalunya Barcelona Catalonia Recruiting

More Universitat Internacional de Catalunya trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06843928 on ClinicalTrials.gov ↗ ← All trials in Spain