Universitat Internacional de Catalunya
Barcelona, Catalonia, 08195, Spain
Location status: Recruiting
NCT Number: NCT06843928
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, Catalonia, 08195, Spain
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo non-surgical submucosal debridement alone (SD)
Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)
Time frame: 12 Months
The primary outcome variable will be pocket depth changes at 1 year of follow-up.
Time frame: 12 Months
Assessed dichotomously as presence or absence of plaque will be scored if present along the gingival margin and if it can be removed with the side of the probe. The percentage of surfaces with plaque out of the total number of examined tooth surfaces will be calculated.
Time frame: 12 Months
Assessed dichotomously as presence or absence of bleeding after 30 seconds of gently probing. The proportion of bleeding surfaces out of the total number of examined surfaces will be calculated.
Time frame: 12 Months
Time frame: 12 Months
Time frame: 12 Months
Presence or absence of suppuration after gentle probing.
Time frame: 12 Months
Distance (mm) from the mucosal margin and the interface between implant and abutment.
Time frame: 12 Months
Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant.
Time frame: 12 Months
Marginal bone level (MBL): distance (mm) between the implant shoulder and the base of the defect at the mesial and distal aspect.
Time frame: 12 Months
Intra-bony defect (ID): distance (mm) between the bottom of the defect and the line connecting the distal and mesial inter-proximal bone crest.
Time frame: 12 Months
Intra-bony defect width (WD): distance (mm) between the distal and mesial inter- proximal bone crest and the implant surface.
Time frame: 12 Months
Angulation of the intra-bony defect (AD): angle resulted from a vertical line along the outer implant surface and a line extending along the peri-implant bone defect.
Time frame: 12 Months
Total bacterial load (CFU/ml) Microbiome alpha-diversity
Time frame: 12 Months
Total bacterial load (CFU/ml) Microbiome beta-diversity
Time frame: 12 Months
Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints
Contact information is provided by the study sponsor or research team.
Fares Al Hajeb
CONTACT
Javi Vilarrasa
CONTACT
Universitat Internacional de Catalunya
Other
The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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