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

Not Applicable

Recruiting

• Conditions: Titanium Brush; Non-surgical Submucosal Debridement; Peri-implantitis

• Registration Number: NCT06843928
• Lead Sponsor: Universitat Internacional de Catalunya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2025-02-23
• Last Update Submitted: 2025-02-23
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-07-17
• Study Completion: 2026-07-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pocket depth changes	12 Months	The primary outcome variable will be pocket depth changes at 1 year of follow-up.

Secondary Outcome Measures

Name	Time	Method
Modified plaque index (mPI)	12 Months	* Score 0: no detection of plaque.; * Score 1: plaque only recognized by running a probe across the smooth marginal surface of the implant.; * Score 2: plaque can be seen by the naked eye.; * Score 3: abundance of soft matter.
Modified bleeding index (mBI)	12 Months	* Score 0: no bleeding.; * Score 1: isolated bleeding spots visible.; * Score 2: blood forms a confluent red line on margin.; * Score 3: heavy or profuse bleeding.
Suppuration on probing (SoP)	12 Months	Presence or absence of suppuration after gentle probing.
Full mouth plaque index (FMPI)	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.
Radiographic parameters	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.
Microbiological analysis	12 Months	Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints
Full mouth bleeding index (FMBI)	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.
Mucosal recession (MR)	12 Months	Distance (mm) from the mucosal margin and the interface between implant and abutment.
Keratinized mucosa (KM)	12 Months	Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant.

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Barcelona, Catalonia, Spain