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

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-implantitis; Titanium Brush; Non-surgical Submucosal Debridement
• Intervention / Treatment: Device: Submucosal debridement; Device: Submucosal debridement + titanium brushes

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javi Vilarrasa; Phone Number: +34 628553000; Email: jvilarrasa@uic.es
• Study Contact Backup: Name: Fares Al Hajeb; Phone Number: +34 696062892; Email: faresalhajeb@uic.es

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Javi Vilarrasa; Phone Number: +34 628553000; Email: jvilarrasa@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants will receive submucosal debridement alone	Device: Submucosal debridement; Participants will undergo non-surgical submucosal debridement alone (SD); Device: Submucosal debridement + titanium brushes; Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)
Experimental: Test Group; Participants will receive submucosal debridement and titanium brushes	Device: Submucosal debridement; Participants will undergo non-surgical submucosal debridement alone (SD); Device: Submucosal debridement + titanium brushes; Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth changes	The primary outcome variable will be pocket depth changes at 1 year of follow-up.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth plaque index (FMPI)	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.	12 Months
Full mouth bleeding index (FMBI)	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.	12 Months
Modified plaque index (mPI)	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.	12 Months
Modified bleeding index (mBI)	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.	12 Months
Suppuration on probing (SoP)	Presence or absence of suppuration after gentle probing.	12 Months
Mucosal recession (MR)	Distance (mm) from the mucosal margin and the interface between implant and abutment.	12 Months
Keratinized mucosa (KM)	Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant.	12 Months
Radiographic parameters	Marginal bone level (MBL): distance (mm) between the implant shoulder and the base of the defect at the mesial and distal aspect.	12 Months
Radiographic parameters	Intra-bony defect (ID): distance (mm) between the bottom of the defect and the line connecting the distal and mesial inter-proximal bone crest.	12 Months
Radiographic parameters	Intra-bony defect width (WD): distance (mm) between the distal and mesial inter- proximal bone crest and the implant surface.	12 Months
Radiographic parameters	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.	12 Months
Microbiological analysis	Total bacterial load (CFU/ml) Microbiome alpha-diversity	12 Months
Microbiological analysis	Total bacterial load (CFU/ml) Microbiome beta-diversity	12 Months
Microbiological analysis	Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints	12 Months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): July 17, 2025
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: PER-ECL-2024-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No