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

NCT ID: NCT06843928

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2026-07-16

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.

Conditions

Peri-implantitis; Titanium Brush; Non-surgical Submucosal Debridement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Participants will receive submucosal debridement alone

Group Type: ACTIVE_COMPARATOR

Submucosal debridement

Intervention Type: DEVICE

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

Submucosal debridement + titanium brushes

Intervention Type: DEVICE

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

Test Group

Participants will receive submucosal debridement and titanium brushes

Group Type: EXPERIMENTAL

Submucosal debridement

Intervention Type: DEVICE

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

Submucosal debridement + titanium brushes

Intervention Type: DEVICE

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

Interventions

Submucosal debridement

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

Intervention Type: DEVICE

Submucosal debridement + titanium brushes

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Javi Vilarrasa

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Javi Vilarrasa

Role: CONTACT

jvilarrasa@uic.es

+34 628553000

Fares Al Hajeb

Role: CONTACT

faresalhajeb@uic.es

+34 696062892

Facility Contacts

Javi Vilarrasa

Role: primary

jvilarrasa@uic.es

+34 628553000

Other Identifiers

PER-ECL-2024-05

Identifier Type: -

Identifier Source: org_study_id