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

Universitat Internacional de Catalunya

Status: Enrolling

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

Treatments: Device: Submucosal debridement + titanium brushes; Device: Submucosal debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT06843928

PER-ECL-2024-05

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Participants will receive submucosal debridement alone

Treatment:

Device: Submucosal debridement

Device: Submucosal debridement + titanium brushes

Test Group

Experimental group

Description:

Participants will receive submucosal debridement and titanium brushes

Treatment:

Device: Submucosal debridement

Device: Submucosal debridement + titanium brushes