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

Official title

The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial

Overview

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.

Interventions

• 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)

Primary outcome measures

• Pocket depth changes [Time frame: 12 Months]

Secondary outcome measures (12)

• Full mouth plaque index (FMPI) [Time frame: 12 Months]
• Full mouth bleeding index (FMBI) [Time frame: 12 Months]
• Modified plaque index (mPI) [Time frame: 12 Months]
• Modified bleeding index (mBI) [Time frame: 12 Months]
• Suppuration on probing (SoP) [Time frame: 12 Months]
• Mucosal recession (MR) [Time frame: 12 Months]
• Keratinized mucosa (KM) [Time frame: 12 Months]
• Radiographic parameters [Time frame: 12 Months]
• Radiographic parameters [Time frame: 12 Months]
• Radiographic parameters [Time frame: 12 Months]
• Radiographic parameters [Time frame: 12 Months]
• Microbiological analysis [Time frame: 12 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universitat Internacional de Catalunya — Barcelona

Identifiers

NCT: NCT06843928 · PER-ECL-2024-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗