Clinical trial NCT06843928: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implantitis
Titanium Brush
Non-surgical Submucosal Debridement
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pocket depth changes
timeFrame: 12 Months
Secondary outcomes:
measure: Full mouth plaque index (FMPI)
timeFrame: 12 Months
measure: Full mouth bleeding index (FMBI)
timeFrame: 12 Months
measure: Modified plaque index (mPI)
timeFrame: 12 Months
measure: Modified bleeding index (mBI)
timeFrame: 12 Months
measure: Suppuration on probing (SoP)
timeFrame: 12 Months
measure: Mucosal recession (MR)
timeFrame: 12 Months
measure: Keratinized mucosa (KM)
timeFrame: 12 Months
measure: Radiographic parameters
timeFrame: 12 Months
measure: Radiographic parameters
timeFrame: 12 Months
measure: Radiographic parameters
timeFrame: 12 Months
measure: Radiographic parameters
timeFrame: 12 Months
measure: Microbiological analysis
timeFrame: 12 Months
measure: Microbiological analysis
timeFrame: 12 Months
measure: Microbiological analysis
timeFrame: 12 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalonia
Study officials:
References: