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

Last updated: February 23, 2025
Sponsor: Universitat Internacional de Catalunya
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Submucosal debridement

Submucosal debridement + titanium brushes

Clinical Study ID

NCT06843928
PER-ECL-2024-05
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Adult patients with ≥18 years of age.

  • Ability to understand all the study procedures and to comply with them along theentire 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 ofbleeding and/or suppuration on gentle probing with probing depth of ≥6 mm, andprogressive bone loss. In the absence of initial radiographs, a bone level ≥2 mmapical to the most coronal part of the intrabony portion of the implant will be usedas 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

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 steroidtherapy, metabolic bone disease, radiation, immunosuppressive disease, hepaticdysfunction, immunosuppressive disease, autoimmune disease).

  • Pregnant or lactating women.

  • Previous surgical and non-surgical treatment of affected implants at least 12 monthsprior 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 Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Submucosal debridement
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
July 16, 2026

Connect with a study center

  • Universitat Internacional de Catalunya

    Barcelona, Catalonia 08195
    Spain

    Active - Recruiting

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