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NCT Number: NCT06843928

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

Location status: Recruiting

Location contact

Javi Vilarrasa

CONTACT

[email protected]

+34 628553000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Submucosal debridement

Device

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

Submucosal debridement + titanium brushes

Device

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

Primary outcomes

  1. Pocket depth changes

    Time frame: 12 Months

    The primary outcome variable will be pocket depth changes at 1 year of follow-up.

Secondary outcomes

  1. Full mouth plaque index (FMPI)

    Time frame: 12 Months

    Assessed dichotomously as presence or absence of plaque will be scored if present along the gingival margin and if it can be removed with the side of the probe. The percentage of surfaces with plaque out of the total number of examined tooth surfaces will be calculated.

  2. Full mouth bleeding index (FMBI)

    Time frame: 12 Months

    Assessed dichotomously as presence or absence of bleeding after 30 seconds of gently probing. The proportion of bleeding surfaces out of the total number of examined surfaces will be calculated.

  3. Modified plaque index (mPI)

    Time frame: 12 Months

    • Score 0: no detection of plaque.
    • Score 1: plaque only recognized by running a probe across the smooth marginal surface of the implant.
    • Score 2: plaque can be seen by the naked eye.
    • Score 3: abundance of soft matter.
  4. Modified bleeding index (mBI)

    Time frame: 12 Months

    • Score 0: no bleeding.
    • Score 1: isolated bleeding spots visible.
    • Score 2: blood forms a confluent red line on margin.
    • Score 3: heavy or profuse bleeding.
  5. Suppuration on probing (SoP)

    Time frame: 12 Months

    Presence or absence of suppuration after gentle probing.

  6. Mucosal recession (MR)

    Time frame: 12 Months

    Distance (mm) from the mucosal margin and the interface between implant and abutment.

  7. Keratinized mucosa (KM)

    Time frame: 12 Months

    Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant.

  8. Radiographic parameters

    Time frame: 12 Months

    Marginal bone level (MBL): distance (mm) between the implant shoulder and the base of the defect at the mesial and distal aspect.

  9. Radiographic parameters

    Time frame: 12 Months

    Intra-bony defect (ID): distance (mm) between the bottom of the defect and the line connecting the distal and mesial inter-proximal bone crest.

  10. Radiographic parameters

    Time frame: 12 Months

    Intra-bony defect width (WD): distance (mm) between the distal and mesial inter- proximal bone crest and the implant surface.

  11. Radiographic parameters

    Time frame: 12 Months

    Angulation of the intra-bony defect (AD): angle resulted from a vertical line along the outer implant surface and a line extending along the peri-implant bone defect.

  12. Microbiological analysis

    Time frame: 12 Months

    Total bacterial load (CFU/ml) Microbiome alpha-diversity

  13. Microbiological analysis

    Time frame: 12 Months

    Total bacterial load (CFU/ml) Microbiome beta-diversity

  14. Microbiological analysis

    Time frame: 12 Months

    Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints

Study contacts

Contact information is provided by the study sponsor or research team.

Fares Al Hajeb

CONTACT

[email protected]

+34 696062892

Javi Vilarrasa

CONTACT

[email protected]

+34 628553000

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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