NCT06843928

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2026

Completed
Last Updated

February 25, 2025

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 18, 2024

Last Update Submit

February 23, 2025

Conditions

Peri-implantitisTitanium BrushNon-surgical Submucosal Debridement

Outcome Measures

Primary Outcomes (1)

  • Pocket depth changes

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

    12 Months

Secondary Outcomes (14)

  • Full mouth plaque index (FMPI)

    12 Months

  • Full mouth bleeding index (FMBI)

    12 Months

  • Modified plaque index (mPI)

    12 Months

  • Modified bleeding index (mBI)

    12 Months

  • Suppuration on probing (SoP)

    12 Months

  • +9 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants will receive submucosal debridement alone

Device: Submucosal debridementDevice: Submucosal debridement + titanium brushes

Test Group

EXPERIMENTAL

Participants will receive submucosal debridement and titanium brushes

Device: Submucosal debridementDevice: Submucosal debridement + titanium brushes

Interventions

Submucosal debridementDEVICE

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

Control GroupTest Group
Submucosal debridement + titanium brushesDEVICE

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

Control GroupTest Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Javi Vilarrasa

CONTACT

+34 628553000jvilarrasa@uic.es

Fares Al Hajeb

CONTACT

+34 696062892faresalhajeb@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 18, 2024

First Posted

February 25, 2025

Study Start

June 12, 2024

Primary Completion

July 17, 2025

Study Completion

July 16, 2026

Last Updated

February 25, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)