Health TrialsbyHealthPanel

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

ConditionsPeri-implantitisTitanium BrushNon-surgical Submucosal Debridement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Test GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pocket depth changes

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

Time frame
12 Months

Secondary outcomes

1

Full mouth plaque index (FMPI)

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.

Time frame
12 Months
2

Full mouth bleeding index (FMBI)

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.

Time frame
12 Months
3

Modified plaque index (mPI)

* 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.

Time frame
12 Months
4

Modified bleeding index (mBI)

* 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.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitat Internacional de Catalunya

Lead sponsor

Source ClinicalTrials.gov
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