Peri-implantitisNCT06843928
The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis
A study testing Submucosal debridement and Submucosal debridement + titanium brushes in people with Peri-implantitis and Titanium Brush, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis, Titanium Brush, Non-surgical Submucosal Debridement
- What is being tested?
- Submucosal debridement and Submucosal debridement + titanium brushes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2024to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Implant function time ≥ 1 year.
- Presence of ≥2mm of keratinized peri-implant mucosa.
- Screw-retained single and multiple restorations.
Who cannot join
- 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.
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- Mobility of the implant.
- Known allergy or intolerance to macrolides.
- Use of systemic antibiotics during the last 3 months.
- Need of endocarditis prophylaxis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Barcelona, Catalonia, 08195
Javi Vilarrasa, +34 628553000, jvilarrasa@uic.es
About this study
Official title: The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical 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.
- Being tested
- Submucosal debridement, Submucosal debridement + titanium brushes
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal debridementDevice
Participants will undergo non-surgical submucosal debridement alone (SD)
Submucosal debridement + titanium brushesDevice
Participants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will receive submucosal debridement alone Receives: Device: Submucosal debridement; Device: Submucosal debridement + titanium brushes |
| Test Group | Experimental | Participants will receive submucosal debridement and titanium brushes Receives: Device: Submucosal debridement; Device: Submucosal debridement + titanium brushes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth changes
The primary outcome variable will be pocket depth changes at 1 year of follow-up.
Measured: 12 Months
Secondary outcomes (14)
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
Suppuration on probing (SoP)
Presence or absence of suppuration after gentle probing.
Measured: 12 Months
Mucosal recession (MR)
Distance (mm) from the mucosal margin and the interface between implant and abutment.
Measured: 12 Months
Keratinized mucosa (KM)
Distance (mm) from the mucosal margin to the mucogingival junction at the midbuccal aspect of the implant.
Measured: 12 Months
Radiographic parameters
Marginal bone level (MBL): distance (mm) between the implant shoulder and the base of the defect at the mesial and distal aspect.
Measured: 12 Months
Radiographic parameters
Intra-bony defect (ID): distance (mm) between the bottom of the defect and the line connecting the distal and mesial inter-proximal bone crest.
Measured: 12 Months
Radiographic parameters
Intra-bony defect width (WD): distance (mm) between the distal and mesial inter- proximal bone crest and the implant surface.
Measured: 12 Months
Radiographic parameters
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.
Measured: 12 Months
Microbiological analysis
Total bacterial load (CFU/ml) Microbiome alpha-diversity
Measured: 12 Months
Microbiological analysis
Total bacterial load (CFU/ml) Microbiome beta-diversity
Measured: 12 Months
Microbiological analysis
Total bacterial load (CFU/ml) Relative and differential bacterial genera abundance at different timepoints
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start12 Jun 2024
- Primary completion17 Jul 2025 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javi Vilarrasa, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843928
- Sponsor's protocol ID
- PER-ECL-2024-05
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06843928
- Acronym / sponsor ID
- PER-ECL-2024-05
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 17 Jul 2025 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Submucosal debridement, Device: Submucosal debridement + titanium brushesParticipants will receive submucosal debridement alone |
| Test Group | Experimental | Device: Submucosal debridement, Device: Submucosal debridement + titanium brushesParticipants will receive submucosal debridement and titanium brushes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)].
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submucosal debridementParticipants will undergo non-surgical submucosal debridement alone (SD) | Device | Control Group, Test Group |
| Submucosal debridement + titanium brushesParticipants will undergo non-surgical submucosal debridement + titanium brushes (SD+TiBr) | Device | Control Group, Test Group |
Primary outcome
Pocket depth changes
Time frame: 12 Months
The primary outcome variable will be pocket depth changes at 1 year of follow-up.
14 secondary outcomes
Full mouth plaque index (FMPI)
Time frame: 12 Months
Full mouth bleeding index (FMBI)
Time frame: 12 Months
Modified plaque index (mPI)
Time frame: 12 Months
Modified bleeding index (mBI)
Time frame: 12 Months
Suppuration on probing (SoP)
Time frame: 12 Months
Mucosal recession (MR)
Time frame: 12 Months
Keratinized mucosa (KM)
Time frame: 12 Months
Radiographic parameters
Time frame: 12 Months
Radiographic parameters
Time frame: 12 Months
Radiographic parameters
Time frame: 12 Months
Radiographic parameters
Time frame: 12 Months
Microbiological analysis
Time frame: 12 Months
Microbiological analysis
Time frame: 12 Months
Microbiological analysis
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal debridement and Submucosal debridement + titanium brushes in people with Peri-implantitis and Titanium Brush, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javi Vilarrasa (+34 628553000, jvilarrasa@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth changes (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.