Plaque RemovalNCT07724054
Access to Hygiene in Patients With Dental Implants Using Two Toothbrushes
A study testing Plaque removal in people with Plaque Removal and Peri Implant Mucositis, run by Octavi Camps-Font at 1 site in Spain.
Trial summary
Peri-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Removal, Peri Implant Mucositis
- What is being tested?
- Plaque removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 18 May 2024to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with peri-implant mucositis according to the 2017 World Workshop Classification.
- Presence of a screw-retained implant-supported prosthesis comprising one to three crowns.
- Attendance at the Implant Maintenance Unit during the recruitment period.
Who cannot join
- Use of systemic antibiotics or antiseptic mouthrinses within the previous month.
- Diagnosis of peri-implant health or peri-implantitis.
- Special healthcare needs, mobility impairment, or cognitive/psychiatric disorders preventing adequate oral hygiene.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontològic Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial
Peri-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Polybutylene terephthalate (PBT) tapered-end bristles are more flexible than conventional medium-textured bristles and may improve access to peri-implant areas while increasing patient comfort. This study aims to compare the effectiveness of a PBT tapered-end toothbrush and a medium-textured toothbrush in plaque removal, peri-implant bacterial load reduction, and patient-reported outcomes in individuals with peri-implant mucositis. Each participant will use both toothbrushes in a randomized sequence separated by a six-week washout period. Visible plaque will be disclosed and quantified using standardized photographic analysis based on the Rustogi Modified Navy Plaque Index. Absolute and relative peri-implant bacterial loads of Porphyromonas gingivalis and Fusobacterium nucleatum, together with total bacterial load, will be quantified by quantitative polymerase chain reaction. Patient satisfaction, including perceived discomfort, comfort, ease of handling and intention to use, will be assessed using visual analogue scales.
- Conditions
- Plaque Removal, Peri Implant Mucositis
- Being tested
- Plaque removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque removalOther
Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Medium-textured toothbrush | Active comparator | Plaque removal with a medium-textured toothbrush Receives: Other: Plaque removal |
| Polybutylene terephthalate (PBT) tapered-end toothbrush | Experimental | Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush Receives: Other: Plaque removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of plaque-stained surfaces
Measured: Inmediately after the intervention
Secondary outcomes (3)
Satisfaction questionnaire scores
Several visual analogue scales (VAS) going from 0 to 10 points will be handled, being 10 the highest score, regarding "Discomfort", "Ease of use" and "Comfort"
Measured: Inmediately after the intervention
Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum
Measured: When the microbiological samples were analyzed
Total bacterial load quantified using universal 16S rDNA primers
Measured: When microbial samples were analyzed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start18 May 2024
- Primary completion20 May 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque RemovalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octavi Camps-Font
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Octavi Camps-Font, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724054
- Sponsor's protocol ID
- 42/2024
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07724054
- Acronym / sponsor ID
- 42/2024
- Conditions
- Plaque Removal, Peri Implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Octavi Camps-FontUniversity, hospital or other
- Study start
- 18 May 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 23 Jul 2026 (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-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Polybutylene terephthalate (PBT) tapered-end bristles are more flexible than conventional medium-textured bristles and may improve access to peri-implant areas while increasing patient comfort. This study aims to compare the effectiveness of a PBT tapered-end toothbrush and a medium-textured toothbrush in plaque removal, peri-implant bacterial load reduction, and patient-reported outcomes in individuals with peri-implant mucositis. Each participant will use both toothbrushes in a randomized sequence separated by a six-week washout period. Visible plaque will be disclosed and quantified using standardized photographic analysis based on the Rustogi Modified Navy Plaque Index. Absolute and relative peri-implant bacterial loads of Porphyromonas gingivalis and Fusobacterium nucleatum, together with total bacterial load, will be quantified by quantitative polymerase chain reaction. Patient satisfaction, including perceived discomfort, comfort, ease of handling and intention to use, will be assessed using visual analogue scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium-textured toothbrush | Active comparator | Other: Plaque removalPlaque removal with a medium-textured toothbrush |
| Polybutylene terephthalate (PBT) tapered-end toothbrush | Experimental | Other: Plaque removalPlaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults diagnosed with peri-implant mucositis according to the 2017 World Workshop Classification.
- Presence of a screw-retained implant-supported prosthesis comprising one to three crowns.
- Attendance at the Implant Maintenance Unit during the recruitment period.
Key exclusion criteria (3 listed)
- Use of systemic antibiotics or antiseptic mouthrinses within the previous month.
- Diagnosis of peri-implant health or peri-implantitis.
- Special healthcare needs, mobility impairment, or cognitive/psychiatric disorders preventing adequate oral hygiene.
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 |
|---|---|---|
| Plaque removalPlaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush | Other | Medium-textured toothbrush, Polybutylene terephthalate (PBT) tapered-end toothbrush |
Primary outcome
Changes in the number of plaque-stained surfaces
Time frame: Inmediately after the intervention
3 secondary outcomes
Satisfaction questionnaire scores
Time frame: Inmediately after the intervention
Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum
Time frame: When the microbiological samples were analyzed
Total bacterial load quantified using universal 16S rDNA primers
Time frame: When microbial samples were analyzed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Related trials for Plaque Removal
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Recruiting
Plaque Removal Efficiency in Children With Specific Learning Disabilities
Specific Learning Disabilities, Dental Plaque
Not yet recruiting
Plaque Removal in Children Using Charcoal and Nylon Toothbrushes
Effectiveness of Charcoal-infused Versus Nylon Bristle Toothbrushes on Plaque Removal and Oral Bacterial Reduction in Children
Active, not recruiting
Diode Laser as an Adjunct to Professional Mechanical Plaque Removal
Periodontitis, Pocket, Periodontal
Recruiting
Is Professional Tooth Cleaning Necessary for Managing Gingivitis (Gingival Inflammation) if Subjects Use Intelligent Toothbrushes?
Gingivitis, Periodontitis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque removal in people with Plaque Removal and Peri Implant Mucositis, run by Octavi Camps-Font 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of plaque-stained surfaces (time frame: Inmediately after the intervention). 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 23 Jul 2026.