Recession, GingivalRecessionNCT05949112
Toothbrush in the Genesis and Prevention of Dental Recessions
A study testing soft bristle toothbrush and mechanical toothbrush in people with Recession, Gingival, run by Universita degli Studi di Genova at 1 site in Italy.
Trial summary
The aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- soft bristle toothbrush and mechanical toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2023to Sep 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-60 years old;
- Fully dentate participants;
- Periodontal health
Who cannot join
- Patient with periodontitis
- Previous ortho treatment
- Insufficient restorations or prostheses.
- Systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.)
- Patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental
The aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution.
The study involves the recruitment of 90 patients with or without gingival recessions at the Dentistry service of the University of Genoa.
Read more
The first phase involves the evaluation of the brushing force on the genesis of gingival recessions. A questionnaire will be filled out and the same toothbrushes and toothpastes will be provided for one month to 30 patients with recessions and 30 patients without recessions. After a month, the "wear" of the manual toothbrush and the gingival health indices will be measured.
In this phase 60 patients with recessions will be divided into two groups according to the oral hygiene method that will be recommended. In the first group a super soft toothbrush will be delivered, in the second group a mechanical toothbrush. Gingival health indices will be taken and an intraoral scan will be done to measure recessions. At 6 months and 12 months the indices will be measured again and compared between the two groups.
This research has two objectives:
- Evaluate the differences in wear of the manual toothbrush head after one month of use between patients with gum recession and patients without gum recession. In the case of greater wear among patients with recessions it could be assumed that a greater brushing force is able to determine the formation of recessions.
- Try to understand if there are differences between the super soft manual toothbrush and the mechanical toothbrush regarding the effectiveness of use and the "delicacy" on recession. Both tools are currently recommended for patients with recessions, but there are no studies in the literature comparing the two tools.
- Conditions
- Recession, Gingival
- Being tested
- soft bristle toothbrush, mechanical toothbrush
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft bristle toothbrushDevice
manual toothbrushes
mechanical toothbrushDevice
sonic toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Manual | Experimental | Manual toothbrush Receives: Device: soft bristle toothbrush |
| Mechanical | Experimental | Mechanical toothbrush Receives: Device: mechanical toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Gengival recession from baseline to 6 months
gingival recession
Measured: 0-6 months
Change of Gengival recession from baseline to 12 months
gingival recession
Measured: 0-12 months
Secondary outcomes (4)
FMPS
full moth plaque score measured on 6 surfaces each tooth - percentage value
Measured: 6 months
FMPS
full moth plaque score measured on 6 surfaces each tooth - percentage value
Measured: 12 months
FMBS
full moth bleeding score measured on 6 surfaces each tooth - percentage value
Measured: 6 months
FMBS
full moth bleeding score measured on 6 surfaces each tooth - percentage value
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 posted17 Jul 2023
- Study start27 Jul 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pesce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949112
- Sponsor's protocol ID
- Recession1
- Acronym
- Recession
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual or Mechanical Toothbrush in the Genesis and Prevention of Dental
- ClinicalTrials.gov ID
- NCT05949112
- Acronym / sponsor ID
- Recession / Recession1
- Conditions
- Recession, Gingival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 27 Jul 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 Jul 2023 (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.
The aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution.
The study involves the recruitment of 90 patients with or without gingival recessions at the Dentistry service of the University of Genoa.
The first phase involves the evaluation of the brushing force on the genesis of gingival recessions. A questionnaire will be filled out and the same toothbrushes and toothpastes will be provided for one month to 30 patients with recessions and 30 patients without recessions. After a month, the "wear" of the manual toothbrush and the gingival health indices will be measured.
In this phase 60 patients with recessions will be divided into two groups according to the oral hygiene method that will be recommended. In the first group a super soft toothbrush will be delivered, in the second group a mechanical toothbrush. Gingival health indices will be taken and an intraoral scan will be done to measure recessions. At 6 months and 12 months the indices will be measured again and compared between the two groups.
This research has two objectives:
- Evaluate the differences in wear of the manual toothbrush head after one month of use between patients with gum recession and patients without gum recession. In the case of greater wear among patients with recessions it could be assumed that a greater brushing force is able to determine the formation of recessions.
- Try to understand if there are differences between the super soft manual toothbrush and the mechanical toothbrush regarding the effectiveness of use and the "delicacy" on recession. Both tools are currently recommended for patients with recessions, but there are no studies in the literature comparing the two tools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual | Experimental | Device: soft bristle toothbrushManual toothbrush |
| Mechanical | Experimental | Device: mechanical toothbrushMechanical toothbrush |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-60 years old;
- Fully dentate participants;
- Periodontal health
Key exclusion criteria (5 listed)
- Patient with periodontitis
- Previous ortho treatment
- Insufficient restorations or prostheses.
- Systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.)
- Patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
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 |
|---|---|---|
| soft bristle toothbrushmanual toothbrushes | Device | Manual |
| mechanical toothbrushsonic toothbrush | Device | Mechanical |
Primary outcome
Change of Gengival recession from baseline to 6 months
Time frame: 0-6 months
gingival recession
Change of Gengival recession from baseline to 12 months
Time frame: 0-12 months
gingival recession
4 secondary outcomes
FMPS
Time frame: 6 months
FMPS
Time frame: 12 months
FMBS
Time frame: 6 months
FMBS
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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. 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 soft bristle toothbrush and mechanical toothbrush in people with Recession, Gingival, run by Universita degli Studi di Genova at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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 Italy. 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?
Results are not available in the source record.
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?
Change of Gengival recession from baseline to 6 months (time frame: 0-6 months). The study lists 2 primary outcomes in all. 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 17 Jul 2023.