Gingival RecessionNCT03367481
Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes
A study testing Toothbrush type in people with Gingival Recession and Gingival Abrasion, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Gingival Abrasion, Wounds and Injuries
- What is being tested?
- Toothbrush type
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Feb 2019to 16 Dec 2019
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have at least 20 teeth,
- negative history of periodontitis (CAL ≥ 3mm),
- good systemic health.
Who cannot join
- do not have orthodontic appliances or dental implants,
- absence of dental caries or restorations at cervical buccal surface.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes: Crossover Randomized Clinical Trial
Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. The major factors related to the GF occurrence are high daily brushing frequencies, excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of the toothbrushes bristles. Thus, in order to better understand the pathogenesis and progression of GF, this study aim to evaluate the incidence and behavior of GF in young adults using soft and medium brushes, in a cross-over randomized clinical trial along 6 months.
Read the detailed description
Material and Methods: A blinded crossover randomized clinical trial will be conducted with 20 patients from a school (Colégio Tiradentes da Brigada Militar) at Porto Alegre city, southern of Brazil. Patients, aged between 18 to 25 years old, having at least 20 teeth, without previous history of periodontitis [clinical attachment loss (CAL) ≥ 3mm], and good systemic health will be included if they do not have orthodontic appliances or dental implants, or dental caries or restorations at cervical surface. Data collection will performed by two trained, calibrated and blinded examiners, and will comprehend a brief interview regarding oral hygiene and deleterious habits, full-mouth exams (6 sites/tooth) of Plaque Index (PlI), Gingival Index (GI), Pocket Probing Depth (PPD), and CAL, and clinical photographs (from 1st and 2nd premolars and 1st molar area in all quadrants) under disclosing solution (2Tone®) to evaluate the presence of gingival fissures (GF). After baseline data collection the participants will be randomized in one of the experimental groups according the toothbrush bristles stiffness: G1) soft; or G2) medium. No oral hygiene instruction will be provided to groups, and the patients will not be informed about the type of brush that will be provided. Re-exams (PlI, GI and photographs) will be conducted at 30, 60, 90 days. At day 90 the 1st phase will be finished, and the participants will have a 10-days wash-out period. At day 100, the 2nd phase will start, and the participants will change the groups. Re-exams will be conducted at 130, 160, 190 days. At day 190, the study will be finished. The participants will be oriented to return the toothbrushes used at the end of each experimental phase.
Outcomes: The primary outcome will be the number of participants with GF observed over the study period. Also, the incidence, size and duration of the GF will be compared regarding the variables: type of bristle, self-reported toothbrushing frequency, toothbrush deformation, and deleterious habits. McNemar test will be used to compare the frequencies of patients with GF and the number of lesions observed both inter and intra-groups. Uni- and multivariate regression models will be conducted to determine associations between the outcome and independent variables. The mean number of new fissures, GF that decreased, and GF that stabilized over time will be compared inter-groups as secondary analysis. Intention-to-treat analysis will be conducted, considering the individual the unit of analysis and a α-error of 0.05.
- Conditions
- Gingival Recession, Gingival Abrasion, Wounds and Injuries
- Being tested
- Toothbrush type
- Keywords
- Gingival fissures, Gingival recession, Risk factors, Traumatic toothbrushing
- Medical subject headings
- Gingival Recession, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothbrush typeDevice
In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
| Study group | Role | What they receive |
|---|---|---|
| Control toothbrush | Active comparator | The participants will use a toothbrush with soft bristles. Receives: Device: Toothbrush type |
| Test toothbrush | Experimental | The participants will use a toothbrush with medium bristles. Receives: Device: Toothbrush type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival fissures associated with toothbrushing
Standardized photographs, under disclosing solution (2Tone®) from 1st and 2nd premolars and 1st molar area in all quadrants, will be taken at baseline and at days 30, 60, 90, 100, 130, 160 and 190 for evaluation of gingival fissures. The disclosing solution is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque. After, the photographs will be analyzed in an image software in order to determine the mean number of new fissures, fissures that decreased, and those that stabilized over time. If, at any time during the study a gingival fissure become greater than 3mm, the patients will stop the use of the specific toothbrush and will be follow until the regression of the lesion.
Measured: 6 months
Secondary outcomes (1)
Toothbrush wear
The participants will be oriented to return the toothbrushes used at the end of each experimental phase. The toothbrush deformation/wear will be investigated by comparing the dimensions of height, width and length, in anterior, middle and posterior parts of the toothbrush (measured with a digital caliper), before and after its use by the participants, in each phase of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start22 Feb 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Vicente Oppermann, Federal University of Rio Grande do Sul
- Investigators
- Rui V Oppermann, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367481
- Sponsor's protocol ID
- Gingival fissures study
- Status last verified
- May 2021
- First submitted
- 1 Dec 2017
- Last updated
- 14 May 2021
- 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 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes: Crossover Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03367481
- Acronym / sponsor ID
- Gingival fissures study
- Conditions
- Gingival Recession, Gingival Abrasion, Wounds and Injuries
- Keywords
- Gingival fissures, Gingival recession, Risk factors, Traumatic toothbrushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 8 Dec 2017 (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.
Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. The major factors related to the GF occurrence are high daily brushing frequencies, excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of the toothbrushes bristles. Thus, in order to better understand the pathogenesis and progression of GF, this study aim to evaluate the incidence and behavior of GF in young adults using soft and medium brushes, in a cross-over randomized clinical trial along 6 months.
Detailed description
Material and Methods: A blinded crossover randomized clinical trial will be conducted with 20 patients from a school (Colégio Tiradentes da Brigada Militar) at Porto Alegre city, southern of Brazil. Patients, aged between 18 to 25 years old, having at least 20 teeth, without previous history of periodontitis [clinical attachment loss (CAL) ≥ 3mm], and good systemic health will be included if they do not have orthodontic appliances or dental implants, or dental caries or restorations at cervical surface. Data collection will performed by two trained, calibrated and blinded examiners, and will comprehend a brief interview regarding oral hygiene and deleterious habits, full-mouth exams (6 sites/tooth) of Plaque Index (PlI), Gingival Index (GI), Pocket Probing Depth (PPD), and CAL, and clinical photographs (from 1st and 2nd premolars and 1st molar area in all quadrants) under disclosing solution (2Tone®) to evaluate the presence of gingival fissures (GF). After baseline data collection the participants will be randomized in one of the experimental groups according the toothbrush bristles stiffness: G1) soft; or G2) medium. No oral hygiene instruction will be provided to groups, and the patients will not be informed about the type of brush that will be provided. Re-exams (PlI, GI and photographs) will be conducted at 30, 60, 90 days. At day 90 the 1st phase will be finished, and the participants will have a 10-days wash-out period. At day 100, the 2nd phase will start, and the participants will change the groups. Re-exams will be conducted at 130, 160, 190 days. At day 190, the study will be finished. The participants will be oriented to return the toothbrushes used at the end of each experimental phase.
Outcomes: The primary outcome will be the number of participants with GF observed over the study period. Also, the incidence, size and duration of the GF will be compared regarding the variables: type of bristle, self-reported toothbrushing frequency, toothbrush deformation, and deleterious habits. McNemar test will be used to compare the frequencies of patients with GF and the number of lesions observed both inter and intra-groups. Uni- and multivariate regression models will be conducted to determine associations between the outcome and independent variables. The mean number of new fissures, GF that decreased, and GF that stabilized over time will be compared inter-groups as secondary analysis. Intention-to-treat analysis will be conducted, considering the individual the unit of analysis and a α-error of 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control toothbrush | Active comparator | Device: Toothbrush typeThe participants will use a toothbrush with soft bristles. |
| Test toothbrush | Experimental | Device: Toothbrush typeThe participants will use a toothbrush with medium bristles. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- have at least 20 teeth,
- negative history of periodontitis (CAL ≥ 3mm),
- good systemic health.
Key exclusion criteria (2 listed)
- do not have orthodontic appliances or dental implants,
- absence of dental caries or restorations at cervical buccal surface.
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 |
|---|---|---|
| Toothbrush typeIn this cross-over study, the participants will use either a soft brush (control) and the medium brush (test). | Device | Control toothbrush, Test toothbrush |
Primary outcome
Gingival fissures associated with toothbrushing
Time frame: 6 months
Standardized photographs, under disclosing solution (2Tone®) from 1st and 2nd premolars and 1st molar area in all quadrants, will be taken at baseline and at days 30, 60, 90, 100, 130, 160 and 190 for evaluation of gingival fissures. The disclosing solution is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque. After, the photographs will be analyzed in an image software in order to determine the mean number of new fissures, fissures that decreased, and those that stabilized over time. If, at any time during the study a gingival fissure become greater than 3mm, the patients will stop the use of the specific toothbrush and will be follow until the regression of the lesion.
1 secondary outcome
Toothbrush wear
Time frame: 6 months
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 14 May 2021.
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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.
Rui V Oppermann, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrush type in people with Gingival Recession and Gingival Abrasion, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 2 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 14 May 2021. 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 Brazil. 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?
Gingival fissures associated with toothbrushing (time frame: 6 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 14 May 2021.