Gingival RecessionNCT01636830
The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial
A study testing Toothbrush type in people with Gingival Recession and Wounds and Injuries, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, 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
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Mar 2012
- 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- good/ excellent health;
- idade de 14 a 20 anos;
- at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
- absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.
Who cannot join
- were unable to provide consent or comply with the sudy protocol;
- smokers;
- pregnant women;
- persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
- need of antibiotic prophylaxis associated with dental procedures.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035003
About this study
Official title: The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized
The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.
Read the detailed description
Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.
This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.
- Conditions
- Gingival Recession, Wounds and Injuries
- Being tested
- Toothbrush type
- Keywords
- Toothbrushing, gingival recession
- 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
Evaluate the use of toothbrushes with bristles soft and medium
| Study group | Role | What they receive |
|---|---|---|
| Toothbrush type - medium | Active comparator | This is a crossover study, where the person used either a soft brush (control) and the medium brush (test). Receives: Device: Toothbrush type |
| Toothbrush type - soft | Active comparator | This is a crossover study, where the person used either a soft brush (control)and the medium brush(test). 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
This study took standardized photographs every 2 or 3 days during two periods of 28 days for evaluation of gingival fissures. These were measured by application of a disclosing solution of plaque on teeth and gums of the participants. The application developer board is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Principal investigator, Bruna Frizon Greggianin, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636830
- Sponsor's protocol ID
- BR 001
- Status last verified
- Jul 2012
- First submitted
- 5 Jul 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Greggianin BF, Oliveira SC, Haas AN, Oppermann RV. The incidence of gingival fissures associated with toothbrushing: crossover 28-day randomized trial. J Clin Periodontol. 2013 Apr;40(4):319-26. doi: 10.1111/jcpe.12072. Epub 2013 Feb 21.
PubMed 23425194
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized
- ClinicalTrials.gov ID
- NCT01636830
- Acronym / sponsor ID
- BR 001
- Conditions
- Gingival Recession, Wounds and Injuries
- Keywords
- Toothbrushing, gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- 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 objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.
Detailed description
Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.
This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothbrush type - medium | Active comparator | Device: Toothbrush typeThis is a crossover study, where the person used either a soft brush (control) and the medium brush (test). |
| Toothbrush type - soft | Active comparator | Device: Toothbrush typeThis is a crossover study, where the person used either a soft brush (control)and the medium brush(test). |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- good/ excellent health;
- idade de 14 a 20 anos;
- at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
- absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.
Key exclusion criteria (5 listed)
- were unable to provide consent or comply with the sudy protocol;
- smokers;
- pregnant women;
- persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
- need of antibiotic prophylaxis associated with dental procedures.
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 typeEvaluate the use of toothbrushes with bristles soft and medium | Device | Toothbrush type - medium, Toothbrush type - soft |
Primary outcome
Gingival Fissures associated with toothbrushing
Time frame: 3 months
This study took standardized photographs every 2 or 3 days during two periods of 28 days for evaluation of gingival fissures. These were measured by application of a disclosing solution of plaque on teeth and gums of the participants. The application developer board is safe, without contra-indications in the literature and facilitates visualization of gingival lesions and plaque.
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 10 Jul 2012.
- Derived from this study: PubMed 23425194Greggianin BF, Oliveira SC, Haas AN, Oppermann RV. The incidence of gingival fissures associated with toothbrushing: crossover 28-day randomized trial. J Clin Periodontol. 2013 Apr;40(4):319-26. doi: 10.1111/jcpe.12072. Epub 2013 Feb 21.
- Website of the Federal University of Rio Grande do SulLink provided by the sponsor.
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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 Toothbrush type in people with Gingival Recession and Wounds and Injuries, 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 4 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: finished, as of the sponsor's last update on 10 Jul 2012. 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: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636830, which also lists 1 linked publication.
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 10 Jul 2012.