Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes
Primary Purpose
Gingival Recession, Gingival Abrasion, Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Toothbrush type
Sponsored by
About this trial
This is an interventional diagnostic trial for Gingival Recession focused on measuring Gingival fissures, Gingival recession, Risk factors, Traumatic toothbrushing
Eligibility Criteria
Inclusion Criteria:
- have at least 20 teeth,
- negative history of periodontitis (CAL ≥ 3mm),
- good systemic health.
Exclusion Criteria:
- do not have orthodontic appliances or dental implants,
- absence of dental caries or restorations at cervical buccal surface.
Sites / Locations
- Federal University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control toothbrush
Test toothbrush
Arm Description
The participants will use a toothbrush with soft bristles.
The participants will use a toothbrush with medium bristles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03367481
First Posted
December 1, 2017
Last Updated
May 11, 2021
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03367481
Brief Title
Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes
Official Title
Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes: Crossover Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Gingival Abrasion, Wounds and Injuries
Keywords
Gingival fissures, Gingival recession, Risk factors, Traumatic toothbrushing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control toothbrush
Arm Type
Active Comparator
Arm Description
The participants will use a toothbrush with soft bristles.
Arm Title
Test toothbrush
Arm Type
Experimental
Arm Description
The participants will use a toothbrush with medium bristles.
Intervention Type
Device
Intervention Name(s)
Toothbrush type
Intervention Description
In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
Primary Outcome Measure Information:
Title
Gingival fissures associated with toothbrushing
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Toothbrush wear
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have at least 20 teeth,
negative history of periodontitis (CAL ≥ 3mm),
good systemic health.
Exclusion Criteria:
do not have orthodontic appliances or dental implants,
absence of dental caries or restorations at cervical buccal surface.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui V Oppermann, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
12. IPD Sharing Statement
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Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes
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