Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651723
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbrushes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbrushes a Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 of GF in young adults using manual and electric soft toothbrushes in a cross-over randomized clinical trial along 2 months
Detailed Description:
Sample
Sample Calculation The sample size calculation was based on the study by Greggianin et al 2013 considering the smallest differences between means present The result determined 28 participants in a crossover study with a significance level of 005 study power of 08 according to calculations performed on the website httphedwigmghharvardedusample_sizejsjs_crossover_quanthtml Considering an attrition rate of 20 the number of participants included should be 34
Recruitment Students duly enrolled in high school classes at Colégio Tiradentes Porto AlegreRS will be invited to participate in this study The sample will be recruited from the verbal invitation by the researchers in the classroom The invitation will contain the study objectives volunteer profile inclusion and exclusion criteria a summary of the research procedures as well as the risks and benefits that the study will bring to the participants and contact information for the researchers At the end of this invitation the students will receive the informed consent form for participants over the age of 18 or the parentguardian informed consent form ICF These terms must be returned signed within one week in case of interest in participating in the study The following week those interested in participating who return the terms will undergo a dental examination to confirm their inclusion in the study If eligible they will be scheduled to begin the study
Oral hygiene tools
Hand brushes toothbrushes with soft texture multi-strand small head and flat surface will be purchased by the researchers in the local market from the same manufacturer type and lot
Electric toothbrushes electric toothbrushes will be obtained in the local market from the same manufacturer type and lot In this study soft tips will be used with a small oval head multiple bristle flat and soft The electric toothbrushes have a straight flat handle and are waterproof
Toothpaste fluoride toothpastes with no therapeutic action of low abrasion containing silica will be distributed to the participants according to their consumption The dentifrices belonging to the same lot will be purchased by the researchers in the local market
Assessment procedures
Interview At the beginning of the study day 0 an interview will be conducted in which the participants will answer a questionnaire about their sociodemographic data and oral hygiene habits Frequency timing and predominant brushing technique as well as the type of toothbrush used and use of interdental plaque control devices will be recorded Estimated time and reason for toothbrush change will also be recorded At the end of the experimental phase the volunteers will answer a questionnaire about the perceived use of the brushes provided
Clinical Evaluation of Gingival Fissures A clinical examination to evaluate the presence of GF will be conducted on the buccal surfaces of all teeth except third molars After washing and lightly drying the teeth and gums a staining solution Basic Fuchsin 1 aqueous solution will be applied with a cotton tip After one minute the area will be washed with a jet of water and dried again to examine for the presence of GF The measurement of the GF will be performed with the aid of a North Carolina periodontal probe positioned following the path of the GF from the gingival margin to the most apical portion of the lesion The results observed will be recorded in a specific form prepared to register the path extension and location of the GF that appear during the study A trained examiner DGS will be responsible for assessing and recording the GF The examiner will be trained by a senior examiner RVO and calibrated to record the presence of GF by analyzing twenty randomized images of GF photographs from the study database and repeating these analyses at a one-week interval Agreement between assessments will be statistically tested using the Intraclass Correlation Index ICI and Kappa test Before the start of the study reproducibility values above 07 are expected
Periodontal Exam A clinical periodontal examination will be conducted on all teeth present except third molars Visible Plaque Index VPI and Gingival Bleeding Index GBI will be performed on buccal lingualpalatal and proximal sites Bleeding on Probing BoP Periodontal Probing Depth PPD and Clinical Attachment Loss CAL will be performed on 6 sites per tooth PPD and CAL will be measured in millimeters and rounded up when necessary using a North Carolina type probe Two calibrated examiners DGS M L B M will be responsible for the examinations Calibration will be performed prior to the start of the study the examiners will be trained to record VPI GBI and BoP and calibrated to record the PPD and CAL exams under the supervision of a senior researcher RVO Reproducibility of the PPD and CAL exams will be obtained from repeating the exams on 10 of the participants with a minimum interval of one hour Agreement between assessments will be statistically tested using the ICI and Kappa test Before the beginning of the study we expect reproducibility values above 07
Data Collection
The research consultations will be performed in the Colégio Tiradentes of the Military Brigade of Porto Alegre with the necessary facilities and approvals Thus a dental office unit bench for materials containing toilet and dental chair equipped with reflector triple syringe and spittoon will be used The preparation of the space will follow the biosafety guidelines of the Biosafety Working Group - UFRGS
Experimental Design
Pre-experimental procedures Participants will receive a dental prophylaxis with the aid of manual scaling for the removal of dental calculus and other retentive factors polishing of tooth surfaces with prophylactic paste rubber cup and floss 21 days before the start of the experimental phase
Experimental Period At the beginning of the study day 0 baseline the participants will answer questionnaire 1 followed by periodontal and then GF exams After that the participants will be allocated to one of the two experimental groups TG electric brushes CG manual brushes using a randomization table available at wwwrandomorgbr The randomization will be performed by a researcher not involved in the tests P D M A and the results will be stored in a sealed brown envelope The same researcher will then distribute the corresponding oral hygiene kits Participants will be informed to maintain their regular oral hygiene habits and instructed on how to operate the electric toothbrushes according to the manufacturers instructions New toothpaste will be provided as demand throughout the study upon return of the used tube Participants will be advised not to share the toothbrush and toothpaste with people in their household The clinical evaluation of the presence of GF will be performed at 15 and 30 days while periodontal clinical parameters will be measured on the 30th day At the end of the first experimental phase the kits used will be collected by the researchers and the participants will receive a new dental prophylaxis after which they will enter a 21-day wash out period where they should return to their regular oral hygiene habits At the end of this wash out period the second experimental phase will begin The participants will receive a new oral hygiene kit containing the second toothbrush The second phase of the study will follow the experimental sequence of the first phase and at the end they will return the oral hygiene kit receive a new dental prophylaxis and fill out the questionnaire about the perception of the use of the two brushes Photographs may be taken with the patients agreement for illustrative records of the study
Adverse Event Reporting and Stopping Rule Participants will be required to report during the study any adverse effects they may experience associated with the use of the oral hygiene kit In case of detection of attachment loss 3 mm treatment will be discontinued and the participant will be followed up until remission of the GF
Sample Calculation The sample size calculation was based on the study by Greggianin et al 2013 considering the smallest differences between means present The result determined 28 participants in a crossover study with a significance level of 005 study power of 08 according to calculations performed on the website httphedwigmghharvardedusample_sizejsjs_crossover_quanthtml Considering an attrition rate of 20 the number of participants included should be 34
Recruitment Students duly enrolled in high school classes at Colégio Tiradentes Porto AlegreRS will be invited to participate in this study The sample will be recruited from the verbal invitation by the researchers in the classroom The invitation will contain the study objectives volunteer profile inclusion and exclusion criteria a summary of the research procedures as well as the risks and benefits that the study will bring to the participants and contact information for the researchers At the end of this invitation the students will receive the informed consent form for participants over the age of 18 or the parentguardian informed consent form ICF These terms must be returned signed within one week in case of interest in participating in the study The following week those interested in participating who return the terms will undergo a dental examination to confirm their inclusion in the study If eligible they will be scheduled to begin the study
Oral hygiene tools
Hand brushes toothbrushes with soft texture multi-strand small head and flat surface will be purchased by the researchers in the local market from the same manufacturer type and lot
Electric toothbrushes electric toothbrushes will be obtained in the local market from the same manufacturer type and lot In this study soft tips will be used with a small oval head multiple bristle flat and soft The electric toothbrushes have a straight flat handle and are waterproof
Toothpaste fluoride toothpastes with no therapeutic action of low abrasion containing silica will be distributed to the participants according to their consumption The dentifrices belonging to the same lot will be purchased by the researchers in the local market
Assessment procedures
Interview At the beginning of the study day 0 an interview will be conducted in which the participants will answer a questionnaire about their sociodemographic data and oral hygiene habits Frequency timing and predominant brushing technique as well as the type of toothbrush used and use of interdental plaque control devices will be recorded Estimated time and reason for toothbrush change will also be recorded At the end of the experimental phase the volunteers will answer a questionnaire about the perceived use of the brushes provided
Clinical Evaluation of Gingival Fissures A clinical examination to evaluate the presence of GF will be conducted on the buccal surfaces of all teeth except third molars After washing and lightly drying the teeth and gums a staining solution Basic Fuchsin 1 aqueous solution will be applied with a cotton tip After one minute the area will be washed with a jet of water and dried again to examine for the presence of GF The measurement of the GF will be performed with the aid of a North Carolina periodontal probe positioned following the path of the GF from the gingival margin to the most apical portion of the lesion The results observed will be recorded in a specific form prepared to register the path extension and location of the GF that appear during the study A trained examiner DGS will be responsible for assessing and recording the GF The examiner will be trained by a senior examiner RVO and calibrated to record the presence of GF by analyzing twenty randomized images of GF photographs from the study database and repeating these analyses at a one-week interval Agreement between assessments will be statistically tested using the Intraclass Correlation Index ICI and Kappa test Before the start of the study reproducibility values above 07 are expected
Periodontal Exam A clinical periodontal examination will be conducted on all teeth present except third molars Visible Plaque Index VPI and Gingival Bleeding Index GBI will be performed on buccal lingualpalatal and proximal sites Bleeding on Probing BoP Periodontal Probing Depth PPD and Clinical Attachment Loss CAL will be performed on 6 sites per tooth PPD and CAL will be measured in millimeters and rounded up when necessary using a North Carolina type probe Two calibrated examiners DGS M L B M will be responsible for the examinations Calibration will be performed prior to the start of the study the examiners will be trained to record VPI GBI and BoP and calibrated to record the PPD and CAL exams under the supervision of a senior researcher RVO Reproducibility of the PPD and CAL exams will be obtained from repeating the exams on 10 of the participants with a minimum interval of one hour Agreement between assessments will be statistically tested using the ICI and Kappa test Before the beginning of the study we expect reproducibility values above 07
Data Collection
The research consultations will be performed in the Colégio Tiradentes of the Military Brigade of Porto Alegre with the necessary facilities and approvals Thus a dental office unit bench for materials containing toilet and dental chair equipped with reflector triple syringe and spittoon will be used The preparation of the space will follow the biosafety guidelines of the Biosafety Working Group - UFRGS
Experimental Design
Pre-experimental procedures Participants will receive a dental prophylaxis with the aid of manual scaling for the removal of dental calculus and other retentive factors polishing of tooth surfaces with prophylactic paste rubber cup and floss 21 days before the start of the experimental phase
Experimental Period At the beginning of the study day 0 baseline the participants will answer questionnaire 1 followed by periodontal and then GF exams After that the participants will be allocated to one of the two experimental groups TG electric brushes CG manual brushes using a randomization table available at wwwrandomorgbr The randomization will be performed by a researcher not involved in the tests P D M A and the results will be stored in a sealed brown envelope The same researcher will then distribute the corresponding oral hygiene kits Participants will be informed to maintain their regular oral hygiene habits and instructed on how to operate the electric toothbrushes according to the manufacturers instructions New toothpaste will be provided as demand throughout the study upon return of the used tube Participants will be advised not to share the toothbrush and toothpaste with people in their household The clinical evaluation of the presence of GF will be performed at 15 and 30 days while periodontal clinical parameters will be measured on the 30th day At the end of the first experimental phase the kits used will be collected by the researchers and the participants will receive a new dental prophylaxis after which they will enter a 21-day wash out period where they should return to their regular oral hygiene habits At the end of this wash out period the second experimental phase will begin The participants will receive a new oral hygiene kit containing the second toothbrush The second phase of the study will follow the experimental sequence of the first phase and at the end they will return the oral hygiene kit receive a new dental prophylaxis and fill out the questionnaire about the perception of the use of the two brushes Photographs may be taken with the patients agreement for illustrative records of the study
Adverse Event Reporting and Stopping Rule Participants will be required to report during the study any adverse effects they may experience associated with the use of the oral hygiene kit In case of detection of attachment loss 3 mm treatment will be discontinued and the participant will be followed up until remission of the GF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None