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Efficacy of Different Toothbrushes and Hygiene Regimen

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ClinicalTrials.gov Identifier: NCT04216069
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Brief Summary:
To evaluate: 1) Evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. The Group 1 will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash, and the other Group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste; 2) The level of halitosis. Two calibrated and blinded examiners (Cohen Kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - IHOS and gingival bleeding index, with the aid of a WHO probe. For the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. At the next consultation, subjects will be assessed clinically for halitosis using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan), in addition to the evaluation of the tongue flap index (ISL), pH and salivary flow. The evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. Data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. The differences in the criteria evaluated will be submitted to Fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test (α = 0.05).

Condition or disease Intervention/treatment Phase
Dental Plaque Halitosis Other: Total 12 regimen Other: Toothbrushing alone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will not know to which group the participant belongs.
Primary Purpose: Prevention
Official Title: Clinical Research Study to Evaluate the Efficacy of a Regimen Commercially Available Versus Brush Alone on Established Plaque and Gingivitis on Adolescents
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Total 12 regimen group
This group will use the following procedure: Colgate Ultrasoft toothbrush, Colgate Total 12 toothpaste and Plax Mouthwash.
Other: Total 12 regimen

The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Subjects from the Group 1 will use a regimen with Colgate Total 12 toothpaste + Plax mouthwash + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.

There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.


Experimental: Tooth brushing alone group
This group will use Colgate Ultrasoft toothbrush and Colgate Cavity Protection toothpaste.
Other: Toothbrushing alone

The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Group 2 will use Colgate Cavity Protection Toothpaste + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.

There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products.





Primary Outcome Measures :
  1. Evaluation of change in biofilm index [ Time Frame: Baseline, after 1, 3 and 6 months of toothbrushing. ]
    The gingival health assessments will be performed through a visual examination for the determination of the visible plaque index, gingival bleeding and oral health at baseline as well as after the use of brush.


Secondary Outcome Measures :
  1. Change in halitosis index [ Time Frame: Baseline, after 1, 3 and 6 months of toothbrushing. ]
    Halitosis index using the portable BreathAlert™ sulfide monitor (Tanita Corporation, Japan).



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health;
  • Age 12 to 17;
  • Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.

Exclusion Criteria:

  • Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
  • Teeth with formation defects and dental crowding;
  • Periodontal disease (tooth mobility > 2 mm, pocket > 5 mm, gingivitis);
  • Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
  • Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
  • Pregnant volunteers;
  • Use of medications that alter gingival health, such as antibiotics, in the previous three months;
  • Use of mouthwash or toothpaste containing products for the control of biofilm;
  • Smokers;
  • Systemic disease (diabetes).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216069


Locations
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Brazil
Universidade Metropolitana de Santos Recruiting
Santos, SP, Brazil, 11045-401
Contact: Caroline M Moriyama, PhD    +55 13 32283400    caroline.cmm@hotmail.com   
Sponsors and Collaborators
University of Nove de Julho
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Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT04216069    
Other Study ID Numbers: Toothbrushes
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Plaque
Halitosis
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms