Efficacy of Different Toothbrushes and Hygiene Regimen

  • STATUS
    Recruiting
  • participants needed
    58
  • sponsor
    University of Nove de Julho
Updated on 19 February 2024
probe
cavity
gingivitis
caries
halitosis
gingival bleeding
plax mouthwash
colgate

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 ( = 0.05) and their performance at different times will be evaluated by the Mann-Whitney test ( = 0.05).

Details
Condition Dental Plaque, Halitosis
Age 12-17 years
Treatment Total 12 regimen, Toothbrushing alone
Clinical Study IdentifierNCT04216069
SponsorUniversity of Nove de Julho
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.