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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636830
Other study ID # BR 001
Secondary ID
Status Completed
Phase N/A
First received July 5, 2012
Last updated July 5, 2012
Start date August 2011
Est. completion date March 2012

Study information

Verified date July 2012
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 20 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Toothbrush type
Evaluate the use of toothbrushes with bristles soft and medium

Locations

Country Name City State
Brazil Federal University of Rio Grande do Sul Porto Alegre Rio Grande do Sul

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
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