Frequency of Oral Hygiene

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tatiana Militz Perrone Pinto, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier:
NCT01630837
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of gingival health in patients with an adequate method of oral hygiene.


Condition Intervention
Gingivitis
Oral Health
Other: frequency of oral hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Frequency of Oral Hygiene in the Maintenance of Gingival Health

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Santa Maria:

Primary Outcome Measures:
  • gingivitis expressed as an increase in mean gingival index in the experimental period [ Time Frame: one month of evaluetion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in plaque levels and variations of the average percentage of sites with different GI scores during the study [ Time Frame: one month of evaluetion ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
12h
Frequency of oral hygiene was 12 to 12 hours.
Other: frequency of oral hygiene
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
24h
Frequency of oral hygiene was 24 to 24 hours.
Other: frequency of oral hygiene
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
48h
Frequency of oral hygiene was 48 to 48 hours.
Other: frequency of oral hygiene
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
72h
Frequency of oral hygiene was 72 to 72 hours.
Other: frequency of oral hygiene
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.

Detailed Description:

The study was a randomized blinded clinical trial. Eligible patients underwent a pre-clinical period in order to eliminate factors that could interfere with the proper plaque control. Forty-five non dental students with healthy gingival (maximum 5% of sites showing gingival bleeding) were randomized into four groups according to the frequency of oral hygiene (every 12h, 24h, 48h or 72h). Plaque Index (PLI) and Gingival Index (GI) were evaluated by two trained examiners at baseline, 15 days and 30 days.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • students of graduate courses at the Federal University of Santa Maria and Franciscan University Center
  • a minimum age of 18 years
  • filling all space interdental papilla
  • at least 24 teeth
  • maximum 15% of sites with gingivitis.

Exclusion Criteria:

  • dental students
  • pregnant woman
  • diabetics
  • smokers
  • orthodontic equipment
  • antimicrobial prophylaxis
  • antibiotic
  • anti-inflammatory
  • psychomotor disturbances
  • periodontitis
  • PD ≥ 3mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630837

Locations
Brazil
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Sponsors and Collaborators
Universidade Federal de Santa Maria
  More Information

No publications provided by Universidade Federal de Santa Maria

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tatiana Militz Perrone Pinto, Frequency of oral hygiene in the maintenace of gingival health, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT01630837     History of Changes
Other Study ID Numbers: FHB0186.0.243.000-10
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 28, 2014