Frequency of Oral Hygiene

Gingivitis Clinical Trial

Official title:

Frequency of Oral Hygiene in the Maintenance of Gingival Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630837
• Other study ID #: FHB0186.0.243.000-10
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: June 27, 2012
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Gingivitis
• Oral Health

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingivitis expressed as an increase in mean gingival index in the experimental period		one month of evaluetion	No
Secondary	changes in plaque levels and variations of the average percentage of sites with different GI scores during the study		one month of evaluetion	No