Frequency of Oral Hygiene

Sponsor

Universidade Federal de Santa Maria (Other)

Overall Status

Completed

CT.gov ID

NCT01630837

Collaborator

(none)

Enrollment

Location

Arms

9.1

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis Oral Health	Other: frequency of oral hygiene	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Official Title:

Frequency of Oral Hygiene in the Maintenance of Gingival Health

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.
Other: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures

gingivitis expressed as an increase in mean gingival index in the experimental period [one month of evaluetion]

Secondary Outcome Measures

changes in plaque levels and variations of the average percentage of sites with different GI scores during the study [one month of evaluetion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Santa Maria	Santa Maria	Rio Grande do Sul	Brazil	97105-900

Sponsors and Collaborators

Universidade Federal de Santa Maria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

FHB0186.0.243.000-10

First Posted:

Jun 28, 2012

Last Update Posted:

Jun 28, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Gingivitis

Study Results

No Results Posted as of Jun 28, 2012