- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630837
Frequency of Oral Hygiene
June 27, 2012 updated by: Tatiana Militz Perrone Pinto, Universidade Federal de Santa Maria
Frequency of Oral Hygiene in the Maintenance of Gingival Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Sul
-
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
- Federal University of Santa Maria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: 12h
Frequency of oral hygiene was 12 to 12 hours.
|
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.
|
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.
|
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.
|
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
gingivitis expressed as an increase in mean gingival index in the experimental period
Time Frame: one month of evaluetion
|
one month of evaluetion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
one month of evaluetion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- de Freitas GC, Pinto TM, Grellmann AP, Dutra DA, Susin C, Kantorski KZ, Moreira CH. Effect of self-performed mechanical plaque control frequency on gingival inflammation revisited: a randomized clinical trial. J Clin Periodontol. 2016 Apr;43(4):354-8. doi: 10.1111/jcpe.12520. Epub 2016 Mar 29.
- Pinto TM, de Freitas GC, Dutra DA, Kantorski KZ, Moreira CH. Frequency of mechanical removal of plaque as it relates to gingival inflammation: a randomized clinical trial. J Clin Periodontol. 2013 Oct;40(10):948-54. doi: 10.1111/jcpe.12135. Epub 2013 Aug 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
February 1, 2012
Study Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (ESTIMATE)
June 28, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 28, 2012
Last Update Submitted That Met QC Criteria
June 27, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHB0186.0.243.000-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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