GingivitisNCT01630837
Frequency of Oral Hygiene
A study testing frequency of oral hygiene in people with Gingivitis and Oral Health, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Oral Health
- What is being tested?
- frequency of oral hygiene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- dental students
- pregnant woman
- diabetics
- smokers
- orthodontic equipment
- antimicrobial prophylaxis
Show all 11Show fewer
- antibiotic
- anti-inflammatory
- psychomotor disturbances
- periodontitis
- PD ≥ 3mm
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis, Oral Health
- Being tested
- frequency of oral hygiene
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frequency of oral hygieneOther
the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| 12h | Other | Frequency of oral hygiene was 12 to 12 hours. Receives: Other: frequency of oral hygiene |
| 24h | Other | Frequency of oral hygiene was 24 to 24 hours. Receives: Other: frequency of oral hygiene |
| 48h | Other | Frequency of oral hygiene was 48 to 48 hours. Receives: Other: frequency of oral hygiene |
| 72h | Other | Frequency of oral hygiene was 72 to 72 hours. Receives: Other: frequency of oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingivitis expressed as an increase in mean gingival index in the experimental period
Measured: one month of evaluetion
Secondary outcomes (1)
changes in plaque levels and variations of the average percentage of sites with different GI scores during the study
Measured: one month of evaluetion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Militz Perrone Pinto, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630837
- Sponsor's protocol ID
- FHB0186.0.243.000-10
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26823235Pinto 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.
PubMed 23909568
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Oral Hygiene in the Maintenance of Gingival Health
- ClinicalTrials.gov ID
- NCT01630837
- Acronym / sponsor ID
- FHB0186.0.243.000-10
- Conditions
- Gingivitis, Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12h | Other | Other: frequency of oral hygieneFrequency of oral hygiene was 12 to 12 hours. |
| 24h | Other | Other: frequency of oral hygieneFrequency of oral hygiene was 24 to 24 hours. |
| 48h | Other | Other: frequency of oral hygieneFrequency of oral hygiene was 48 to 48 hours. |
| 72h | Other | Other: frequency of oral hygieneFrequency of oral hygiene was 72 to 72 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- dental students
- pregnant woman
- diabetics
- smokers
- orthodontic equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frequency of oral hygienethe frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours. | Other | 12h, 24h, 48h, 72h |
Primary outcome
gingivitis expressed as an increase in mean gingival index in the experimental period
Time frame: one month of evaluetion
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 26823235de 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.
- Derived from this study: PubMed 23909568Pinto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frequency of oral hygiene in people with Gingivitis and Oral Health, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingivitis expressed as an increase in mean gingival index in the experimental period (time frame: one month of evaluetion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630837, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.