NCT01630837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

June 26, 2012

Last Update Submit

June 27, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • gingivitis expressed as an increase in mean gingival index in the experimental period

    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

    one month of evaluetion

Study Arms (4)

12h

OTHER

Frequency of oral hygiene was 12 to 12 hours.

Other: frequency of oral hygiene

24h

OTHER

Frequency of oral hygiene was 24 to 24 hours.

Other: frequency of oral hygiene

48h

OTHER

Frequency of oral hygiene was 48 to 48 hours.

Other: frequency of oral hygiene

72h

OTHER

Frequency of oral hygiene was 72 to 72 hours.

Other: frequency of oral hygiene

Interventions

the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.

12h24h48h72h

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • dental students
  • pregnant woman
  • diabetics
  • smokers
  • orthodontic equipment
  • antimicrobial prophylaxis
  • antibiotic
  • anti-inflammatory
  • psychomotor disturbances
  • periodontitis
  • PD ≥ 3mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Frequency of oral hygiene in the maintenace of gingival health

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations