Frequency of Self-performed Mechanical Control of Plaque

March 31, 2016 updated by: Juliana Maier, Universidade Federal de Santa Maria

Effect of Self-performed Mechanical Control of Plaque Frequency in Patients With Historic of Periodontitis and in Maintenance

The purpose of this blind randomized clinical trial is to evaluate different frequencies in self-mechanical control of plaque in individuals with historic of periodontitis and in periodic and preventive maintenance in order to assess which frequencies are compatible with maintaining gingival health.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thirty nine subjects with at most 5% of the sites for GI= 2 (gingival health) will be randomized into three groups with different frequencies in self-mechanical control of plaque: Group 12 hours, 24 hours and 48 hours. The exams of plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level and gingival crevicular fluid will be performed at baseline, 15, 30, 60 and 90 days.

Study Type

Interventional

Enrollment (Anticipated)

39

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

  • Brazil
    • RS
      • Santa Maria, RS, Brazil, 97015-372

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

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with historic of periodontitis (loss of interproximal insertion ≥3mm in two or more non-adjacent teeth) treated in the Clinic of Postgraduate Periodontics at the Federal University of Santa Maria and included in the periodontal maintenance program;
  • Minimum age of 35;
  • Individuals with at least 12 teeth in the mouth;
  • Maximum of 15% of sites with gingivitis;
  • Maximum of 25% of sites with bleeding on probing.

Exclusion Criteria:

  • Smokers;
  • Pregnant women;
  • Individuals with dryness of the mouth (xerostomia);
  • Diabetics;
  • Psychomotor disturbances;
  • Orthodontic equipment;
  • Antimicrobial prophylaxis;
  • Individuals using any medication associated with gingival overgrowth;
  • Individuals that used antibiotic/anti -inflammatory in recent 3 months.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 12h Group
Intervention 'Frequency of mechanical control of plaque (12h)'
Behavioral: Frequency of mechanical control of plaque (12h)
Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.
Other: 24h Group
Intervention 'Frequency of mechanical control of plaque (24h)'
Behavioral: Frequency of mechanical control of plaque (24h)
Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.
Other: 48h Group
Intervention 'Frequency of mechanical control of plaque (48h)'
Behavioral: Frequency of mechanical control of plaque (48h)
Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline gingival index at 30, 60 and 90 days.
Time Frame: 30,60 and 90 days.
Assess how different frequencies of self-performed mechanical control of plaque interfere in gingival status.
30,60 and 90 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline plaque level at 30,60 and 90 days.
Time Frame: 30,60 and 90 days.
  • Assess how different frequencies of self-performed mechanical control of plaque interfere in the accumulation of supragingival biofilm.
  • Correlate changes in plaque levels with changes in gingival index.
30,60 and 90 days.
Changes from volume of gingival fluid at 30,60 and 90 days.
Time Frame: 30,60 and 90 days.
  • Assess how different frequencies of self-performed mechanical control of plaque interfere in the volume of gingival fluid.
  • Correlate volume of gingival fluid with GI scores and bleeding on probing scores.
30,60 and 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Santa Maria

Investigators

  • Study Director: Karla Z Kantorski, Universidade Federal de Santa Maria

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

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

February 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50208115.9.0000.5346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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