Frequency of Self-performed Mechanical Control of Plaque

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02684682
• Other study ID #: 50208115.9.0000.5346
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2016
• Last updated: March 31, 2016
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: Universidade Federal de Santa Maria
• Contact: Juliana Maier
• Email: juumaier[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Gingivitis
• Oral Health

Intervention

Behavioral:
• Frequency of mechanical control of plaque (12h)
Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.
• Frequency of mechanical control of plaque (24h)
Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.
• Frequency of mechanical control of plaque (48h)
Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.

Locations

Country	Name	City	State
Brazil	Juliana Maier	Santa Maria	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline gingival index at 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.	No
Secondary	Changes from baseline plaque level at 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.	No
Secondary	Changes from volume of gingival fluid at 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.	No