Clinical trial NCT02684682: Frequency of Self-performed Mechanical Control of Plaque
Official title: Effect of Self-performed Mechanical Control of Plaque Frequency in Patients With Historic of Periodontitis and in Maintenance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingivitis
Oral Health
Keywords: Toothbrushing
Gingivitis
Dental Plaque
Periodontal Diseases
Clinical Trial
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 39
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline gingival index at 30, 60 and 90 days.
timeFrame: 30,60 and 90 days.
Secondary outcomes:
measure: Changes from baseline plaque level at 30,60 and 90 days.
timeFrame: 30,60 and 90 days.
measure: Changes from volume of gingival fluid at 30,60 and 90 days.
timeFrame: 30,60 and 90 days.
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Juliana Maier
state: RS
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Karla Z Kantorski
role: STUDY_DIRECTOR
References:
citation: Reiniger APP, Maier J, Wikesjo UME, Moreira CHC, Kantorski KZ. Correlation between dental plaque accumulation and gingival health in periodontal maintenance patients using short or extended personal oral hygiene intervals. J Clin Periodontol. 2021 Jun;48(6):834-842. doi: 10.1111/jcpe.13448. Epub 2021 Mar 23.
citation: Maier J, Reiniger APP, Sfreddo CS, Wikesjo UM, Kantorski KZ, Moreira CHC. Effect of self-performed mechanical plaque control frequency on gingival health in subjects with a history of periodontitis: A Randomized Clinical Trial. J Clin Periodontol. 2020 Jul;47(7):834-841. doi: 10.1111/jcpe.13297. Epub 2020 May 20.