NCT02684682

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

February 10, 2016

Last Update Submit

March 31, 2016

Conditions

GingivitisOral Health

Keywords

ToothbrushingGingivitisDental PlaquePeriodontal DiseasesClinical Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Changes from baseline plaque level at 30,60 and 90 days.

    30,60 and 90 days.

  • Changes from volume of gingival fluid at 30,60 and 90 days.

    30,60 and 90 days.

Study Arms (3)

12h Group

OTHER

Intervention 'Frequency of mechanical control of plaque (12h)'

Behavioral: Frequency of mechanical control of plaque (12h)

24h Group

OTHER

Intervention 'Frequency of mechanical control of plaque (24h)'

Behavioral: Frequency of mechanical control of plaque (24h)

48h Group

OTHER

Intervention 'Frequency of mechanical control of plaque (48h)'

Behavioral: Frequency of mechanical control of plaque (48h)

Interventions

Frequency of mechanical control of plaque (12h)BEHAVIORAL

Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.

12h Group
Frequency of mechanical control of plaque (24h)BEHAVIORAL

Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.

24h Group
Frequency of mechanical control of plaque (48h)BEHAVIORAL

Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.

48h Group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juliana Maier

Santa Maria, Rio Grande do Sul, 97015-372, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33751652DERIVED

  • 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.

    PMID: 32315448DERIVED

MeSH Terms

Conditions

GingivitisDental PlaquePeriodontal Diseases

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Officials

  • Karla Z Kantorski

    Universidade Federal de Santa Maria

    STUDY DIRECTOR

Central Study Contacts

Juliana Maier

CONTACT

juumaier@gmail.com

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
Master in dental science with an emphasis on periodontics

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

June 1, 2017

Last Updated

April 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)