GingivitisNCT02684682
Frequency of Self-performed Mechanical Control of Plaque
A study of Gingivitis and Oral Health, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Gingivitis, Oral Health
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Smokers;
- Pregnant women;
- Individuals with dryness of the mouth (xerostomia);
- Diabetics;
- Psychomotor disturbances;
- Orthodontic equipment;
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- Antimicrobial prophylaxis;
- Individuals using any medication associated with gingival overgrowth;
- Individuals that used antibiotic/anti -inflammatory in recent 3 months.
Trial locations and contacts
1 site in 1 country.
Juliana Maier contact
Brazil1 site, 1 recruiting
- Recruiting
Juliana Maier
Santa Maria, Rio Grande do Sul, 97015-372
Juliana Maier, juumaier@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis, Oral Health
- Being tested
- Frequency of mechanical control of plaque (12h), Frequency of mechanical control of plaque (24h), Frequency of mechanical control of plaque (48h)
- Keywords
- Toothbrushing, Gingivitis, Dental Plaque, Periodontal Diseases, Clinical Trial
- Medical subject headings
- Gingivitis, Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency of mechanical control of plaque (12h)Behavioural
Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.
Frequency of mechanical control of plaque (24h)Behavioural
Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.
Frequency of mechanical control of plaque (48h)Behavioural
Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.
| Study group | Role | What they receive |
|---|---|---|
| 12h Group | Other | Intervention 'Frequency of mechanical control of plaque (12h)' Receives: Behavioral: Frequency of mechanical control of plaque (12h) |
| 24h Group | Other | Intervention 'Frequency of mechanical control of plaque (24h)' Receives: Behavioral: Frequency of mechanical control of plaque (24h) |
| 48h Group | Other | Intervention 'Frequency of mechanical control of plaque (48h)' Receives: Behavioral: Frequency of mechanical control of plaque (48h) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30,60 and 90 days.
Secondary outcomes (2)
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.
Measured: 30,60 and 90 days.
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.
Measured: 30,60 and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Maier, Universidade Federal de Santa Maria
- Investigators
- Karla Z Kantorski, Study director, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684682
- Sponsor's protocol ID
- 50208115.9.0000.5346
- Status last verified
- Mar 2016
- First submitted
- 10 Feb 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33751652Maier 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.
PubMed 32315448
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-performed Mechanical Control of Plaque Frequency in Patients With Historic of Periodontitis and in Maintenance
- ClinicalTrials.gov ID
- NCT02684682
- Acronym / sponsor ID
- 50208115.9.0000.5346
- Conditions
- Gingivitis, Oral Health
- Keywords
- Toothbrushing, Gingivitis, Dental Plaque, Periodontal Diseases, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12h Group | Other | Behavioral: Frequency of mechanical control of plaque (12h)Intervention 'Frequency of mechanical control of plaque (12h)' |
| 24h Group | Other | Behavioral: Frequency of mechanical control of plaque (24h)Intervention 'Frequency of mechanical control of plaque (24h)' |
| 48h Group | Other | Behavioral: Frequency of mechanical control of plaque (48h)Intervention 'Frequency of mechanical control of plaque (48h)' |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Smokers;
- Pregnant women;
- Individuals with dryness of the mouth (xerostomia);
- Diabetics;
- Psychomotor disturbances;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency of mechanical control of plaque (12h)Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device. | Behavioural | 12h Group |
| Frequency of mechanical control of plaque (24h)Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device. | Behavioural | 24h Group |
| Frequency of mechanical control of plaque (48h)Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device. | Behavioural | 48h Group |
Primary outcome
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.
2 secondary outcomes
Changes from baseline plaque level at 30,60 and 90 days.
Time frame: 30,60 and 90 days.
Changes from volume of gingival fluid at 30,60 and 90 days.
Time frame: 30,60 and 90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Derived from this study: PubMed 33751652Reiniger 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.
- Derived from this study: PubMed 32315448Maier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana Maier contact
Karla Z Kantorski study director
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gingivitis and Oral Health, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Maier (juumaier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline gingival index at 30, 60 and 90 days. (time frame: 30,60 and 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684682, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.