Dental CalculusPhase 2NCT00818376
Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
A Phase 2 study testing Dental prophylaxis in people with Dental Calculus and Tooth Discoloration, run by Lutheran University of Brazil.
Trial summary
The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Calculus, Tooth Discoloration
- What is being tested?
- Dental prophylaxis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Dec 2008
- Phase
- Phase 2
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-35 years
- Male
- No relevant medical conditions that could interfere on the periodontal health
- Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites
- Willingness to comply
Who cannot join
- Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination
- Oral mucosal lesions
- Smokers
- Need for antibiotic premedication
- History of hypersensitivity to chlorhexidine
- Any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses)
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- Individuals that wanted to give up the study
- Any acute process like allergic reaction to the product or gingival abcess
- Necessity to use of any antibiotic or anti-inflammatory
- Use of any other rinsing product farther the chlorhexidine's rinses
- Individuals who did any mechanical biofilm control
About this study
Official title: Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. The purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.
Read the detailed description
Test panel
The test panel will be recruited from the dental students of the Lutheran University of Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their medical and dental history. Written and oral explanations detailing the study purpose and design will be given for each subject. Subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. If the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers.
The following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar.
Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - Absence of calculus; 1 - Presence of calculus.
Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.
- Conditions
- Dental Calculus, Tooth Discoloration
- Being tested
- Dental prophylaxis
- Keywords
- Chlorhexidine, adverse effects, staining, dental calculus, dental plaque
- Medical subject headings
- Dental Calculus, Tooth Discoloration, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prophylaxisOther
Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Staining
Measured: 21 days
Secondary outcomes (1)
Dental calculus formation
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJun 2006
- Primary completionNov 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CalculusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lutheran University of Brazil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818376
- Sponsor's protocol ID
- LutheranUB
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zanatta FB, Antoniazzi RP, Rosing CK. Staining and calculus formation after 0.12% chlorhexidine rinses in plaque-free and plaque covered surfaces: a randomized trial. J Appl Oral Sci. 2010 Sep-Oct;18(5):515-21. doi: 10.1590/s1678-77572010000500015.
PubMed 21085810
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
- ClinicalTrials.gov ID
- NCT00818376
- Acronym / sponsor ID
- LutheranUB
- Conditions
- Dental Calculus, Tooth Discoloration
- Keywords
- Chlorhexidine, adverse effects, staining, dental calculus, dental plaque
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lutheran University of BrazilUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2009 (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 presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. The purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.
Detailed description
Test panel
The test panel will be recruited from the dental students of the Lutheran University of Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their medical and dental history. Written and oral explanations detailing the study purpose and design will be given for each subject. Subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. If the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers.
The following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar.
Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - Absence of calculus; 1 - Presence of calculus.
Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-35 years
- Male
- No relevant medical conditions that could interfere on the periodontal health
- Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites
- Willingness to comply
Key exclusion criteria (11 listed)
- Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination
- Oral mucosal lesions
- Smokers
- Need for antibiotic premedication
- History of hypersensitivity to chlorhexidine
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 |
|---|---|---|
| Dental prophylaxisTwo randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence. | Other | – |
Primary outcome
Dental Staining
Time frame: 21 days
1 secondary outcome
Dental calculus formation
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 21085810Zanatta FB, Antoniazzi RP, Rosing CK. Staining and calculus formation after 0.12% chlorhexidine rinses in plaque-free and plaque covered surfaces: a randomized trial. J Appl Oral Sci. 2010 Sep-Oct;18(5):515-21. doi: 10.1590/s1678-77572010000500015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dental prophylaxis in people with Dental Calculus and Tooth Discoloration, run by Lutheran University of 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 11 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: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Staining (time frame: 21 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 NCT00818376, which also lists 1 linked publication.
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 30 Jan 2009.