GingivitisPhase 3NCT00471783
Flossing With Chlorhexidine
A Phase 3 study testing Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. in people with Gingivitis, run by University of British Columbia at 1 site in Canada.
Trial summary
To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Dec 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be considered for inclusion into the study, subjects must fulfill the following conditions:
- 18 years and older
- Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis
- Willing to floss every day and have the necessary dexterity to floss
- Have a minimum of 20 natural teeth, including 4 molars
- Have at least 10 bleeding sites
- Be a non-smoker
Who cannot join
- Subjects will be excluded from the study, if they have any of the following conditions:
- Pregnant or plan to be pregnant within the next 3 months
- Allergic to chlorhexidine or quinine sulphate
- Require pre-medication with antibiotics for dental treatment
- Currently taking antibiotics
- Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants
Show all 13Show fewer
- Currently using chlorhexidine or whitening products
- Have active carious lesions
- Have orthodontic braces
- Have more than 2 crowns or bridges
- Have more than 2 implants
- Have full or partial dentures
- Have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.
Read the detailed description
Purpose of study: To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Trial design: The study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial.
Randomization of subjects into study groups: Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects.
Trial schedule:
- Screening for potential subjects \& consent obtained. Calibration of examiner.
- Week -1: Professional prophylaxis consisting of scaling and polishing.
- Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI - flossing. Subject randomized into a study group.
- Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed.
- Week 12: Subjects reassessed for GI, SI, PI, BOP, PD. All floss boxes and logbook returned. Subject concerns or questions addressed. Subject exited from study and returned to the care of his or her regular dental professional.
Measurements for data collection (done in this order):
- Gingival index (GI) (modification of Löe \& Silness, 1963)
- Stain Index (SI)
- Plaque index (PI) (modification of Silness and Löe, 1964)
- Bleeding on Probing (BOP)
- Probing Depth (PD)
- Conditions
- Gingivitis
- Being tested
- Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
- Keywords
- gingivitis, chlorhexidine, dental floss, RCT, bleeding on probing, gingival and plaque indices
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Dental Hygiene Research and Education, British Columbia Dental Hygienists' Association (BCDHA)
- Investigators
- Donald Brunette, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471783
- Sponsor's protocol ID
- H05-70513
- Status last verified
- Aug 2008
- First submitted
- 8 May 2007
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00471783
- Acronym / sponsor ID
- H05-70513
- Conditions
- Gingivitis
- Keywords
- gingivitis, chlorhexidine, dental floss, RCT, bleeding on probing, gingival and plaque indices
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Foundation for Dental Hygiene Research and Education, British Columbia Dental Hygienists' Association (BCDHA)
- Study start
- Apr 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 May 2007 (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.
To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.
Detailed description
Purpose of study: To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Trial design: The study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial.
Randomization of subjects into study groups: Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects.
Trial schedule:
- Screening for potential subjects \& consent obtained. Calibration of examiner.
- Week -1: Professional prophylaxis consisting of scaling and polishing.
- Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI - flossing. Subject randomized into a study group.
- Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed.
- Week 12: Subjects reassessed for GI, SI, PI, BOP, PD. All floss boxes and logbook returned. Subject concerns or questions addressed. Subject exited from study and returned to the care of his or her regular dental professional.
Measurements for data collection (done in this order):
- Gingival index (GI) (modification of Löe \& Silness, 1963)
- Stain Index (SI)
- Plaque index (PI) (modification of Silness and Löe, 1964)
- Bleeding on Probing (BOP)
- Probing Depth (PD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be considered for inclusion into the study, subjects must fulfill the following conditions:
- 18 years and older
- Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis
- Willing to floss every day and have the necessary dexterity to floss
- Have a minimum of 20 natural teeth, including 4 molars
Key exclusion criteria (13 listed)
- Pregnant or plan to be pregnant within the next 3 months
- Allergic to chlorhexidine or quinine sulphate
- Require pre-medication with antibiotics for dental treatment
- Currently taking antibiotics
- Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants
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 |
|---|---|---|
| Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. | Procedure or surgery | – |
Primary outcome
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Time frame: 3 months
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 15 Aug 2008.
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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.
Donald Brunette, Ph.D principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. in people with Gingivitis, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 13 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 15 Aug 2008. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2008.