Gum DiseaseNCT01811615
Efficacy of New Alcohol Free Mouthrinses
A study testing alcohol-free experimental mouth rinse and alcohol-containing mouth rinsing in people with Gum Disease, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone. Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gum Disease
- What is being tested?
- alcohol-free experimental mouth rinse and alcohol-containing mouth rinsing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Feb 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants between 18 and 65 years
- no severe periodontitis
- informed consent
Who cannot join
- handicapped participants
- allergies against mouth rinses
Trial locations and contacts
1 site in 1 country.
Germany1 site
Witten/Herdecke University School of Dental Medicine
Witten, North Rhine-Westphalia, 58455
About this study
Official title: A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.
Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.
- Conditions
- Gum Disease
- Being tested
- alcohol-free experimental mouth rinse, alcohol-containing mouth rinsing
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcohol-free experimental mouth rinseOther
alcohol-containing mouth rinsingOther
| Study group | Role | What they receive |
|---|---|---|
| toothbrushing plus rinsing | Active comparator | 0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing Receives: Other: alcohol-containing mouth rinsing |
| alcohol-free experimental mouth rinse | Experimental | 0.06% CHX + 0.025% NaF plus toothbrushing Receives: Other: alcohol-free experimental mouth rinse |
| toothbrushing and rinsing | Experimental | 0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing Receives: Other: alcohol-free experimental mouth rinse |
| toothbrushing alone | No intervention | negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Proximal Plaque Index (MPPI)
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum DiseaseStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, PD Dr. A. Rainer Jordan, University of Witten/Herdecke
- Investigators
- Stefan Zimmer, Professor, Study director, Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811615
- Sponsor's protocol ID
- OHCMA-CHM-BUH-RHS-00633
- Status last verified
- Mar 2013
- First submitted
- 18 Jan 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
- ClinicalTrials.gov ID
- NCT01811615
- Acronym / sponsor ID
- OHCMA-CHM-BUH-RHS-00633
- Conditions
- Gum Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- First posted
- 14 Mar 2013 (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.
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.
Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| toothbrushing plus rinsing | Active comparator | Other: alcohol-containing mouth rinsing0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing |
| alcohol-free experimental mouth rinse | Experimental | Other: alcohol-free experimental mouth rinse0.06% CHX + 0.025% NaF plus toothbrushing |
| toothbrushing and rinsing | Experimental | Other: alcohol-free experimental mouth rinse0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing |
| toothbrushing alone | No intervention | –negative control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants between 18 and 65 years
- no severe periodontitis
- informed consent
Key exclusion criteria (2 listed)
- handicapped participants
- allergies against mouth rinses
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 |
|---|---|---|
| alcohol-free experimental mouth rinse | Other | alcohol-free experimental mouth rinse, toothbrushing and rinsing |
| alcohol-containing mouth rinsing | Other | toothbrushing plus rinsing |
Primary outcome
Modified Proximal Plaque Index (MPPI)
Time frame: Eight weeks
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 14 Mar 2013.
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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.
Stefan Zimmer, Professor study director
Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alcohol-free experimental mouth rinse and alcohol-containing mouth rinsing in people with Gum Disease, run by University of Witten/Herdecke at 1 site in Germany.
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 3 inclusion and 2 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 14 Mar 2013. 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 Germany. 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?
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?
Modified Proximal Plaque Index (MPPI) (time frame: Eight weeks). 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 14 Mar 2013.