GingivitisPhase 2OML0113NCT02138552
Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo
A Phase 2 study testing Octenidine dihydrochloride in people with Gingivitis, run by Schülke & Mayr GmbH at 2 sites in Germany.
Trial summary
The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Octenidine dihydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2013to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild gingivitis (mean GI: 0.2 - 1.0)
- Patients with complete natural "Ramfjord-teeth" or their replacement teeth
- Caucasian
- Signed Informed Consent
Who cannot join
- Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
- Patients who require endocarditis prophylaxis for dental examination and treatment
- Caries requiring treatment (e.g. caries with cavity) or other oral diseases (incl. gingival hyperplasia, diseases of the oral mucosa, periodontal screening index PSI > 2)
- Patients with orthodontic appliances and removable dentures
- Patients treated with antibiotics less than 3 months prior to the baseline examination at V1 and/or such a treatment planned for the duration of the trial
- Patients chronically treated with steroids
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- Patients who suffer from xerostomia
- Patients who regularly smoke more than 10 cigarettes per day
- Patients who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure
- Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism)
- Pregnant or breastfeeding women
- Women with childbearing potential except those who fulfill the following criteria:
- Post-menopausal (12 month of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
- Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- Continuous and correct application of a contraception method with a Pearl Index < 1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
Dresden, 01307
Abteilung für Parodontologie in der Poliklinik für Zahnerhaltung und Parodontologie der Universität Würzburg
Würzburg, 97070
About this study
Official title: Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis
The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.
- Conditions
- Gingivitis
- Being tested
- Octenidine dihydrochloride, Placebo
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octenidine dihydrochlorideDrug
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
PlaceboDrug
Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
| Study group | Role | What they receive |
|---|---|---|
| OCT 0.1% vs. Placebo | Active comparator | 0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) Receives: Drug: Octenidine dihydrochloride; Drug: Placebo |
| OCT 0.15% vs. Placebo | Active comparator | 0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) Receives: Drug: Octenidine dihydrochloride; Drug: Placebo |
| OCT 2.0% vs. Placebo | Active comparator | 0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) Receives: Drug: Octenidine dihydrochloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
Measured: After 1 minute of rinsing
Secondary outcomes (4)
Mean plaque index (PI)
PI is measured at V2 (Verum/Placebo) and V4 (Placebo/Verum) in a blinded cross-over design
Measured: After 5 days of application
Change in mean gingival index (GI)
GI is measured at V1/V2 (Verum/Placebo) and V3/V4 (Placebo/Verum) in a blinded cross-over design
Measured: After 5 days of application
Evaluation of taste and flavour (questionnaire)
Measured: After 5 days of application
AEs and SAEs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schülke & Mayr GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katrin Lorenz, Dr., Study director, Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138552
- Sponsor's protocol ID
- 2013-002708-14
- Acronym
- OML0113
- Status last verified
- May 2014
- First submitted
- 11 Nov 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis
- ClinicalTrials.gov ID
- NCT02138552
- Acronym / sponsor ID
- OML0113 / 2013-002708-14
- Conditions
- Gingivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Schülke & Mayr GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 May 2014 (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 objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCT 0.1% vs. Placebo | Active comparator | Drug: Octenidine dihydrochloride, Drug: Placebo0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
| OCT 0.15% vs. Placebo | Active comparator | Drug: Octenidine dihydrochloride, Drug: Placebo0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
| OCT 2.0% vs. Placebo | Active comparator | Drug: Octenidine dihydrochloride, Drug: Placebo0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild gingivitis (mean GI: 0.2 - 1.0)
- Patients with complete natural "Ramfjord-teeth" or their replacement teeth
- Caucasian
- Signed Informed Consent
Key exclusion criteria (16 listed)
- Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
- Patients who require endocarditis prophylaxis for dental examination and treatment
- Caries requiring treatment (e.g. caries with cavity) or other oral diseases (incl. gingival hyperplasia, diseases of the oral mucosa, periodontal screening index PSI > 2)
- Patients with orthodontic appliances and removable dentures
- Patients treated with antibiotics less than 3 months prior to the baseline examination at V1 and/or such a treatment planned for the duration of the trial
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 |
|---|---|---|
| Octenidine dihydrochlorideMouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo | Drug | OCT 0.1% vs. Placebo, OCT 0.15% vs. Placebo, OCT 2.0% vs. Placebo |
| PlaceboMouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo | Drug | OCT 0.1% vs. Placebo, OCT 0.15% vs. Placebo, OCT 2.0% vs. Placebo |
Primary outcome
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
Time frame: After 1 minute of rinsing
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
4 secondary outcomes
Mean plaque index (PI)
Time frame: After 5 days of application
Change in mean gingival index (GI)
Time frame: After 5 days of application
Evaluation of taste and flavour (questionnaire)
Time frame: After 5 days of application
AEs and SAEs
Time frame: 4 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 May 2014.
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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.
Katrin Lorenz, Dr. study director
Poliklinik für Parodontologie Med. Fakultät C. G. Carus der TU Dresden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octenidine dihydrochloride in people with Gingivitis, run by Schülke & Mayr GmbH at 2 sites 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 4 inclusion and 16 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application (time frame: After 1 minute of rinsing). 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 May 2014.