Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)Phase 3NCT03378401
Study to Assess the Inhibition of Plaque Formation in Subjects With a Gingival Index ≤1.5
A Phase 3 study testing Octenidinedihydrochlorid in people with Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5), run by Schülke & Mayr GmbH at 3 sites in 2 countries.
Trial summary
The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)
- What is being tested?
- Octenidinedihydrochlorid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Jan 2018to 14 Sep 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female subjects (aged 18 and older);
- Subjects with a total mean gingival index1 (GI, Löe, 1967) ≤1.5 (0.0-1.5);
- Subjects with at least 20 teeth (excluding wisdom teeth) with complete natural "Ramfjord-teeth" or their replacement teeth and 10 natural anterior teeth (excluding teeth provided with prosthetics such as crowns, dental bridges, veneers or large vestibular fillings such as large cervical or frontal teeth fillings; teeth with small interdental and orally oriented fillings are allowed);
- Non-pigmented gingiva;
- Signed informed consent.
Who cannot join
- Subjects with severe systemic diseases (e.g. hepatitis, human immunodeficiency virus [HIV] infection, tuberculosis, acute cancer treatment);
- Subjects who require endocarditis prophylaxis for dental examination and treatment;
- Subjects with caries requiring treatment (e.g. caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
- Subjects who have a history of chronic or aggressive periodontitis;
- Subjects with current moderate or severe chronic or aggressive periodontitis (periodontal screening index [PSI] >2 in more than 2 sextants or PSI >3);
- Subjects showing a GI score of 3 on at least one tooth;
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- Subjects who underwent oral surgery within 14 days prior to Screening;
- Subjects who used antiseptic mouth rinse within 14 days prior to Screening;
- Subjects wearing orthodontic appliances and removable dentures (Wire-retainers after orthodontic treatment are allowed);
- Subjects treated with antibiotics less than 3 months prior to the baseline examination at Visit 1 and/or planning such treatment for the duration of the study;
- Subjects treated with systemically acting corticosteroids or corticosteroids applied via the oral cavity (e.g. asthma sprays);
- Subjects who suffer from xerostomia;
- Subjects 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 subject in another clinical study within the last 4 weeks before enrolment in and during this study;
- Incapability of assessing essence and possible consequences of the study (e.g. alcoholism);
- Pregnant or breastfeeding women;
- Women with childbearing potential except those who fulfill one of the following criteria:
- Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum follicle-stimulating hormone [FSH] >40 U/ml);
- Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy);
- Continuous and correct application of a highly effective contraception method with a Pearl Index <1% (e.g. implants, depots, oral contraceptives, intrauterine device [IUD]);
- Sexual abstinence; whereas sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject;
- Confirmation of vasectomy of the sexual partner;
- Evidence suggesting that the subject is not likely to follow the study protocol (e.g. lacking compliance).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Poliklinik für Zahnerhaltung und Parodontologie der Universitätsklinik Köln
Cologne, North Rhine-Westphalia, 50931
Poliklinik für Zahnerhaltung und Parodontologie des Universitätsklinikums Würzburg
Würzburg, Bavaria, 97070
Austria1 site
Universitätszahnklinik Wien, Fachbereich Zahnerhaltung und Parodontologie
Vienna, 1090
About this study
Official title: Randomized, Placebo-controlled, Parallel Group, Double-blind, Multi-center Phase III Study to Assess the Inhibition of Plaque Formation of 0.1% Octenidine Mouthwash vs Placebo in Subjects With a Gingival Index ≤1.5
The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period.
- Being tested
- Octenidinedihydrochlorid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctenidinedihydrochloridDrug
Also called 0.1% Octenidine Mouthwash, OML
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
PlaceboOther
Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Octenidine Mouthwash | Experimental | 0.1% Octenidinedihydrochlorid Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days Receives: Drug: Octenidinedihydrochlorid |
| Placebo | Placebo comparator | Placebo Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2
The total mean PI is the sum of the individual scores divided by the number of investigated sites.
Measured: after 5 days of treatment
Secondary outcomes (5)
Bacterial count reduction in saliva after a single administration of OML vs placebo
Bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration
Measured: after 1 minute of rinsing
Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2
The total mean GI is the sum of the individual scores divided by the number of investigated sites. The GI for each tooth is the sum of the 4 individual scores divided by 4.
Measured: baseline and after 5 days of treatment
Incidence and severity of AEs (adverse events)
Measured: 5 days
Incidence of SAEs (serious adverse events)
Measured: 15 days
Change in tooth discoloration index from Visit 1 to Visit 2
Measured: baseline and after 5 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start11 Jan 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schülke & Mayr GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Jockel-Schneider, Dr.med.dent., Principal investigator, Universitätsklinikum Würzburg, Poliklinik für Zahnerhaltung und Parodontologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378401
- Sponsor's protocol ID
- OML-III-B
- Other IDs
- 2017-001698-18, 2017
- Status last verified
- Nov 2018
- First submitted
- 11 Dec 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Parallel Group, Double-blind, Multi-center Phase III Study to Assess the Inhibition of Plaque Formation of 0.1% Octenidine Mouthwash vs Placebo in Subjects With a Gingival Index ≤1.5
- ClinicalTrials.gov ID
- NCT03378401
- Acronym / sponsor ID
- OML-III-B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Schülke & Mayr GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 19 Dec 2017 (actual)
- 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 the study is to demonstrate the superiority of 0.1% octenidine mouthwash (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The study will consist of a 14-day screening period and a 5-day treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octenidine Mouthwash | Experimental | Drug: Octenidinedihydrochlorid0.1% Octenidinedihydrochlorid Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and female subjects (aged 18 and older);
- Subjects with a total mean gingival index1 (GI, Löe, 1967) ≤1.5 (0.0-1.5);
- Subjects with at least 20 teeth (excluding wisdom teeth) with complete natural "Ramfjord-teeth" or their replacement teeth and 10 natural anterior teeth (excluding teeth provided with prosthetics such as crowns, dental bridges, veneers or large vestibular fillings such as large cervical or frontal teeth fillings; teeth with small interdental and orally oriented fillings are allowed);
- Non-pigmented gingiva;
- Signed informed consent.
Key exclusion criteria (23 listed)
- Subjects with severe systemic diseases (e.g. hepatitis, human immunodeficiency virus [HIV] infection, tuberculosis, acute cancer treatment);
- Subjects who require endocarditis prophylaxis for dental examination and treatment;
- Subjects with caries requiring treatment (e.g. caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
- Subjects who have a history of chronic or aggressive periodontitis;
- Subjects with current moderate or severe chronic or aggressive periodontitis (periodontal screening index [PSI] >2 in more than 2 sextants or PSI >3);
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 |
|---|---|---|
| OctenidinedihydrochloridAlso: 0.1% Octenidine Mouthwash, OMLMouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days | Drug | Octenidine Mouthwash |
| PlaceboMouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days | Other | Placebo |
Primary outcome
Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2
Time frame: after 5 days of treatment
The total mean PI is the sum of the individual scores divided by the number of investigated sites.
5 secondary outcomes
Bacterial count reduction in saliva after a single administration of OML vs placebo
Time frame: after 1 minute of rinsing
Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2
Time frame: baseline and after 5 days of treatment
Incidence and severity of AEs (adverse events)
Time frame: 5 days
Incidence of SAEs (serious adverse events)
Time frame: 15 days
Change in tooth discoloration index from Visit 1 to Visit 2
Time frame: baseline and after 5 days of treatment
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 6 Nov 2018.
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.
Yvonne Jockel-Schneider, Dr.med.dent. principal investigator
Universitätsklinikum Würzburg, Poliklinik für Zahnerhaltung und Parodontologie
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octenidinedihydrochlorid in people with Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5), run by Schülke & Mayr GmbH at 3 sites in 2 countries.
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 23 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Austria. 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. Some participants in this study may receive a placebo. 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?
Total mean PI (Plaque index according to Silness and Löe) after 5 days of treatment at Visit 2 (time frame: after 5 days of treatment). 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 6 Nov 2018.