Study to Assess the Inhibition of Plaque Formation in Subjects With a Gingival Index ≤1.5

NCT03378401 | Completed Phase 3 DMC

• 2 other identifiers: OML-III-B2017-001698-18
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)

Outcome Measures

Primary Outcomes (1)

• 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.

  after 5 days of treatment

Secondary Outcomes (5)

• Bacterial count reduction in saliva after a single administration of OML vs placebo

  after 1 minute of rinsing

• Change in total mean GI (Gingival Index according to Löe, 1967) from Visit 1 to Visit 2

  baseline and after 5 days of treatment

• Incidence and severity of AEs (adverse events)

  5 days

• Incidence of SAEs (serious adverse events)

  15 days

• Change in tooth discoloration index from Visit 1 to Visit 2

  baseline and after 5 days of treatment

Study Arms (2)

Octenidine Mouthwash

EXPERIMENTAL

0.1% Octenidinedihydrochlorid Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days

Drug: Octenidinedihydrochlorid

Placebo

PLACEBO COMPARATOR

Placebo Solution for oromucosal use, mouth rinse with 10 ml for 30 s, 10 applications over 5 days

Other: Placebo

Interventions

Octenidinedihydrochlorid DRUG

Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days

Also known as: 0.1% Octenidine Mouthwash, OML

Octenidine Mouthwash

Placebo OTHER

Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Schülke & Mayr GmbH: lead

Study Sites (3)

Universitätszahnklinik Wien, Fachbereich Zahnerhaltung und Parodontologie

Vienna, 1090, Austria

Location

Poliklinik für Zahnerhaltung und Parodontologie des Universitätsklinikums Würzburg

Würzburg, Bavaria, 97070, Germany

Location

Poliklinik für Zahnerhaltung und Parodontologie der Universitätsklinik Köln

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Study Officials

• Yvonne Jockel-Schneider, Dr.med.dent.

  Universitätsklinikum Würzburg, Poliklinik für Zahnerhaltung und Parodontologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: January 11, 2018
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

DE (2); AU (1)