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

NCT03378401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-11-06

No results posted yet for this study

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)

Interventions

DRUG

Octenidinedihydrochlorid

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Schülke & Mayr GmbH

    lead INDUSTRY

Principal Investigators

  • Yvonne Jockel-Schneider, Dr.med.dent. · Universitätsklinikum Würzburg, Poliklinik für Zahnerhaltung und Parodontologie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2018-09-14
Completion
2018-09-14

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378401 on ClinicalTrials.gov