Anti-gingivitis Mouthrinse

Gingivitis Clinical Trial

Official title:

Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048627
• Other study ID #: CRO-2022-10-MER-MW-JG
• Status: Recruiting
• Phase: Phase 3
• Start date: March 6, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Colgate Palmolive
• Contact: Katrin Lorenz, Dr
• Phone: 493514585938
• Email: katrin.lorenz[@]ukdd.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Availability for the six-month duration of the clinical research study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
• Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
• Signed Informed Consent Form.

Exclusion Criteria:

• Presence of orthodontic bands.
• Malign tumor(s) of the soft or hard tissues of the oral cavity.
• Antibiotic use any time during the one-month period prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Dental prophylaxis during the past two weeks prior to baseline examinations.
• History of allergies to oral care/personal care consumer products or their ingredients.
• On any prescription medicines that might interfere with the study outcome.
• An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Self-reported pregnant or lactating subjects.
• Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
• Participants who require antibiotic treatments for dental appointments.
• Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3).
• Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
• Smokers or/and users of tobacco products.
• Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Amine/zinc lactate/fluoride system
Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive
• negative control
Sodium fluoride mouthwash 250 ppm

Locations

Country	Name	City	State
Germany	Technische Universität Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole-mouth Mean Modified Gingival Index (MGI)	Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups.	Baseline, 3 weeks, 12 weeks, 24 weeks
Secondary	Turesky Modification of the Quigley Hein Plaque Index (PI)	Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index as difference from baseline to 24 weeks between the study groups and at each time-point.	Baseline, 3 weeks, 12 weeks, 24 weeks
Secondary	Intraoral scans	Quantitative changes & before/after imagery from intraoral scans	Baseline, 3 weeks, 12 weeks, 24 weeks
Secondary	Patient-reported experiences	Changes in participant-reported experience as determined through participant-questionnaire	Baseline, 3 weeks, 12 weeks, 24 weeks