Anti-gingivitis Mouthrinse

NCT06048627 | Completed Phase 3

• 1 other identifier: CRO-2022-10-MER-MW-JG
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Turesky Modification of the Quigley Hein Plaque Index (PI)

  Baseline, 3 weeks, 12 weeks, 24 weeks

• Intraoral scans

  Baseline, 3 weeks, 12 weeks, 24 weeks

• Patient-reported experiences

  Baseline, 3 weeks, 12 weeks, 24 weeks

Study Arms (2)

Mouthwash Test

ACTIVE COMPARATOR

Drug: Amine/zinc lactate/fluoride system

Mouthwash Experimental

EXPERIMENTAL

Drug: negative control

Interventions

Amine/zinc lactate/fluoride system DRUG

Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive

Mouthwash Test

negative control DRUG

Sodium fluoride mouthwash 250 ppm

Mouthwash Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Technische Universität Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 21, 2023
• Study Start: March 6, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 21, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)