Effect of Mouthrinsing on Inflammation of the Gums.

NCT ID: NCT01317446

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-01-31

Brief Summary

The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.

Detailed Description

Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

amine fluoride/stannous fluoride

Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene

Group Type: EXPERIMENTAL

amine fluoride/stannous fluoride

Intervention Type: DRUG

10 ml qd, oral, topical, 6 months duration

No rinsing

Mechanical oral hygiene only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

amine fluoride/stannous fluoride

10 ml qd, oral, topical, 6 months duration

Intervention Type: DRUG

Other Intervention Names

meridol

Eligibility Criteria

Inclusion Criteria

• Healthy male and female adults aged ≥18 years.
• Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites > 3.5 mm and < 5 mm).
• Participants must have read, understood and signed the informed consent form.
• Participants who have a GI ≥ 1.3 at baseline.
• Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).
• Participants who have an acceptable compliance according to the investigators' assessment.

Exclusion Criteria

• Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).
• Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).
• Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.
• Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.
• Participants who use other than the recommended mouthrinse or toothpaste during the study period.
• Participants who have moderate and severe chronic or aggressive periodontitis.
• Participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases.
• Participants who have rampant caries.
• Participants under guardianship or without freedom by administrative or legal award.
• Known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study.
• Known pregnancy or breast feeding during the course of the study.
• Participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaba International AG

INDUSTRY

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Hoffmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Dresden, Saxony, Germany

Countries

Germany

Other Identifiers

GASAS-1007X

Identifier Type: -

Identifier Source: org_study_id