Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

University of Milan

Status and phase: Unknown; Phase 3

Conditions: Bleeding Gum; Gingivitis

Treatments: Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid; Drug: Chlorhexidine mouthwash; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04438421

BMG0703_ORC_May 2019 v.0

Details and patient eligibility

About

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.

Full description

50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group.

During the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to Silness J & Loe H 3,4. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged between 12 and 50 years
• Presence of gingivitis caused by accumulation of plaque/tartar
• Acceptance of informed consent

Exclusion criteria

• subjects suffering from HIV
• subjects suffering from hepatitis
• serious systemic diseases preventing the use of specific dental therapies
• acute and/or chronic infectious diseases
• inability to provide consent
• use of topical or systemic drugs
• inability to follow post-intervention hygiene instructions
• smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

BMG0703

Experimental group

Description:

Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.

Treatment:

Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid

Chlorhexidine 0.2%

Active Comparator group

Description:

Subjects will then be given a 0.2% Chlorhexidine product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.

Treatment:

Drug: Chlorhexidine mouthwash

Placebo Product

Placebo Comparator group

Description:

Subjects will then be given a placebo product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.

Treatment:

Drug: Placebo