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

Phase 3

• Conditions: Gingivitis; Bleeding Gum
• Interventions: Drug: Chlorhexidine mouthwash; Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid; Drug: Placebo

• Registration Number: NCT04438421
• Lead Sponsor: University of Milan

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-18
• Last Update Posted: 2020-06-18
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine 0.2%	Chlorhexidine mouthwash	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.
BMG0703	Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid	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.
Placebo Product	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Bleeding index	0, 3, 30 days	Subjects will undergo the measurement of bleeding index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.; Data will be collected based on four possible clinical conditions: Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding; Higher score means worse outcome.
Change in Plaque index	0, 3, 30 days	Subjects will undergo the measurement of plaque index according to Silness J \& Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.; Data will be collected based on four possible clinical conditions: Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface.; The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time.

Trial Locations

Locations (1)

UOC Maxillofacial Surgery and Odontology, University of Milan; 🇮🇹 Milan, Lombardy, Italy