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

NCT04438421 | Unknown Phase 3

• 1 other identifier: BMG0703_ORC_May 2019 v.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Bleeding Gum

Keywords

Gingivitis; Bleeding; Plaque; Tartar

Outcome Measures

Primary Outcomes (2)

• Change in Bleeding index

  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.

  0, 3, 30 days

• Change in Plaque index

  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.

  0, 3, 30 days

Study Arms (3)

BMG0703

EXPERIMENTAL

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.

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

Chlorhexidine 0.2%

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine mouthwash

Placebo Product

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid DRUG

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.

Also known as: BMG0703

BMG0703

Chlorhexidine mouthwash DRUG

Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, 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.

Also known as: Chlorhexidine 0.2%

Chlorhexidine 0.2%

Placebo DRUG

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 re-evaluated after 3 days and after one month.

Also known as: Placebo product

Placebo Product

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

UOC Maxillofacial Surgery and Odontology, University of Milan

Milan, Lombardy, 20122, Italy

Location

Related Publications (5)

• Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.

  PMID: 15312097 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 BACKGROUND

• Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.

  PMID: 28359280 BACKGROUND

• van der Weijden F, Slot DE. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000. 2011 Feb;55(1):104-23. doi: 10.1111/j.1600-0757.2009.00337.x. No abstract available.

  PMID: 21134231 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Gingival Hemorrhage; Hemorrhage; Plaque, Amyloid; Dental Calculus

Interventions

Hydrogen Peroxide; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Dental Deposits; Tooth Diseases; Calculi

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Giampietro Farronato, Professor

  University of Milan

  PRINCIPAL INVESTIGATOR

• Gianguido Cossellu, Fellow

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Occhipinti, Professor

CONTACT

+393339155689; Chiara.Occhipinti@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 50 subjects affected with gingivitis, caused by accumulation of plaque and/or tartar, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated to either the test group or the control group.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)