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

Gingivitis Clinical Trial

Official title:

Efficacy of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Inflammation and Bleeding Caused by Gingivitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04438421
• Other study ID #: BMG0703_ORC_May 2019 v.0
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2020
• Est. completion date: July 2020

Study information

• Verified date: June 2020
• Source: University of Milan
• Contact: Chiara Occhipinti, Professor
• Phone: +393339155689
• Email: Chiara.Occhipinti[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Gum
• Gingivitis
• Hemorrhage

Intervention

Drug:
• 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.
• Chlorhexidine mouthwash
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.
• 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 re-evaluated after 3 days and after one month.

Locations

Country	Name	City	State
Italy	UOC Maxillofacial Surgery and Odontology, University of Milan	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Axelsson P, Nyström 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. — View Citation

Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View Citation

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. — View Citation

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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