Clinical trial NCT04438421: Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gingivitis
Bleeding Gum
Keywords: Gingivitis
Bleeding
Plaque
Tartar
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Bleeding index
timeFrame: 0, 3, 30 days
measure: Change in Plaque index
timeFrame: 0, 3, 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: UOC Maxillofacial Surgery and Odontology, University of Milan
state: Lombardy
Study officials:
affiliation: University of Milan
name: Giampietro Farronato, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Gianguido Cossellu, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.3109/00016356408993968. No abstract available.
citation: 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.
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.
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. No abstract available.