Clinical trial NCT04446533: Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis
Official title: Assessment of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Periodontitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontitis
Bleeding Gum
Pocket, Periodontal
Keywords: Periodontitis
Bleeding Gum
Periodontal Pocket
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: BMG Pharma
First posted: 2020-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following a professional oral hygiene session, subjects will be divided into three groups: BMG0703, active comparator a nd placebo.

First application of products will be applied clinically, and subsequently, one bottle of the product (test, comparative or placebo) will be given to the patient to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.

The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
Primary purpose: TREATMENT

Brief summary: Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of supragingival plaque, compared to Chlorhexidine and a placebo product

Detailed description: The enrolled subjects will be examined and treated by specialized medical personnel.

Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.

Next, subjects will be divided into three groups: after the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with the test product, active comparator or placebo, with the aid of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.

One bottle of the product (test, comparative or placebo) will then be given to the patient who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.

The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).

Patients with allergic reactions or hypersensitivity due to the use of the products will be advised to discontinue the use of the products and seek medical advice.

Eligibility criteria: Inclusion Criteria:

* Presence of periodontitis with pockets between 3 and 7 mm
* 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 pathologies
* 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, 7, 30 days
measure: Change in Plaque index
timeFrame: 0, 3, 7, 30 days
Secondary outcomes:
measure: Change in Microbiological analysis
timeFrame: 0,3,7,30 days
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: Caton J, Greenstein G, Polson AM. Depth of periodontal probe penetration related to clinical and histologic signs of gingival inflammation. J Periodontol. 1981 Oct;52(10):626-9. doi: 10.1902/jop.1981.52.10.626.
citation: Fowler C, Garrett S, Crigger M, Egelberg J. Histologic probe position in treated and untreated human periodontal tissues. J Clin Periodontol. 1982 Sep;9(5):373-85. doi: 10.1111/j.1600-051x.1982.tb02048.x.
citation: Polson AM, Caton JG, Yeaple RN, Zander HA. Histological determination of probe tip penetration into gingival sulcus of humans using an electronic pressure-sensitive probe. J Clin Periodontol. 1980 Dec;7(6):479-88. doi: 10.1111/j.1600-051x.1980.tb02154.x.
citation: Keagle JG, Garnick JJ, Searle JR, King GE, Morse PK. Gingival resistance to probing forces. I. Determination of optimal probe diameter. J Periodontol. 1989 Apr;60(4):167-71. doi: 10.1902/jop.1989.60.4.167.
citation: Hull PS, Clerehugh V, Ghassemi-Aval A. An assessment of the validity of a constant force electronic probe in measuring probing depths. J Periodontol. 1995 Oct;66(10):848-51. doi: 10.1902/jop.1995.66.10.848.