Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis

Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04446533
• Other study ID #: Orto_BMG0703_PRD_June_2020
• 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

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

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.

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: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Gum
• Gingival Hemorrhage
• Hemorrhage
• Periodontal Pocket
• Periodontitis
• Pocket, Periodontal

Intervention

Drug:
• Hydrogen Peroxide and Hyaluronic acid filming formulation
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of BMG0703 will then be given to the patients 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).
• Chlorhexidine 0.2%
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of Chlorhexidine 0.2% will then be given to the patients 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).
• Placebo
Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of the placebo product will then be given to the patients 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).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	BMG PHARMA

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — 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, 7, 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.; Higher score means worse outcome; 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, 7, 30 days
Secondary	Change in Microbiological analysis	The DNA-Sorb-B (Sacace) nucleic acid extraction kit will be used for the extraction and purification of bacterial DNA from clinical samples. Bacterial genome extraction is performed on 500 microlitres of oral sample fluid obtained from each patient.; The molecular analysis, using Real Time PCR, involves the use of the KIT Periodontitis (PeriodontScreen Real-TM, Sacace), and in particular the following bacterial species will be researched: Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Tannerella forsythia, Porphyromonas endodontalis.; Periodontopathogenic bacteria are divided into high (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticle, Tannerella forsythia) and medium risk (Fusobacterium nucleatum, Prevotella Intermediate, Porphyromonas endodontalis). The results of the molecular analysis will be related to the clinical indices obtained from each patient.	0,3,7,30 days