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

Primary Purpose

Gingivitis, Bleeding Gum

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid
Chlorhexidine mouthwash
Placebo
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, Bleeding, Plaque, Tartar

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UOC Maxillofacial Surgery and Odontology, University of Milan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BMG0703

Chlorhexidine 0.2%

Placebo Product

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
June 16, 2020
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT04438421
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Bleeding Gum
Keywords
Gingivitis, Bleeding, Plaque, Tartar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMG0703
Arm Type
Experimental
Arm Description
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.
Arm Title
Chlorhexidine 0.2%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Product
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid
Other Intervention Name(s)
BMG0703
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
Chlorhexidine 0.2%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo product
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Bleeding index
Description
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.
Time Frame
0, 3, 30 days
Title
Change in Plaque index
Description
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.
Time Frame
0, 3, 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Occhipinti, Professor
Phone
+393339155689
Email
Chiara.Occhipinti@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giampietro Farronato, Professor
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gianguido Cossellu, Fellow
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC Maxillofacial Surgery and Odontology, University of Milan
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Protocol data available in PDF format upon request
Citations:
PubMed Identifier
15312097
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.
Results Reference
background
PubMed Identifier
14158464
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.
Results Reference
background
PubMed Identifier
5237684
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.
Results Reference
background
PubMed Identifier
28359280
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.
Results Reference
background
PubMed Identifier
21134231
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.
Results Reference
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Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

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