Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites

June 16, 2020 updated by: Chiara Occhipinti, University of Milan

Evaluation of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in Promoting the Healing of Post-extraction Sites, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the healing of post-extraction sites of wisdom teeth by film forming action.

Study Overview

Detailed Description

57 subjects, with an indication for a third molar extraction, will be enrolled in the study. Participants selection will take place at the IRCCS "Ca" Granda Ospedale Maggiore Policlinico of Milan - UOC Surgery Maxillo Facial and Dentistry where the internship activity of the Degree Course in Dentistry and Dental Prosthetics, Dental Hygiene and the School of Specialization in Orthodontics of the University of Milan is held.

Subsequently, subjects will be equally divided and randomly assigned into the test or control groups. Assessment of outcomes will be carried out at a distance of 7 days.

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • UOC Maxillofacial Surgery and Odontology, University of Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acceptance of informed consent
  • Need to carry out extraction of a third molar in total or partial impaction

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrogen Peroxide and Hyaluronic acid mouthwash (BMG0703)

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

The treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

The treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.

Other Names:
  • BMG0703
Active Comparator: Chlorhexidine 0.2% mouthwash

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

Subjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice.

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

Subjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice.

Other Names:
  • Chlorhexidine 0.2%
Placebo Comparator: Placebo product

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

Subjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.

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

The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.

From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.

Subjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).

Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice.

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing Index (Laundry-Turnbull and Howley, modified by Pippi and coll. in 2015)
Time Frame: 7 days

For evaluation of healing, the Laundry-Turnbull and Howley index will be used, considering the changes made by Pippi and coll. in 2015. In particular, seven parameters will be evaluated; a value of 1 or 0 will be assigned to each of these parameters; the sum of the values will indicate the degree of healing to be subsequently compared between the different groups.

In particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups.

These seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation.

Higher score means worse outcome.

7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Giampietro Farronato, Professor, University of Milan
  • Principal Investigator: Gianguido Cossellu, Fellow, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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