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

Primary Purpose

Impacted Third Molar Tooth, Healing Surgical Wounds

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid

Chlorhexidine mouthwash

Placebo product

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring Impacted Third Molar Tooth, Surgical wound healing, Bleeding

Eligibility Criteria

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

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

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

Hydrogen Peroxide and Hyaluronic acid mouthwash (BMG0703)

Chlorhexidine 0.2% mouthwash

Placebo product

Arm Description

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. 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 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.

Outcomes

Primary Outcome Measures

Healing Index (Laundry-Turnbull and Howley, modified by Pippi and coll. in 2015)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04438434

First Posted

June 16, 2020

Last Updated

June 16, 2020

Sponsor

University of Milan

Collaborators

BMG Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04438434

Brief Title

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

Official Title

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.

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

Collaborators

BMG Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 healing of post-extraction sites of wisdom teeth by film forming action.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impacted Third Molar Tooth, Healing Surgical Wounds

Keywords

Impacted Third Molar Tooth, Surgical wound healing, Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

The products will be packaged in such a way that they are not recognizable either by the operator or 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 on the basis of 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. The data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.

Allocation

Randomized

Enrollment

57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydrogen Peroxide and Hyaluronic acid mouthwash (BMG0703)

Arm Type

Experimental

Arm Description

Arm Title

Chlorhexidine 0.2% mouthwash

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo product

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid

Other Intervention Name(s)

BMG0703

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine mouthwash

Other Intervention Name(s)

Chlorhexidine 0.2%

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo product

Other Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Healing Index (Laundry-Turnbull and Howley, modified by Pippi and coll. in 2015)

Description

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chiara Occhipinti, Professor

Phone

+393339155689

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

IPD Sharing Plan Description

Data available upon request

Citations:

PubMed Identifier

12636218

Citation

Rahban SR, Garner WL. Fibroproliferative scars. Clin Plast Surg. 2003 Jan;30(1):77-89. doi: 10.1016/s0094-1298(02)00069-x.

Results Reference

background

PubMed Identifier

25867983

Citation

Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.

Results Reference

background

PubMed Identifier

17335366

Citation

Cosyn J, Sabzevar MM. Subgingival chlorhexidine varnish administration as an adjunct to same-day full-mouth root planing. II. Microbiological observations. J Periodontol. 2007 Mar;78(3):438-45. doi: 10.1902/jop.2007.060222.

Results Reference

background

PubMed Identifier

25709411

Citation

Lee CT, Zhang S, Leung YY, Li SK, Tsang CC, Chu CH. Patients' satisfaction and prevalence of complications on surgical extraction of third molar. Patient Prefer Adherence. 2015 Feb 10;9:257-63. doi: 10.2147/PPA.S76236. eCollection 2015.

Results Reference

background

PubMed Identifier

18088870

Citation

Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.

Results Reference

background

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

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