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

Impacted Third Molar Tooth Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04438434
• Other study ID #: Orto_BMG0703_WIS_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

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healing Surgical Wounds
• Impacted Third Molar Tooth
• Surgical Wound
• Tooth, Impacted

Intervention

Drug:
• Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid
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.
• Chlorhexidine 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.

Other:
• 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.

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)

Araújo 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Rahban SR, Garner WL. Fibroproliferative scars. Clin Plast Surg. 2003 Jan;30(1):77-89. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days