Clinical trial NCT04438434: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Impacted Third Molar Tooth
Healing Surgical Wounds
Keywords: Impacted Third Molar Tooth
Surgical wound healing
Bleeding
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: BMG Pharma
First posted: 2020-06-18
Enrollment: 57
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Healing Index (Laundry-Turnbull and Howley, modified by Pippi and coll. in 2015)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: UOC Maxillofacial Surgery and Odontology, University of Milan
state: Lombardy
Study officials:
affiliation: University of Milan
name: Giampietro Farronato, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Gianguido Cossellu, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahban SR, Garner WL. Fibroproliferative scars. Clin Plast Surg. 2003 Jan;30(1):77-89. doi: 10.1016/s0094-1298(02)00069-x.
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.
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.
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.
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.