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.

NCT04438434 Phase 3 UNKNOWN

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.

Details

Lead sponsor	University of Milan
Phase	Phase 3
Status	UNKNOWN
Enrolment	57
Start date	2020-06
Completion	2020-07

Conditions

• Impacted Third Molar Tooth
• Healing Surgical Wounds

Interventions

• Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid
• Chlorhexidine mouthwash
• Placebo product

Primary outcomes

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

Countries

Italy