Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
All Genders
NCT06458478

Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery

Led by Azienda Ospedaliera di Perugia · Updated on 2024-06-13

72

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage. The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).

CONDITIONS

Official Title

Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery

Who Can Participate

Age: 18Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Good overall and local health conditions
  • Age between 18 and 35 years
  • Understanding of the Italian language
  • Indicated for extraction of impacted bilateral lower third molars (teeth 38 and 48) based on Winter and Pell & Gregory classifications
  • Fully formed roots of impacted third molars
Not Eligible

You will not qualify if you...

  • Diabetes mellitus
  • Systemic arterial hypertension
  • Hyperthyroidism
  • Osteoporosis
  • Immunosuppression
  • Osteonecrosis of the jaws
  • Pregnancy
  • Mandibular third molars in position C according to Pell & Gregory Classification requiring surgery
  • Local problems such as pericoronitis, odontogenic cysts, or tumors near third molars
  • Allergies
  • Regular use of analgesics or antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ospedale Santa Maria della Misericordia

Perugia, Italy, 06156

Actively Recruiting

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Research Team

V

valeria mitro, Dr

CONTACT

M

Massimiliano Gilli, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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