NCT05941130

3D Evaluation of Postoperative Edema After Third Molar Surgery

Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Implantology Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Surgical removal of third molars is recognized as one of the most frequent procedures performed in oral surgery. Literature is rich in studies attempting to demonstrate the benefit of corticosteroids in third molar surgery, however the variety of methods, doses, routes and timing of administration has hampered the standardization of their use in light of best evidence. Also the use of 3D facial superimposition methodology to measure and analyze facial swelling after third molar surgery is a relatively new and promising technology.

Detailed description

Surgical removal of third molars is recognized as one of the most frequent procedures performed in oral surgery. It is estimated that more than 50% of the population experience problems with their third molars, including impaction or other pathologies. Usually, recovery from third molar surgical procedures is straightforward, however some immediate side effects can be expected such as discomfort (pain), edema and trismus that are resolved within a few days. These results from postoperative tissue inflammatory response which present individual variations. Depending on the intensity of these postoperative symptoms and the severity of inflammatory response, daily activities may be temporarily affected and patient's overall quality of life might be impaired. Factors as surgical technique, type of impaction, duration of the procedure, surgical complications and an inadequate pharmacotherapy may influence the severity of symptoms. Although edema and discomfort after the surgery cannot be completely eliminated, the possibility of reducing the frequency and severity of complications and improve patient's quality of life have been investigated. Synthetic corticosteroids are widely used in surgery to control and reduce the post-surgical inflammatory response and pain since they limit inflammation and edema by reducing vascular dilatation and fluids transudation Literature is rich in studies attempting to demonstrate the benefit of corticosteroids in third molar surgery, however the variety of methods, doses, routes and timing of administration has hampered the standardization of their use in light of best evidence. To maximize the effectiveness in controlling both pain and swelling it is described in literature the combination of both NSAID and corticosteroids after third molar surgery, nevertheless reluctance and controversy regarding their coadministration in oral surgery still exists. The use of 3D facial superimposition methodology to measure and analyze facial swelling after third molar surgery is a relatively new and promising technology that allows a high level of accuracy and a quantitative analysis of this outcome having a great potential to become the standard method for evaluating volumes and distances in facial and body anatomy.

Conditions

• Molar, Third
• Third Molar Surgery
• Soft Tissue Swelling
• Pain, Postoperative
• Quality of Life

Interventions

Type	Name	Description
DRUG	Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy	Facial swelling assessment with a tridimensional method, pain and patient's quality of life will be evaluated after impacted third molar surgery, when NSAID are prescribed either alone (group A) or in combination with a corticosteroid (group B).Patients will be randomized before surgery into two groups regarding postoperative anti-inflammatory prescription. Half will receive postoperative steroid anti-inflammatory
DRUG	Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)	Facial swelling assessment with a tridimensional method, pain and patient's quality of life will be evaluated after impacted third molar surgery, when NSAID are prescribed either alone (group A) or in combination with a corticosteroid (group B).Patients will be randomized before surgery into two groups regarding postoperative anti-inflammatory prescription. Half will receive postoperative non-steroid anti-inflammatory

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-10-15
• Completion: 2024-04-30
• First posted: 2023-07-12
• Last updated: 2023-07-12

Locations

1 site across 1 country: Portugal