3D Evaluation of Postoperative Edema After Third Molar Surgery

Implantology Institute

Status and phase: Enrolling; Phase 4

Conditions: Quality of Life; Third Molar Surgery; Pain, Postoperative; Soft Tissue Swelling; Molar, Third

Treatments: Drug: Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan); Drug: Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05941130

institutodeimplantologia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals requiring surgical extraction of fully or partially impacted third molars requiring osteotomy;
• Individuals classified as grade I or II of the American Society of Anesthesiologists (ASA)
• Individuals with compliance to cooperate with the research protoco

Exclusion criteria

• Individuals with active bleeding or coagulation disorders
• Individuals with history of intolerance or hypersensitivity to the drugs included in the postoperative medication protocol
• Pregnant or lactating women
• Individuals with cysts or tumors around the embedded third molar
• Individuals who did not attend the control visits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group A

Experimental group

Description:

Patients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan)

Treatment:

Drug: Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)

Group B

Experimental group

Description:

Patients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories)

Treatment:

Drug: Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy