Clinical trial NCT05941130: 3D Evaluation of Postoperative Edema After Third Molar Surgery
Official title: Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Molar, Third
Third Molar Surgery
Soft Tissue Swelling
Pain, Postoperative
Quality of Life
Keywords: Third molar surgery
Three-dimensional imaging
postoperative Pain
Quality of Life
Oral surgery
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial swelling
timeFrame: 7 postoperative days
Secondary outcomes:
measure: Postoperative Pain
timeFrame: 7 postoperative days
measure: Patient's quality of life
timeFrame: 7 postoperative days
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Implantology Institute
Study officials:
affiliation: Implantology Institute
name: João Caramês, DDS PhD
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Helena Francisco, DDS PhD
role: STUDY_CHAIR
affiliation: Implantology Institute
name: Catarina Pinto, DDS
role: PRINCIPAL_INVESTIGATOR
References: