3D Evaluation of Postoperative Edema After Third Molar Surgery
Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJuly 12, 2023
July 1, 2023
1.3 years
November 15, 2022
July 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Facial swelling
To evaluate postoperative facial swelling after impacted third molar surgery by using a 3D facial scanner in two different groups: A-NSAID alone; B - corticosteroid + NSAID. Each patient will perform three sets of facial soft tissue evaluation: before surgery (t0); 2 days postoperatively (t2) and 7 days postoperatively (t7). The changes in facial soft tissue volume after surgery will be qualitatively and volumetrically evaluated by using the previously validated 3D assessment with a 3D facial scanner (Bellus3D, version 2.2.1; Inc. Los Gatos, CA, USA) connected to a smartphone (Xiaomi Mi A2 Lite, Android version 9) via USB. Facial swelling will be determined by quantifying volumetric changes by using the superposition methodology and the alignment by the best fit algorithm of the pre and postoperative images, with Geomagic® software (Geomagic Inc., North Carolina, USA)
7 postoperative days
Secondary Outcomes (2)
Postoperative Pain
7 postoperative days
Patient's quality of life
7 postoperative days
Study Arms (2)
Group A
EXPERIMENTALPatients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan)
Group B
EXPERIMENTALPatients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories)
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Implantology Institute
Lisbon, 1070-064, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
João Caramês, DDS PhD
Implantology Institute
- STUDY CHAIR
Helena Francisco, DDS PhD
Implantology Institute
- PRINCIPAL INVESTIGATOR
Catarina Pinto, DDS
Implantology Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2022
First Posted
July 12, 2023
Study Start
July 1, 2022
Primary Completion
October 15, 2023
Study Completion
April 30, 2024
Last Updated
July 12, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share