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3D Evaluation of Postoperative Edema After Third Molar Surgery

Primary Purpose

Molar, Third, Third Molar Surgery, Soft Tissue Swelling

Status
Recruiting
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy
Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)
Sponsored by
Implantology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar, Third focused on measuring Third molar surgery, Three-dimensional imaging, postoperative Pain, Quality of Life, Oral surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Implantology InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Postoperative Pain
Postoperative pain will be assessed by using a Visual Analogue Scale (VAS) for pain. The Visual Analogue Scale for Pain ranges from 0 that represents "no pain" at the left pole to 100 (100mm scale) which represents 'worst imaginable pain" at the right pole Immediately before surgery, a form will be given to each patient with the scale and they will be instructed to place a line perpendicular to the Visual Analogue Scale line at the point that represents their level of pain at different times: immediately before surgery (t0), at review appointments on postoperative days 2 (t2) and 7 (t7). They will be also instructed to record the type and frequency of rescue medication taken to manage their pain levels.
Patient's quality of life
To assess oral health-related quality of life and to better understand patients' experience during the recovery period after third molar surgery, a short-form derivative of the Oral Health Impact Profile-49, the OHIP-14 will be used. The validated portuguese version of the selfreported 14-item Oral Health Impact Profile (OHIP-14) questionnaire will be completed by the patients before surgery (t0) and at postoperative days 2 (t2) and 7 (t7). The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded as: never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4) using a 12-months recall period.

Full Information

First Posted
November 15, 2022
Last Updated
July 9, 2023
Sponsor
Implantology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05941130
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Implantology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories)
Intervention Type
Drug
Intervention Name(s)
Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy
Other Intervention Name(s)
CORT+NSAID
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)
Other Intervention Name(s)
NSAID
Intervention Description
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
Primary Outcome Measure Information:
Title
Facial swelling
Description
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)
Time Frame
7 postoperative days
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative pain will be assessed by using a Visual Analogue Scale (VAS) for pain. The Visual Analogue Scale for Pain ranges from 0 that represents "no pain" at the left pole to 100 (100mm scale) which represents 'worst imaginable pain" at the right pole Immediately before surgery, a form will be given to each patient with the scale and they will be instructed to place a line perpendicular to the Visual Analogue Scale line at the point that represents their level of pain at different times: immediately before surgery (t0), at review appointments on postoperative days 2 (t2) and 7 (t7). They will be also instructed to record the type and frequency of rescue medication taken to manage their pain levels.
Time Frame
7 postoperative days
Title
Patient's quality of life
Description
To assess oral health-related quality of life and to better understand patients' experience during the recovery period after third molar surgery, a short-form derivative of the Oral Health Impact Profile-49, the OHIP-14 will be used. The validated portuguese version of the selfreported 14-item Oral Health Impact Profile (OHIP-14) questionnaire will be completed by the patients before surgery (t0) and at postoperative days 2 (t2) and 7 (t7). The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded as: never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4) using a 12-months recall period.
Time Frame
7 postoperative days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duarte Marques, DDS PhD
Phone
+351 217 210 980
Email
d.marques@institutoimplantologia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Catarina Pinto, DDS
Email
anacatarina.pinto@institutoimplantologia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Caramês, DDS PhD
Organizational Affiliation
Implantology Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helena Francisco, DDS PhD
Organizational Affiliation
Implantology Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Catarina Pinto, DDS
Organizational Affiliation
Implantology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Implantology Institute
City
Lisbon
ZIP/Postal Code
1070-064
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duarte Marques, DDS, PhD
Phone
+351 217 210 980
Email
d.marques@institutoimplantologia.com
First Name & Middle Initial & Last Name & Degree
Catarina Pinto, DDS
Phone
+351 217 210 980
Email
anacatarina.pinto@institutoimplantologia.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

3D Evaluation of Postoperative Edema After Third Molar Surgery

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