Molar, ThirdPhase 4NCT05941130
3D Evaluation of Postoperative Edema After Third Molar Surgery
A Phase 4 study testing Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy and Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan) in people with Molar, Third and Third Molar Surgery, run by Implantology Institute at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Molar, Third, Third Molar Surgery, Soft Tissue Swelling
- What is being tested?
- Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy and Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2022to 30 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Catarina Pinto, DDS contact
Portugal1 site, 1 recruiting
- Recruiting
Implantology Institute
Lisbon, 1070-064
Duarte Marques, DDS, PhD, +351 217 210 980, d.marques@institutoimplantologia.com
Catarina Pinto, DDS, +351 217 210 980, anacatarina.pinto@institutoimplantologia.com
About this study
Official title: Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial
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.
Read the 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
- Being tested
- 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)
- Keywords
- Third molar surgery, Three-dimensional imaging, postoperative Pain, Quality of Life, Oral surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapyDrug
Also called CORT+NSAID
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
Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)Drug
Also called NSAID
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan) Receives: Drug: Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan) |
| Group B | Experimental | Patients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories) Receives: Drug: Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 postoperative days
Secondary outcomes (2)
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.
Measured: 7 postoperative days
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.
Measured: 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jul 2022
- Primary completion15 Oct 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar, ThirdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Caramês, DDS PhD, Study director, Implantology InstituteHelena Francisco, DDS PhD, Study chair, Implantology InstituteCatarina Pinto, DDS, Principal investigator, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941130
- Sponsor's protocol ID
- institutodeimplantologia
- Status last verified
- Jul 2023
- First submitted
- 15 Nov 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05941130
- Acronym / sponsor ID
- institutodeimplantologia
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)Patients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan) |
| Group B | Experimental | Drug: Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapyPatients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapyAlso: CORT+NSAIDFacial 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 | Group B |
| Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan)Also: NSAIDFacial 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 | Drug | Group A |
Primary outcome
Facial swelling
Time frame: 7 postoperative days
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)
2 secondary outcomes
Postoperative Pain
Time frame: 7 postoperative days
Patient's quality of life
Time frame: 7 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Molar, Third
Not yet recruitingObservational study
Accuracy of AI in Positional Classification Between Lower Third Molar and Mandibular Canal
As a Decision-support Tool During Preoperative Assessment
RecruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Pinto, DDS contact
João Caramês, DDS PhD study director
Implantology Institute
Helena Francisco, DDS PhD study chair
Implantology Institute
Catarina Pinto, DDS principal investigator
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy and Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan) in people with Molar, Third and Third Molar Surgery, run by Implantology Institute at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duarte Marques, DDS PhD (+351 217 210 980, d.marques@institutoimplantologia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial swelling (time frame: 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.