Molar, ThirdNCT05924191
Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars
A study testing Photobiomodulation, Simulation Photobiomodulation and Corticosteroid in people with Molar, Third and Photobiomodulation, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar, Third, Photobiomodulation
- What is being tested?
- Photobiomodulation, Simulation Photobiomodulation and Corticosteroid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Nov 2023to 20 Jul 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who present retained lower third molars, according to the degree of surgical difficulty of the procedure and the anatomical position.The selected molars will be those classified according to classes II and III and/or B or C of Pell and Gregory Classification; in vertical or mesio-angular position, according to the Winter Classification or Class II with need for ostectomy or III, with need for ostectomy and odontosection of the Prant Scale, modified by Amarillas-Escobar et al.
- That have an indication for the extraction of the lower third molars (due to recurrent infections, bad anatomical position, orthodontic indication) or a professional indication presented in writing and that are healthy (ASA I, with a negative medical history).
- Male or female gender.
- Age between 18 and 50 years.
- Good oral hygiene.
- That they agree to participate in the study, after reading and signing the Informed Consent for participation in clinical research.
Who cannot join
- Carriers of local alterations that contraindicate surgical intervention or complicate the postoperative period (example: acute phase pericoronitis in the last 30 days, ankylosis of the temporomandibular joint).
- Smokers,
- Presenting absence of upper and lower central incisors,
- With a medical history of photosensitivity
- During pregnancy or lactation,
- That they were using anti-inflammatories or analgesics,
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- Allergic to any of the drugs used in the research (amoxicillin, ketorolac, acetaminophen, dexamethasone, chlorhexidine 2%, local anesthetics, sodium bisulfite, etc.)
- That during surgery they present any type of complication (bleeding, transoperative difficulties, etc.), because these cases are not included within the expected pattern behavior for this type of surgery (these cases will be reported),
- Surgical time greater than 90 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars.The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen)These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Read the detailed description
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. To control these events, the prophylactic use of anti-inflammatory steroids has been widely recommended by some authors. However, there is no strong evidence on the real benefits of its use as opposed to its possible side effects. Photobiomodulation has proven to be a good alternative when applied in the postoperative period to control pain, edema and lockjaw. On the contrary, its application prior to a procedure of this type has not been sufficiently evaluated. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars. Healthy individuals (ASA I), who have an indication for extraction and are included in the study, will be randomly divided into two groups: Control Group: with the administration of prophylactic Corticosteroid (Dexamethasone 8 mg/ 1h before surgery), and the simulated application of Photobiomodulation, under the same protocol as the Study Group and Study Group: to which Photobiomodulation will be applied by means of intraoral Low Intensity Laser with wavelengths of 660nm and 808nm applied at 4 anatomical points (power of 0.1W, radiant exposure of 1,061 J/cm2 and energy of 3J per point and an application time of 30 seconds, totaling 12J of energy). Besides, the extraoral application will be carried out with a cluster device of combined LEDs with a total exposure area of 20cm2, which will be composed of 5 LEDs with a wavelength of 630nm (power of 0.25W per LED, a radiant exposure of 3 J /cm2 and energy of 12 J per LED spot, with an exposure time of 48 seconds) and 4 LEDs with a wavelength of 850 nm (power of 0.3W per LED, a radiant exposure of 2.4 J/cm2 and an energy of 12J per LED point, and an exposure time of 40 seconds). The Study Group will be administered a placebo tablet simulating Dexamethasone, also 1 h before the surgical procedure. The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen) after the first 3 postoperative days, where Ketorolac 10 mg will be administered orally, in a regulated manner. These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Keywords: photobiomodulation, corticosteroids, extraction, edema, pain, lockjaw, quality of life, randomized controlled trial.
- Conditions
- Molar, Third, Photobiomodulation
- Being tested
- Photobiomodulation, Placebo Corticosteroid, Simulation Photobiomodulation, Corticosteroid
- Keywords
- photobiomodulation, corticosteroids, extraction, edema, pain, mouth opening, quality of life, randomized clinical trial
- Medical subject headings
- Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Intra-oral irradiations wll be performed with a low intensity Laser device at 4 anatomical points, with a wavelength of 660 nm. The extraoral FBM will be applied with 1 cluster (20cm2) with a wavelength of 630nm. Subsequently, the same region will be irradiated with the same cluster, using the 4 LEDs with a wavelength of 850 nm 1 hour before performing the surgery.
Placebo CorticosteroidDrug
Participants will receive 1 hour before the surgery a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).).
Simulation PhotobiomodulationDevice
The irradiation simulations will be practiced in the same anatomical points described in the experimental group. This protocol will be carried out 1 hour before the surgical procedure (Baseline). The Laser device will be disconnected and its beep sound will be recorded and run on simulating the irradiation.
CorticosteroidDrug
The patients will receive Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group (n=30 surgeries) - the participants will receive the FBM, 1 hour before the surgical procedure, plus a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).). Receives: Device: Photobiomodulation; Drug: Placebo Corticosteroid |
| Control Group | Active comparator | Control group (n=30 surgeries) - patients will receive conventional treatment with Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019), plus simulation of FBM application. The Laser device will be disconnected and will be applied to the same points as in the experimental group, in the immediate pre-operative period (Baseline). Receives: Device: Simulation Photobiomodulation; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Edema baseline
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points
Measured: Edema wil be evaluated immediatly before the surgery (baseline)
Postoperative Edema - 48 hours postoperative
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Measured: Edema wil be evaluated at 2 postoperative days.
Postoperative Edema - 7day postoperative
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Measured: Edema wil be evaluated at 7 postoperative days.
Secondary outcomes (20)
Postoperative Pain baseline
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015).
A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Measured: In this study, the VAS will be used immediately before surgery (Baseline)
Postoperative Pain - 48 hours
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015).
A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Measured: In this study, the VAS will be used at 2 postoperative days
Postoperative Pain - 7 days
Pain sensitivity - The Visual Analogue Scale (VAS) is the most commonly used instrument for the assessment of postoperative pain in oral surgeries when FBM is used as post-surgical palliative therapy (Yüksek, Eroglu 2021, Momeni et al 2021, Amarillas -Escobar et al 2010, López-Ramírez et al 2011, Brignardello-Petersen et al 2012, Sierra et al 2013, Sierra et al 2015).
A rule will be used, graduated in cm, 10 cm long. One of the extremes represents "0", which means "no pain" and the other represents "10" which indicates "unbearable pain". The intermediate graduation gives patients the possibility of rating the intensity of their painful experience, from 0 to 10. This rule will be the same for all study participants and the indications for its use and marking will be given to the patient, always by the same operator
Measured: In this study, the VAS will be used 7 days before surgery
Postoperative use of analgesics - baseline
Amount of analgesics necessarily ingested, as a rescue: The amount of analgesic (Acetaminophen), a drug with a purely analgesic effect (Józwiak-Bebenista 2014) ingested by the patient (500 mg every 6 hours if the pain continues), will be recorded. At the beginning of the investigation, each patient will be given a form to record daily consumption, after the 3rd. post-operative day, and must be kept until the end of its use, at surgical discharge. At the end of the study, the amount of Acetaminophen tablets used will be evaluated as a secondary variable. The adherence of the participants to the study will be monitored through this means, asking the patients to present the form to verify its use.
Measured: The amount of analgesics will be recorded in the baseline.
Postoperative use of analgesics - 7th days
Amount of analgesics necessarily ingested, as a rescue: The amount of analgesic (Acetaminophen), a drug with a purely analgesic effect (Józwiak-Bebenista 2014) ingested by the patient (500 mg every 6 hours if the pain continues), will be recorded. At the beginning of the investigation, each patient will be given a form to record daily consumption, after the 3rd. post-operative day, and must be kept until the end of its use, at surgical discharge. At the end of the study, the amount of Acetaminophen tablets used will be evaluated as a secondary variable. The adherence of the participants to the study will be monitored through this means, asking the patients to present the form to verify its use.
Measured: The amount of analgesics will be recorded after the third postoperative day until the 7th. post-operative day.
Postoperative Trismus - baseline
Evaluation of post-operative trismus- Spasms in the masticatory muscles (lockjaw) can limit or even prevent the normal opening of the mouth after surgical removal of impacted lower third molars (Yüksek, Eroğlu, 2021, López-Ramírez et al ., 2012; Aras; Güngörmüs, 2009; Aras; Güngörmüs, 2010; Amarillas-Escobar et al., 2010; Ferrante et al., 2013). This result is generally evaluated by measuring the distance between the incisal edges of the upper and lower central incisors, using a caliper, graduated in mm (millimeters) (Yüksek, Eroğlu, 2021, Sampaio-Filho et al., 2017 , Bauer et al. 2013).
Measured: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient before the surgeries (baseline)
Postoperative Trismus 48 hours
Evaluation of post-operative trismus- Spasms in the masticatory muscles (lockjaw) can limit or even prevent the normal opening of the mouth after surgical removal of impacted lower third molars (Yüksek, Eroğlu, 2021, López-Ramírez et al ., 2012; Aras; Güngörmüs, 2009; Aras; Güngörmüs, 2010; Amarillas-Escobar et al., 2010; Ferrante et al., 2013). This result is generally evaluated by measuring the distance between the incisal edges of the upper and lower central incisors, using a caliper, graduated in mm (millimeters) (Yüksek, Eroğlu, 2021, Sampaio-Filho et al., 2017 , Bauer et al. 2013).
Measured: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient at 2 postoperative days.
Postoperative Trismus - 7 days
Evaluation of post-operative trismus- Spasms in the masticatory muscles (lockjaw) can limit or even prevent the normal opening of the mouth after surgical removal of impacted lower third molars (Yüksek, Eroğlu, 2021, López-Ramírez et al ., 2012; Aras; Güngörmüs, 2009; Aras; Güngörmüs, 2010; Amarillas-Escobar et al., 2010; Ferrante et al., 2013). This result is generally evaluated by measuring the distance between the incisal edges of the upper and lower central incisors, using a caliper, graduated in mm (millimeters) (Yüksek, Eroğlu, 2021, Sampaio-Filho et al., 2017 , Bauer et al. 2013).
Measured: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient after 7 postoperative days.
Postoperative Local temperature baseline
Local temperature -To evaluate it a thermographic photograph of the facial skin in the operated area will be taken using a FLIR C5sc 9 camera (Teledyne FLIR, Wilsonville, Oregon, USA). . The quantification of the temperature will be carried out by means of the FLIR Research IR thermal analysis software. In all photographic records, the camera-patient distance will be kept constant, as will the ambient temperature of the place where the thermographic records are made.
Measured: baseline
Postoperative Local temperature 48 hours
Local temperature -To evaluate it a thermographic photograph of the facial skin in the operated area will be taken using a FLIR C5sc 9 camera (Teledyne FLIR, Wilsonville, Oregon, USA). . The quantification of the temperature will be carried out by means of the FLIR Research IR thermal analysis software. In all photographic records, the camera-patient distance will be kept constant, as will the ambient temperature of the place where the thermographic records are made.
Measured: Thermographic photographs wil be taken 2 days after surgery.
Postoperative Local temperature - 7 days
Local temperature -To evaluate it a thermographic photograph of the facial skin in the operated area will be taken using a FLIR C5sc 9 camera (Teledyne FLIR, Wilsonville, Oregon, USA). . The quantification of the temperature will be carried out by means of the FLIR Research IR thermal analysis software. In all photographic records, the camera-patient distance will be kept constant, as will the ambient temperature of the place where the thermographic records are made.
Measured: Thermographic photographs wil be taken 7 days after surgery.
Postoperative Quality of life - baseline
Impact of the surgical procedure on the quality of life of patients - Two previously calibrated evaluators will ask patients to answer YES or NO to the following 10 questions, as described by Colorado- Bonin et al., 2006; Sato et al., 2009; savin; Grossi et al., 2007, Sierra et al. 2013, Sierra et al. 2015.
- Are you maintaining your social activities normally?
- Are you working and/or studying normally?
- Are you maintaining a normal diet?
- Do you have difficulty swallowing because of the surgery?
- Do you have difficulty perceiving the taste of food?
- Can you chew on the operated side?
- Do you have difficulty sleeping because of the surgery?
- Do you have difficulty speaking because of the surgery?
- Has your physical appearance changed because of the surgery?
- Are you angry about the surgery?
Measured: Quality of life will be evaluated in the baseline
Postoperative Quality of life - 48 hours
Impact of the surgical procedure on the quality of life of patients - Two previously calibrated evaluators will ask patients to answer YES or NO to the following 10 questions, as described by Colorado- Bonin et al., 2006; Sato et al., 2009; savin; Grossi et al., 2007, Sierra et al. 2013, Sierra et al. 2015.
- Are you maintaining your social activities normally?
- Are you working and/or studying normally?
- Are you maintaining a normal diet?
- Do you have difficulty swallowing because of the surgery?
- Do you have difficulty perceiving the taste of food?
- Can you chew on the operated side?
- Do you have difficulty sleeping because of the surgery?
- Do you have difficulty speaking because of the surgery?
- Has your physical appearance changed because of the surgery?
- Are you angry about the surgery?
Measured: Quality of life will be evaluated two days after surgery,
Postoperative Quality of life - 7 days
Impact of the surgical procedure on the quality of life of patients - Two previously calibrated evaluators will ask patients to answer YES or NO to the following 10 questions, as described by Colorado- Bonin et al., 2006; Sato et al., 2009; savin; Grossi et al., 2007, Sierra et al. 2013, Sierra et al. 2015.
- Are you maintaining your social activities normally?
- Are you working and/or studying normally?
- Are you maintaining a normal diet?
- Do you have difficulty swallowing because of the surgery?
- Do you have difficulty perceiving the taste of food?
- Can you chew on the operated side?
- Do you have difficulty sleeping because of the surgery?
- Do you have difficulty speaking because of the surgery?
- Has your physical appearance changed because of the surgery?
- Are you angry about the surgery?
Measured: Quality of life will be evaluated seven days after surgery,
Postoperative Dysphagia baseline
Dysphagia - The evaluation of dysphagia will be carried out through a questionnaire (Sampaio-Filho et al., 2017) that will classify on a numerical scale as follows:
(0)= total absence of dysphagia.
- = dysphagia to solid foods.
- = dysphagia to any food, liquid or solid.
Measured: Dysphagia will be evaluated at baseline
Postoperative Dysphagia 48 hours
Dysphagia - The evaluation of dysphagia will be carried out through a questionnaire (Sampaio-Filho et al., 2017) that will classify on a numerical scale as follows:
(0)= total absence of dysphagia.
- = dysphagia to solid foods.
- = dysphagia to any food, liquid or solid.
Measured: Dysphagia will be evaluated at 2 days post-surgery
Postoperative Dysphagia - 7 days
Dysphagia - The evaluation of dysphagia will be carried out through a questionnaire (Sampaio-Filho et al., 2017) that will classify on a numerical scale as follows:
(0)= total absence of dysphagia.
- = dysphagia to solid foods.
- = dysphagia to any food, liquid or solid.
Measured: Dysphagia will be evaluated 7 days post-surgery
Postoperative Hematoma/ecchymosis - baseline
The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes in the skin of the jugal and submandibular region with a millimetric graduated malleable rule. The measurement will be carried out by the previously calibrated evaluator, who will classify the appearance of this finding into 4 categories:
- non-existent;
- the largest diameter is less than 4 cm;
- the largest diameter is between 4 and 10 cm;
- the largest diameter is greater than 10 cm; as described by Bjornsson et al., (2003).
Measured: Hematoma/ecchymosis will be evaluated at baseline
Postoperative Hematoma/ecchymosis
The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes in the skin of the jugal and submandibular region with a millimetric graduated malleable rule. The measurement will be carried out by the previously calibrated evaluator, who will classify the appearance of this finding into 4 categories:
- non-existent;
- the largest diameter is less than 4 cm;
- the largest diameter is between 4 and 10 cm;
- the largest diameter is greater than 10 cm; as described by Bjornsson et al., (2003).
Measured: Hematoma/ecchymosis will be evaluated 2 days after surgery,
Postoperative Hematoma/ecchymosis - 7 days
The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes in the skin of the jugal and submandibular region with a millimetric graduated malleable rule. The measurement will be carried out by the previously calibrated evaluator, who will classify the appearance of this finding into 4 categories:
- non-existent;
- the largest diameter is less than 4 cm;
- the largest diameter is between 4 and 10 cm;
- the largest diameter is greater than 10 cm; as described by Bjornsson et al., (2003).
Measured: Hematoma/ecchymosis will be evaluated 7 days after surgery,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start20 Nov 2023
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924191
- Sponsor's protocol ID
- CIRUCU
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05924191
- Acronym / sponsor ID
- CIRUCU
- Conditions
- Molar, Third, Photobiomodulation
- Keywords
- photobiomodulation, corticosteroids, extraction, edema, pain, mouth opening, quality of life, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 29 Jun 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.
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars.The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen)These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Detailed description
Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. To control these events, the prophylactic use of anti-inflammatory steroids has been widely recommended by some authors. However, there is no strong evidence on the real benefits of its use as opposed to its possible side effects. Photobiomodulation has proven to be a good alternative when applied in the postoperative period to control pain, edema and lockjaw. On the contrary, its application prior to a procedure of this type has not been sufficiently evaluated. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars. Healthy individuals (ASA I), who have an indication for extraction and are included in the study, will be randomly divided into two groups: Control Group: with the administration of prophylactic Corticosteroid (Dexamethasone 8 mg/ 1h before surgery), and the simulated application of Photobiomodulation, under the same protocol as the Study Group and Study Group: to which Photobiomodulation will be applied by means of intraoral Low Intensity Laser with wavelengths of 660nm and 808nm applied at 4 anatomical points (power of 0.1W, radiant exposure of 1,061 J/cm2 and energy of 3J per point and an application time of 30 seconds, totaling 12J of energy). Besides, the extraoral application will be carried out with a cluster device of combined LEDs with a total exposure area of 20cm2, which will be composed of 5 LEDs with a wavelength of 630nm (power of 0.25W per LED, a radiant exposure of 3 J /cm2 and energy of 12 J per LED spot, with an exposure time of 48 seconds) and 4 LEDs with a wavelength of 850 nm (power of 0.3W per LED, a radiant exposure of 2.4 J/cm2 and an energy of 12J per LED point, and an exposure time of 40 seconds). The Study Group will be administered a placebo tablet simulating Dexamethasone, also 1 h before the surgical procedure. The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen) after the first 3 postoperative days, where Ketorolac 10 mg will be administered orally, in a regulated manner. These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.
Keywords: photobiomodulation, corticosteroids, extraction, edema, pain, lockjaw, quality of life, randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Photobiomodulation, Drug: Placebo CorticosteroidExperimental group (n=30 surgeries) - the participants will receive the FBM, 1 hour before the surgical procedure, plus a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).). |
| Control Group | Active comparator | Device: Simulation Photobiomodulation, Drug: CorticosteroidControl group (n=30 surgeries) - patients will receive conventional treatment with Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019), plus simulation of FBM application. The Laser device will be disconnected and will be applied to the same points as in the experimental group, in the immediate pre-operative period (Baseline). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who present retained lower third molars, according to the degree of surgical difficulty of the procedure and the anatomical position.The selected molars will be those classified according to classes II and III and/or B or C of Pell and Gregory Classification; in vertical or mesio-angular position, according to the Winter Classification or Class II with need for ostectomy or III, with need for ostectomy and odontosection of the Prant Scale, modified by Amarillas-Escobar et al.
- That have an indication for the extraction of the lower third molars (due to recurrent infections, bad anatomical position, orthodontic indication) or a professional indication presented in writing and that are healthy (ASA I, with a negative medical history).
- Male or female gender.
- Age between 18 and 50 years.
- Good oral hygiene.
Key exclusion criteria (9 listed)
- Carriers of local alterations that contraindicate surgical intervention or complicate the postoperative period (example: acute phase pericoronitis in the last 30 days, ankylosis of the temporomandibular joint).
- Smokers,
- Presenting absence of upper and lower central incisors,
- With a medical history of photosensitivity
- During pregnancy or lactation,
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 |
|---|---|---|
| PhotobiomodulationIntra-oral irradiations wll be performed with a low intensity Laser device at 4 anatomical points, with a wavelength of 660 nm. The extraoral FBM will be applied with 1 cluster (20cm2) with a wavelength of 630nm. Subsequently, the same region will be irradiated with the same cluster, using the 4 LEDs with a wavelength of 850 nm 1 hour before performing the surgery. | Device | Experimental Group |
| Placebo CorticosteroidParticipants will receive 1 hour before the surgery a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).). | Drug | Experimental Group |
| Simulation PhotobiomodulationThe irradiation simulations will be practiced in the same anatomical points described in the experimental group. This protocol will be carried out 1 hour before the surgical procedure (Baseline). The Laser device will be disconnected and its beep sound will be recorded and run on simulating the irradiation. | Device | Control Group |
| CorticosteroidThe patients will receive Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019) | Drug | Control Group |
Primary outcome
Postoperative Edema baseline
Time frame: Edema wil be evaluated immediatly before the surgery (baseline)
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points
Postoperative Edema - 48 hours postoperative
Time frame: Edema wil be evaluated at 2 postoperative days.
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
Postoperative Edema - 7day postoperative
Time frame: Edema wil be evaluated at 7 postoperative days.
To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.
20 secondary outcomes
Postoperative Pain baseline
Time frame: In this study, the VAS will be used immediately before surgery (Baseline)
Postoperative Pain - 48 hours
Time frame: In this study, the VAS will be used at 2 postoperative days
Postoperative Pain - 7 days
Time frame: In this study, the VAS will be used 7 days before surgery
Postoperative use of analgesics - baseline
Time frame: The amount of analgesics will be recorded in the baseline.
Postoperative use of analgesics - 7th days
Time frame: The amount of analgesics will be recorded after the third postoperative day until the 7th. post-operative day.
Postoperative Trismus - baseline
Time frame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient before the surgeries (baseline)
Postoperative Trismus 48 hours
Time frame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient at 2 postoperative days.
Postoperative Trismus - 7 days
Time frame: In the present study, the previously calibrated evaluators will measure the mouth opening in each patient after 7 postoperative days.
Postoperative Local temperature baseline
Time frame: baseline
Postoperative Local temperature 48 hours
Time frame: Thermographic photographs wil be taken 2 days after surgery.
Postoperative Local temperature - 7 days
Time frame: Thermographic photographs wil be taken 7 days after surgery.
Postoperative Quality of life - baseline
Time frame: Quality of life will be evaluated in the baseline
Postoperative Quality of life - 48 hours
Time frame: Quality of life will be evaluated two days after surgery,
Postoperative Quality of life - 7 days
Time frame: Quality of life will be evaluated seven days after surgery,
Postoperative Dysphagia baseline
Time frame: Dysphagia will be evaluated at baseline
Postoperative Dysphagia 48 hours
Time frame: Dysphagia will be evaluated at 2 days post-surgery
Postoperative Dysphagia - 7 days
Time frame: Dysphagia will be evaluated 7 days post-surgery
Postoperative Hematoma/ecchymosis - baseline
Time frame: Hematoma/ecchymosis will be evaluated at baseline
Postoperative Hematoma/ecchymosis
Time frame: Hematoma/ecchymosis will be evaluated 2 days after surgery,
Postoperative Hematoma/ecchymosis - 7 days
Time frame: Hematoma/ecchymosis will be evaluated 7 days after surgery,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation, Simulation Photobiomodulation and Corticosteroid in people with Molar, Third and Photobiomodulation, run by University of Nove de Julho at 1 site in Brazil.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jul 2026. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Edema baseline (time frame: Edema wil be evaluated immediatly before the surgery (baseline)). The study lists 3 primary outcomes in all. 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 29 Jul 2026.