PhotobiomodulationNCT05935306
Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
A study testing Ibuprofen, Photobiomodulation simulation and Photobiomodulation in people with Photobiomodulation and Endodontic Disease, run by University of Nove de Julho at 1 site in Uruguay.
Trial summary
The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Photobiomodulation, Endodontic Disease, Pain
- What is being tested?
- Ibuprofen, Photobiomodulation simulation and Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUruguay
- Study dates
- 30 Jun 2024to 1 Dec 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- :• Patients with periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions)
- Patients with not comorbidities,
- Age from 18 to 70 years,
- Both genders,
- Healthy permanent teeth with good hygiene.
Who cannot join
- Who are taking drugs that affect bone metabolism and the inflammatory process (for example: corticosteroids, bisphosphonates),
- Smokers, pregnant or lactating women,
- Who used anti-inflammatory drugs in the last 3 months before surgery.
- Who for any reason interrupted the evolution of the treatment for not attending joint appointments.
- Patients who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial
The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) a FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator).. Radiographic images will be obtained after 1 and 2 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.
Read the detailed description
Photobiomodulation (FBM) has shown favorable results in the postoperative period of endodontic surgery, however, up to now, the level of evidence in this procedure is low. The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled, and double-blind clinical study, 34 Uruguayan participants of both sexes who previously consulted at the Clínica Universitaria de la Salud, with a diagnosis of periodontitis with an apical lesion less than 10mm with or without a fistula, diagnosed clinically and radiographically, in the upper maxillary region (from 15 to 25) will be recruited. Participants included in the study must have periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions), no comorbidities, age from 18 to 70 years, both genders, healthy permanent teeth with good hygiene. Participants will be excluded if they are taking drugs that affect bone metabolism and the inflammatory process (for example corticosteroids, bisphosphonates), Smokers, pregnant or lactating women, if used anti-inflammatory drugs in the last 3 months before surgery, who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate). They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours, and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator). Radiographic images will be obtained after 1 and 3 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, the temperature with a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd months, respectively. Once all the data have been collected, their normality will be tested, and the one-way ANOVA test and the complementary Tukey test will be carried out. Data will be presented as mean ± standard deviation (SD) and the accepted p-value will be <0.0
- Conditions
- Photobiomodulation, Endodontic Disease, Pain, Inflammation, Surgery
- Being tested
- Ibuprofen, Photobiomodulation simulation, Photobiomodulation, Ibuprofen simulation
- Medical subject headings
- Dental Pulp Diseases, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called antinflamatory
All participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group.
Photobiomodulation simulationOther
The person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off.
PhotobiomodulationDevice
. Patients will receive FBM and will be treated identically to the G2 group. The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away.
Ibuprofen simulationOther
Also called antinflamatory placebo
Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)
| Study group | Role | What they receive |
|---|---|---|
| G1- Control group | Active comparator | Conventional treatment + FBM simulation (n = 17 patients): All participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group. The person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off. Thus for the participant does not identify the group to which he belongs, the device activation sound (beep) will be recorded and it will turn on at the time of application. Receives: Drug: Ibuprofen; Other: Photobiomodulation simulation |
| G2- Intervention group | Experimental | Conventional treatment with placebo ibuprofen + FBM (n = 17) All participants will undergo the same surgical procedure. Patients will receive FBM (Table 1) and will be treated identically to the G2 group.
The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away. A dot will be irradiated in the middle of the square (Figure 1). Placebo ibuprofen will be manipulated. Receives: Device: Photobiomodulation; Other: Ibuprofen simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in postoperative period - baseline
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
Measured: Baseline (Before the intervention)
Pain in postoperative period - 24 hours after treatment
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
Measured: 24 hours after treatment
Secondary outcomes (22)
Pain in postoperative period - 7 days after treatment
Pain will also be assessed on the 7th day after surgery; however, this is defined as a secondary outcome, since other postoperative parameters-such as edema, ecchymosis, and soft tissue condition-will be evaluated at this time. Based on the literature, we do not expect significant pain at this later stage
Measured: 7th days after treatment
Quantity of analgesics taken in the specific periods - baseline
The number of analgesics taken at the baseline will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for use solely in cases of pain after surgery.
Measured: Baseline (Before the intervention)
Quantity of analgesics taken in the specific periods - 24 hours after treatment
The number of analgesics taken in the first 24 hours following surgery will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for usage solely in cases of pain.
Measured: 24 hours after treatment
Quantity of analgesics taken in the specific periods - 7 days after treatment
The number of analgesics taken in the seven days following surgery will be recorded. Paracetamol will be the sole analgesic administered to the patients and recommended for usage solely in cases of pain.
Measured: 7 days after treatment
Edema - baseline
A scale will be used to quantify the extent of edema. This scale has scores ranging from 0 to 3: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, and 3 = diffuse edema. This outcome will be measured at baseline, 24 hours, and seven days after surgery.
Measured: Baseline (Before the intervention)
Edema - 24 hours after treatment
A scale will be used to quantify the extent of edema. This scale has scores ranging from 0 to 3: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, and 3 = diffuse edema. This outcome will be measured at baseline, 24 hours, and seven days after surgery.
Measured: 24 hours after treatment
Edema - 7 days after treatment
A scale will be used to quantify the extent of edema. This scale has scores ranging from 0 to 3: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, and 3 = diffuse edema. This outcome will be measured at baseline, 24 hours, and seven days after surgery.
Measured: 7 days after treatment
Ecchymosis - baseline
Ecchymosis refers to bleeding in the subcutaneous tissue caused by the rupture of one or more capillaries, often resulting from surgical trauma and characterized by a diameter greater than 1 cm. The assessment scale for ecchymosis is defined as follows: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot between 4 and 10 cm in diameter, 3 = spot larger than 10 cm in diameter.
Measured: Baseline (Before the intervention)
Ecchymosis - 24 hours after treatment
Ecchymosis refers to bleeding in the subcutaneous tissue caused by the rupture of one or more capillaries, often resulting from surgical trauma and characterized by a diameter greater than 1 cm. The assessment scale for ecchymosis is defined as follows: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot between 4 and 10 cm in diameter, 3 = spot larger than 10 cm in diameter.
Measured: 24 hours after treatment
Ecchymosis -7 days after treatment
Ecchymosis refers to bleeding in the subcutaneous tissue caused by the rupture of one or more capillaries, often resulting from surgical trauma and characterized by a diameter greater than 1 cm. The assessment scale for ecchymosis is defined as follows: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot between 4 and 10 cm in diameter, 3 = spot larger than 10 cm in diameter.
Measured: 7 days after treatment
Soft tissue healing - baseline
Score 1: No opening along the incision line, no drainage (pus or exudate), no inflammation, and no pain. Score 2: No opening along the incision line, no drainage, mild swelling, and mild pain. Score 3: No opening along the incision line, active drainage, advanced inflammation, and moderate to severe pain. Score 4: Opening along the incision line, active drainage, advanced inflammation, and persistent pain.
Measured: Baseline (Before the intervention)
Soft tissue healing - 24 hours after treatment
Score 1: No opening along the incision line, no drainage (pus or exudate), no inflammation, and no pain. Score 2: No opening along the incision line, no drainage, mild swelling, and mild pain. Score 3: No opening along the incision line, active drainage, advanced inflammation, and moderate to severe pain. Score 4: Opening along the incision line, active drainage, advanced inflammation, and persistent pain.
Measured: 24 hours after treatment
Soft tissue healing -7 days after treatment
Score 1: No opening along the incision line, no drainage (pus or exudate), no inflammation, and no pain. Score 2: No opening along the incision line, no drainage, mild swelling, and mild pain. Score 3: No opening along the incision line, active drainage, advanced inflammation, and moderate to severe pain. Score 4: Opening along the incision line, active drainage, advanced inflammation, and persistent pain.
Measured: 7 days after treatment
Bone consolidation - baseline
Bone consolidation will be assessed using periapical radiography to investigate two-dimensional changes in the bone defects. Consistent with the same equipment and employing the parallelism technique, periapical radiographs will be taken in the immediate preoperative period for comparative analysis with those taken at one and three months. The area of the defect will be determined by multiplying the longest mesiodistal and superoinferior diameters visible on the radiographs. On all radiographs, the longest diameter of the lesion will be measured. The periapical index will be determined, with the following interpretation: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5 to 1 mm, 2 = periapical radiolucency with a diameter of 1.1 to 2 mm, 3 = periapical radiolucency with a diameter of 2.1 to 4 mm, 4 = periapical radiolucency with a diameter of 4.1 to 8 mm, and 5 = periapical radiolucency greater than 8.1 mm in diameter.
Measured: Baseline (Before the intervention)
Bone consolidation - 1 month
Bone consolidation will be assessed using periapical radiography to investigate two-dimensional changes in the bone defects. Consistent with the same equipment and employing the parallelism technique, periapical radiographs will be taken in the immediate preoperative period for comparative analysis with those taken at one and three months. The area of the defect will be determined by multiplying the longest mesiodistal and superoinferior diameters visible on the radiographs. On all radiographs, the longest diameter of the lesion will be measured. The periapical index will be determined, with the following interpretation: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5 to 1 mm, 2 = periapical radiolucency with a diameter of 1.1 to 2 mm, 3 = periapical radiolucency with a diameter of 2.1 to 4 mm, 4 = periapical radiolucency with a diameter of 4.1 to 8 mm, and 5 = periapical radiolucency greater than 8.1 mm in diameter.
Measured: 1 month
Bone consolidation - 3 months
Bone consolidation will be assessed using periapical radiography to investigate two-dimensional changes in the bone defects. Consistent with the same equipment and employing the parallelism technique, periapical radiographs will be taken in the immediate preoperative period for comparative analysis with those taken at one and three months. The area of the defect will be determined by multiplying the longest mesiodistal and superoinferior diameters visible on the radiographs. On all radiographs, the longest diameter of the lesion will be measured. The periapical index will be determined, with the following interpretation: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5 to 1 mm, 2 = periapical radiolucency with a diameter of 1.1 to 2 mm, 3 = periapical radiolucency with a diameter of 2.1 to 4 mm, 4 = periapical radiolucency with a diameter of 4.1 to 8 mm, and 5 = periapical radiolucency greater than 8.1 mm in diameter.
Measured: 3 months
Local temperature - baseline
Temperature will be measured in degrees Celsius and compared to the baseline temperature
Measured: Baseline (Before the intervention)
Local temperature - 24 hours after treatment
Temperature will be measured in degrees Celsius and compared to the baseline temperature
Measured: 24 hours after treatment
Local temperature - 7 days after treatment
Temperature will be measured in degrees Celsius and compared to the baseline temperature
Measured: 7 days after treatment
Sistemic temperature - baseline
Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela
Measured: Baseline (Before the intervention)
Sistemic temperature - 24 hours after treatment
Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela
Measured: 24 hours after treatment
Sistemic temperature - 7 days after treatment
Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela
Measured: 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Jun 2024
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhotobiomodulationStudies 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
- Model description
- This randomized, controlled, double-blind superiority clinical trial meets the criteria for designing a clinical trial in accordance with the SPIRIT Statement. It was accepted by Research Ethics Committee (CEP) of the Catholic University of Uruguay
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT05935306
- Sponsor's protocol ID
- Pain after endodontic surgery
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request
Publications
Cirisola RWC, Moya LEP, Olazabal MVG, Wagmann DAA, Suarez GP, Wince C, Bruno MLH, Salaberry DR, Sobral APT, Longo PL, Motta LJ, Bussadori SK, Duran CCG, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol. BMJ Open. 2025 Nov 11;15(11):e089986. doi: 10.1136/bmjopen-2024-089986.
PubMed 41218940
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
- Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05935306
- Acronym / sponsor ID
- Pain after endodontic surgery
- Conditions
- Photobiomodulation, Endodontic Disease, Pain, Inflammation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 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.
The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) a FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator).. Radiographic images will be obtained after 1 and 2 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.
Detailed description
Photobiomodulation (FBM) has shown favorable results in the postoperative period of endodontic surgery, however, up to now, the level of evidence in this procedure is low. The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled, and double-blind clinical study, 34 Uruguayan participants of both sexes who previously consulted at the Clínica Universitaria de la Salud, with a diagnosis of periodontitis with an apical lesion less than 10mm with or without a fistula, diagnosed clinically and radiographically, in the upper maxillary region (from 15 to 25) will be recruited. Participants included in the study must have periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions), no comorbidities, age from 18 to 70 years, both genders, healthy permanent teeth with good hygiene. Participants will be excluded if they are taking drugs that affect bone metabolism and the inflammatory process (for example corticosteroids, bisphosphonates), Smokers, pregnant or lactating women, if used anti-inflammatory drugs in the last 3 months before surgery, who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate). They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours, and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator). Radiographic images will be obtained after 1 and 3 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, the temperature with a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd months, respectively. Once all the data have been collected, their normality will be tested, and the one-way ANOVA test and the complementary Tukey test will be carried out. Data will be presented as mean ± standard deviation (SD) and the accepted p-value will be <0.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, controlled, double-blind superiority clinical trial meets the criteria for designing a clinical trial in accordance with the SPIRIT Statement. It was accepted by Research Ethics Committee (CEP) of the Catholic University of Uruguay
| Arm | Type | Receives |
|---|---|---|
| G1- Control group | Active comparator | Drug: Ibuprofen, Other: Photobiomodulation simulationConventional treatment + FBM simulation (n = 17 patients): All participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group. The person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off. Thus for the participant does not identify the group to which he belongs, the device activation sound (beep) will be recorded and it will turn on at the time of application. |
| G2- Intervention group | Experimental | Device: Photobiomodulation, Other: Ibuprofen simulationConventional treatment with placebo ibuprofen + FBM (n = 17) All participants will undergo the same surgical procedure. Patients will receive FBM (Table 1) and will be treated identically to the G2 group. The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away. A dot will be irradiated in the middle of the square (Figure 1). Placebo ibuprofen will be manipulated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- :• Patients with periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions)
- Patients with not comorbidities,
- Age from 18 to 70 years,
- Both genders,
- Healthy permanent teeth with good hygiene.
Key exclusion criteria (5 listed)
- Who are taking drugs that affect bone metabolism and the inflammatory process (for example: corticosteroids, bisphosphonates),
- Smokers, pregnant or lactating women,
- Who used anti-inflammatory drugs in the last 3 months before surgery.
- Who for any reason interrupted the evolution of the treatment for not attending joint appointments.
- Patients who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate)
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 |
|---|---|---|
| IbuprofenAlso: antinflamatoryAll participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group. | Drug | G1- Control group |
| Photobiomodulation simulationThe person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off. | Other | G1- Control group |
| Photobiomodulation. Patients will receive FBM and will be treated identically to the G2 group. The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away. | Device | G2- Intervention group |
| Ibuprofen simulationAlso: antinflamatory placeboPlacebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez) | Other | G2- Intervention group |
Primary outcome
Pain in postoperative period - baseline
Time frame: Baseline (Before the intervention)
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
Pain in postoperative period - 24 hours after treatment
Time frame: 24 hours after treatment
The primary outcome was Pain in the postoperative period, assessed using a 10 cm Visual Analogue Scale (VAS), where 0 represented "no pain" and 10 represented "worst pain imaginable." The main analysis focused on the change in pain intensity at 24 hours postoperatively compared to baseline (immediate postoperative period), as this time point is considered the most clinically relevant for evaluating the effectiveness of photobiomodulation in the management of acute postoperative pain.
22 secondary outcomes
Pain in postoperative period - 7 days after treatment
Time frame: 7th days after treatment
Quantity of analgesics taken in the specific periods - baseline
Time frame: Baseline (Before the intervention)
Quantity of analgesics taken in the specific periods - 24 hours after treatment
Time frame: 24 hours after treatment
Quantity of analgesics taken in the specific periods - 7 days after treatment
Time frame: 7 days after treatment
Edema - baseline
Time frame: Baseline (Before the intervention)
Edema - 24 hours after treatment
Time frame: 24 hours after treatment
Edema - 7 days after treatment
Time frame: 7 days after treatment
Ecchymosis - baseline
Time frame: Baseline (Before the intervention)
Ecchymosis - 24 hours after treatment
Time frame: 24 hours after treatment
Ecchymosis -7 days after treatment
Time frame: 7 days after treatment
Soft tissue healing - baseline
Time frame: Baseline (Before the intervention)
Soft tissue healing - 24 hours after treatment
Time frame: 24 hours after treatment
Soft tissue healing -7 days after treatment
Time frame: 7 days after treatment
Bone consolidation - baseline
Time frame: Baseline (Before the intervention)
Bone consolidation - 1 month
Time frame: 1 month
Bone consolidation - 3 months
Time frame: 3 months
Local temperature - baseline
Time frame: Baseline (Before the intervention)
Local temperature - 24 hours after treatment
Time frame: 24 hours after treatment
Local temperature - 7 days after treatment
Time frame: 7 days after treatment
Sistemic temperature - baseline
Time frame: Baseline (Before the intervention)
Sistemic temperature - 24 hours after treatment
Time frame: 24 hours after treatment
Sistemic temperature - 7 days after treatment
Time frame: 7 days after treatment
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.
- Derived from this study: PubMed 41218940Cirisola RWC, Moya LEP, Olazabal MVG, Wagmann DAA, Suarez GP, Wince C, Bruno MLH, Salaberry DR, Sobral APT, Longo PL, Motta LJ, Bussadori SK, Duran CCG, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol. BMJ Open. 2025 Nov 11;15(11):e089986. doi: 10.1136/bmjopen-2024-089986.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request
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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 Ibuprofen, Photobiomodulation simulation and Photobiomodulation in people with Photobiomodulation and Endodontic Disease, run by University of Nove de Julho at 1 site in Uruguay.
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 5 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: 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 Uruguay. 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?
Pain in postoperative period - baseline (time frame: Baseline (Before the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935306, which also lists 1 linked publication.
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.