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NCT Number: NCT05935306

Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery

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.

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Key information

Conditions

Photobiomodulation Dental Pulp Diseases Endodontic Disease Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Surgery Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Catolica do Uruguay

Montevideo, Uruguay

Location status: Recruiting

Location contact

Rolf Wilhem C Cirisola, PhD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

:• 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.

Exclusion criteria

  • 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)

Treatment and study plan

Ibuprofen

Drug

All participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group.

Other names: antinflamatory

Photobiomodulation simulation

Other

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.

Photobiomodulation

Device

. 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 simulation

Other

Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)

Other names: antinflamatory placebo

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain in postoperative period - 7 days after treatment

    Time frame: 7th 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

  2. Quantity of analgesics taken in the specific periods - baseline

    Time frame: Baseline (Before the intervention)

    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.

  3. Quantity of analgesics taken in the specific periods - 24 hours after treatment

    Time frame: 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.

  4. Quantity of analgesics taken in the specific periods - 7 days after treatment

    Time frame: 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.

  5. Edema - baseline

    Time frame: Baseline (Before the intervention)

    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.

  6. Edema - 24 hours after treatment

    Time frame: 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.

  7. Edema - 7 days after treatment

    Time frame: 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.

  8. Ecchymosis - baseline

    Time frame: Baseline (Before the intervention)

    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.

  9. Ecchymosis - 24 hours after treatment

    Time frame: 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.

  10. Ecchymosis -7 days after treatment

    Time frame: 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.

  11. Soft tissue healing - baseline

    Time frame: Baseline (Before the intervention)

    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.

  12. Soft tissue healing - 24 hours after treatment

    Time frame: 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.

  13. Soft tissue healing -7 days after treatment

    Time frame: 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.

  14. Bone consolidation - baseline

    Time frame: Baseline (Before the intervention)

    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.

  15. Bone consolidation - 1 month

    Time frame: 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.

  16. Bone consolidation - 3 months

    Time frame: 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.

  17. Local temperature - baseline

    Time frame: Baseline (Before the intervention)

    Temperature will be measured in degrees Celsius and compared to the baseline temperature

  18. Local temperature - 24 hours after treatment

    Time frame: 24 hours after treatment

    Temperature will be measured in degrees Celsius and compared to the baseline temperature

  19. Local temperature - 7 days after treatment

    Time frame: 7 days after treatment

    Temperature will be measured in degrees Celsius and compared to the baseline temperature

  20. Sistemic temperature - baseline

    Time frame: Baseline (Before the intervention)

    Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela

  21. Sistemic temperature - 24 hours after treatment

    Time frame: 24 hours after treatment

    Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela

  22. Sistemic temperature - 7 days after treatment

    Time frame: 7 days after treatment

    Temperature will be measured in degrees Celsius and compared to the baseline temperature in the glabela

Study contacts

Contact information is provided by the study sponsor or research team.

Anna CR Horliana

CONTACT

[email protected]

13981999848

Rolf Wilhem C Cirisola

CONTACT

[email protected]

13981999848

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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