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

NCT05935306 | Recruiting

• 1 other identifier: Pain after endodontic surgery
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Photobiomodulation; Endodontic Disease; Pain; Inflammation; Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours after treatment

Secondary Outcomes (22)

• Pain in postoperative period - 7 days after treatment

  7th days after treatment

• Quantity of analgesics taken in the specific periods - baseline

  Baseline (Before the intervention)

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

  24 hours after treatment

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

  7 days after treatment

• Edema - baseline

  Baseline (Before the intervention)

Study Arms (2)

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.

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.

Device: Photobiomodulation; Other: Ibuprofen simulation

Interventions

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.

Also known as: antinflamatory

G1- Control group

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.

G1- Control group

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.

G2- Intervention group

Ibuprofen simulation OTHER

Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)

Also known as: antinflamatory placebo

G2- Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• :• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Catolica do Uruguay

Montevideo, Uruguay

RECRUITING

Related Publications (1)

• 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.

  PMID: 41218940 DERIVED

MeSH Terms

Conditions

Dental Pulp Diseases; Pain; Inflammation

Interventions

Ibuprofen; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Rolf Wilhem C Cirisola

CONTACT

13981999848; drconsolandich@gmail.com

Anna CR Horliana

CONTACT

13981999848; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.. Immediately after finishing the suture, the investigator in charge of applying the FBM will remove and open 1 envelope (without changing the numerical sequence of the other envelopes) and perform the indicated procedure or its simulation. Only this researcher will know the nature of the treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 7, 2023
• Study Start: June 30, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available upon reasonable request after the completion of the study, expected in December 2025, and will remain available for at least five years.
• Access Criteria: Access to the data will be granted upon reasonable request to the corresponding author. There will be no restrictions on access, provided that the data are appropriately cited and used in accordance with ethical guidelines.

Locations

UR (1)