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

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935306

Collaborator

(none)

Enrollment

Arms

16.1

Anticipated Duration (Months)

Study Details

Study Description

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 analogue 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 implement. 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 thermographic camera and a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The impact of the surgery on the patient's quality of life will be evaluated by applying the OHIP 14 questionnaire. The OHIP will be applied on the 7th day of the intervention and the X-rays will be taken in the 1st and 3rd month respectively.

Condition or Disease	Intervention/Treatment	Phase
Photobiomodulation Endodontic Disease Pain Inflammation Surgery	Drug: Ibuprofen Other: FBM simulation Device: FBM Other: Ibuprofen simulation	N/A

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 implement. 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 thermographic camera and a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The impact of the surgery on the patient's quality of life will be evaluated by applying the OHIP 14 questionnaire. The OHIP will be applied on the intervention's 7th day, and 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

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 UruguayThis 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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: G1- Control group 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 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: FBM simulation 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.
Experimental: G2- Intervention group 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: FBM . 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. Other: Ibuprofen simulation Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)

Arm

Intervention/Treatment

Active Comparator: G1- Control group

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

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: FBM simulation

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.

Experimental: G2- Intervention group

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: FBM

. 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.

Other: Ibuprofen simulation

Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)

Outcome Measures

Primary Outcome Measures

Pain in postoperative period - baseline [at baseline]
Pain will be measured during the immediate postoperative period of endodontic surgery using the Visual Analogue Scale (VAS) measured in millimeters, where "0" is no pain and "10" is the worst pain in life (Metin et al. ., 2018, Sampaio-Filho et al., 2018).
Pain in postoperative period - 24 hours after treatment [24 hours after treatment]
Pain will be measured at 24hours of postoperative period of endodontic surgery using the Visual Analogue Scale (VAS) measured in millimeters, where "0" is no pain and "10" is the worst pain in life (Metin et al. ., 2018, Sampaio-Filho et al., 2018).
Pain in postoperative period -7 days after treatment [7 days after treatment]
Pain will be measured at 7d of postoperative period of endodontic surgery using the Visual Analogue Scale (VAS) measured in millimeters, where "0" is no pain and "10" is the worst pain in life (Metin et al., 2018, Sampaio-Filho et al., 2018).

Secondary Outcome Measures

Quantity of painkillers ingested in the period - baseline [at baseline]
the number of painkillers ingested will be counted. The analgesic used will be only paracetamol that will be administered to the patient, but it is advisable to take it only in case of pain (Sampaio-Filho et al., 2018). A procedure will be carried out to monitor the adherence of the participants (for example, each patient will be asked to bring the pain reliever pack to the appointment to see how it is used).
Quantity of painkillers ingested in the period - 24 hours after treatment [24 hours after treatment]
the quantity of painkillers ingested in the 24-hours will be counted. The analgesic used will be only paracetamol that will be administered to the patient, but it is advisable to take it only in case of pain (Sampaio-Filho et al., 2018). A procedure will be carried out to monitor the adherence of the participants (for example, each patient will be asked to bring the pain reliever pack to the appointment to see how it is used).
Quantity of painkillers ingested in the period - 7 days after treatment [7 days after treatment]
the number of painkillers ingested in the 7-day period will be counted. The analgesic used will be only paracetamol that will be administered to the patient, but it is advisable to take it only in case of pain (Sampaio-Filho et al., 2018). A procedure will be carried out to monitor the adherence of the participants (for example, each patient will be asked to bring the pain reliever pack to the appointment to see how it is used).
Edema - baseline [at baseline]
A scale will be used to quantify the amount of edema as recommended by some authors (Metin et al., 2018). The scale is made up of scores from 0 to 3, where: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, 3 = diffuse edema (Metin et al., 2018).
Edema - 24 hours after treatment [24 hours after treatment]
A scale will be used to quantify the amount of edema as recommended by some authors (Metin et al., 2018). The scale is made up of scores from 0 to 3, where: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, 3 = diffuse edema (Metin et al., 2018).
Edema - 7 days after treatment [7 days after treatment]
A scale will be used to quantify the amount of edema as recommended by some authors (Metin et al., 2018). The scale is made up of scores from 0 to 3, where: 0 = no edema, 1 = intraoral edema, 2 = extraoral edema, 3 = diffuse edema (Metin et al., 2018).
Ecchymosis - baseline [at baseline]
is bleeding in the subcutaneous tissue, with a diameter greater than 1 cm, which is caused by the rupture of one or more blood capillaries and one of the causes is surgical trauma. Ecchymosis: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot 4-10 cm in diameter, 3 = spot larger than 10 cm in diameter (Metin et al., 2018).
Ecchymosis - 24 hours after treatment [24 hours after treatment]
is bleeding in the subcutaneous tissue, with a diameter greater than 1 cm, which is caused by the rupture of one or more blood capillaries and one of the causes is surgical trauma. Ecchymosis: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot 4-10 cm in diameter, 3 = spot larger than 10 cm in diameter (Metin et al., 2018).
Ecchymosis -7 days after treatment [7 days after treatment]
is bleeding in the subcutaneous tissue, with a diameter greater than 1 cm, which is caused by the rupture of one or more blood capillaries and one of the causes is surgical trauma. Ecchymosis: 0 = no color change, 1 = spot smaller than 4 cm in diameter, 2 = spot 4-10 cm in diameter, 3 = spot larger than 10 cm in diameter (Metin et al., 2018).
Soft tissue healing - baseline [at baseline]
Score 1: no opening at the incision line, no drainage (pus or exudate), no inflammation, no pain. Score 2: no opening at the incision line, no drainage, mild swelling, mild pain. Score 3: no opening at the incision line, active drainage, advanced inflammation, moderate to advanced pain. Score 4: opening at the incision line, active drainage, advanced inflammation, ongoing pain.
Soft tissue healing - 24 hours after treatment [24 hours after treatment]
Score 1: no opening at the incision line, no drainage (pus or exudate), no inflammation, no pain. Score 2: no opening at the incision line, no drainage, mild swelling, mild pain. Score 3: no opening at the incision line, active drainage, advanced inflammation, moderate to advanced pain. Score 4: opening at the incision line, active drainage, advanced inflammation, ongoing pain.
Soft tissue healing -7 days after treatment [7 days after treatment]
Score 1: no opening at the incision line, no drainage (pus or exudate), no inflammation, no pain. Score 2: no opening at the incision line, no drainage, mild swelling, mild pain. Score 3: no opening at the incision line, active drainage, advanced inflammation, moderate to advanced pain. Score 4: opening at the incision line, active drainage, advanced inflammation, ongoing pain.
Bone consolidation - baseline [at baseline]
Periapical radiography will evaluate the changes in the area of the defect (bone density). Periapical radiographs will always be performed with the same equipment using the parallelism technique. The area of the defect will be measured by multiplying the longest mesiodistal and supero-inferior diameters on the radiographs. In all radiographs, the longest diameter of the lesion was measured and the periapical index was evaluated. The periapical index was recorded according to the following parameters: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5-1 mm, 2 = periapical radiolucency with a diameter of 1.1-2 mm, 3 = radiolucency periapical with a diameter of 2.1-4 mm, 4 = periapical radiolucency with a diameter of 4.1-8 mm and 5 = periapical radiolucency greater than 8.1 mm in diameter.
Bone consolidation - 24 hours after treatment [24 hours after treatment]
Periapical radiography will evaluate the changes in the area of the defect (bone density). Periapical radiographs will always be performed with the same equipment using the parallelism technique. The area of the defect will be measured by multiplying the longest mesiodistal and supero-inferior diameters on the radiographs. In all radiographs, the longest diameter of the lesion was measured and the periapical index was evaluated. The periapical index was recorded according to the following parameters: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5-1 mm, 2 = periapical radiolucency with a diameter of 1.1-2 mm, 3 = radiolucency periapical with a diameter of 2.1-4 mm, 4 = periapical radiolucency with a diameter of 4.1-8 mm and 5 = periapical radiolucency greater than 8.1 mm in diameter.
Bone consolidation - 7 days after treatment [7 days after treatment]
Periapical radiography will evaluate the changes in the area of the defect (bone density). Periapical radiographs will always be performed with the same equipment using the parallelism technique. The area of the defect will be measured by multiplying the longest mesiodistal and supero-inferior diameters on the radiographs. In all radiographs, the longest diameter of the lesion was measured and the periapical index was evaluated. The periapical index was recorded according to the following parameters: 0 = no lesion, 1 = periapical radiolucency with a diameter of 0.5-1 mm, 2 = periapical radiolucency with a diameter of 1.1-2 mm, 3 = radiolucency periapical with a diameter of 2.1-4 mm, 4 = periapical radiolucency with a diameter of 4.1-8 mm and 5 = periapical radiolucency greater than 8.1 mm in diameter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Carolina Ratto Tempestini Horliana, Clinical Investigator, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT05935306

Other Study ID Numbers:

Pain after endodontic surgery

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023