- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935306
Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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:
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. |
Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)
Other Names:
. 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain in postoperative period - baseline
Time Frame: 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).
|
at baseline
|
Pain in postoperative period - 24 hours after treatment
Time Frame: 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).
|
24 hours after treatment
|
Pain in postoperative period -7 days after treatment
Time Frame: 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).
|
7 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity of painkillers ingested in the period - baseline
Time Frame: 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).
|
at baseline
|
Quantity of painkillers ingested in the period - 24 hours after treatment
Time Frame: 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).
|
24 hours after treatment
|
Quantity of painkillers ingested in the period - 7 days after treatment
Time Frame: 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).
|
7 days after treatment
|
Edema - baseline
Time Frame: 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).
|
at baseline
|
Edema - 24 hours after treatment
Time Frame: 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).
|
24 hours after treatment
|
Edema - 7 days after treatment
Time Frame: 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).
|
7 days after treatment
|
Ecchymosis - baseline
Time Frame: 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).
|
at baseline
|
Ecchymosis - 24 hours after treatment
Time Frame: 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).
|
24 hours after treatment
|
Ecchymosis -7 days after treatment
Time Frame: 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).
|
7 days after treatment
|
Soft tissue healing - baseline
Time Frame: 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.
|
at baseline
|
Soft tissue healing - 24 hours after treatment
Time Frame: 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.
|
24 hours after treatment
|
Soft tissue healing -7 days after treatment
Time Frame: 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.
|
7 days after treatment
|
Bone consolidation - baseline
Time Frame: 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.
|
at baseline
|
Bone consolidation - 24 hours after treatment
Time Frame: 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.
|
24 hours after treatment
|
Bone consolidation - 7 days after treatment
Time Frame: 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.
|
7 days after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Tooth Diseases
- Pain, Postoperative
- Inflammation
- Dental Pulp Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- Pain after endodontic surgery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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