Pain, PostoperativeNCT06253767
Post-Endodontic Instrumentation Pain After in a Single Session Associated With Photobiomodulation
A study testing Endodontic Treatment, Low Level Laser Therapy and Simulation Low Level Laser therapy in people with Pain, Postoperative and Endodontically Treated Teeth, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Endodontically Treated Teeth
- What is being tested?
- Endodontic Treatment, Low Level Laser Therapy and Simulation Low Level Laser therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2022to 13 Jun 2024
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with endodontic involvement in three-rooted (upper molars) or two-rooted (upper premolars) teeth.
- Age between 20 and 75 years.
- Both genders.
Who cannot join
- Pregnancy or lactation.
- Patients with oncological, renal, or Type I or Type II diabetes.
- Drug users; alcohol or tobacco users.
- Immunocompromised patients or those using immunosuppressive medication.
- Use of alendronate, bisphosphonates, or any systemic medication that interferes with bone metabolism.
- Presence of associated periodontal disease.
Show all 14Show fewer
- Frequent exacerbations.
- Radiolucency images with PAI stages 3, 4, or 5 (Orstavik et al., 1986).
- Any other anatomical variation that renders single-session endodontic treatment unfeasible.
- Teeth with previous endodontic treatment.
- Patients with asymptomatic non-microbial apical periodontitis with any type of bruxism (clenching) or using a bite splint.
- Teeth with more than ⅔ coronal involvement, making proper use of rubber dam isolation impossible.
- Use of antibiotics in the last three months.
- History of severe allergy to chlorine or its derivatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study
The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
Read the detailed description
The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
- Conditions
- Pain, Postoperative, Endodontically Treated Teeth
- Being tested
- Endodontic Treatment, Low Level Laser Therapy, Simulation Low Level Laser therapy
- Keywords
- photobiomodulation, analgesia
- Medical subject headings
- Pain, Postoperative, Tooth, Nonvital, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic TreatmentProcedure or surgery
Conventional endodontic treatment will be performed equally on all participants.
Low Level Laser TherapyDevice
Treatment Group (TG) will receive photobiomodulation for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall
Simulation Low Level Laser therapyDevice
A simulation of low-level laser therapy was performed on the control group starting from patient preparation (placement of glasses) and the reproduction of device sounds without activation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (TG) | Experimental | They are composed of 29 participants. After endodontic treatment, they will receive PBM for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall Receives: Procedure: Endodontic Treatment; Device: Low Level Laser Therapy |
| Control Group (CG) | Sham comparator | They are composed of 29 participants. After endodontic treatment, they will receive a simulation of the PBM session with all individual preparation involved, such as individual protection with goggles, and the sounds of the equipment (Laser Duo®, MMOptics, São Carlos, SP) will be recorded and played at the time of the session, but the equipment will not be activated. Receives: Procedure: Endodontic Treatment; Device: Simulation Low Level Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline : Analysis of pain before treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Measured: Immediately before the treatment
Analysis of Postoperative Pain at 4 Hours After Treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 4 hours after the procedure. This scale will be exactly 10 cm and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Measured: 4 hours after treatment
Analysis of Postoperative Pain at 8 Hours After Treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 8 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Measured: 8 hours after treatment
Analysis of Postoperative Pain at 12 Hours After Treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 12 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Measured: 12 hours after treatment
Analysis of Postoperative Pain at 24 Hours After Treatment
24 hours after the root canal filling, whether or not accompanied by photobiomodulation, the patient will return to the clinic for a reassessment of immediate pain. At this moment, the patient will be provided with a visual analog scale consisting of exactly 10 centimeters, with markings of "0" (no pain) and "10" representing maximum pain. The patient will then make a mark on this scale to indicate their current level of pain in the dental element. After the marking, the researcher will measure the distance from zero to the marked point using a millimeter ruler, and the obtained result will be recorded and statistically compared with the preoperative pain.
Measured: 24 hours after treatment
Secondary outcomes (7)
Baseline : Analysis of pain upon palpation before treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Measured: Immediately before the treatment
Analysis of Palpation Pain 24 Hours After Treatment
During the same follow-up appointment 24 hours after endodontic treatment, palpation pain (vestibular and palatal) will be analyzed. The participant, after palpating the vestibular board, will mark on the visual pain scale the level of referred pain, and the same procedure will be done after palpating the palatal bony board.
Measured: 24 hours after treatment
Baseline: Analysis of pain upon percussion before treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Measured: Immediately before the treatment
Analysis of Percussion Pain 24 Hours After Treatment
Percussion pain (vertical and horizontal) will also be assessed 24 hours after treatment. These assessments will be performed by the principal investigator, who is blinded to the treatment administered and properly calibrated.
Measured: 24 hours after treatment
Analysis of the Required Analgesic Quantity
Following the completion of endodontic treatment, all participants will be provided with 750mg Paracetamol tablets, and they will be instructed to take them in case of extreme pain. The quantity of analgesic intake should be noted on the sheet provided for recording pain experiences and returned during the 24-hour follow-up appointment.
Measured: 24 hours after treatment
Oral Health Impact Profile-14
The effects of treatment on participants' quality of life will be assessed using the patient-centered outcome measures from the Oral Health Impact Profile-14 (OHIP-14). The questionnaire will be handed to participants at the end of the treatment, and they will be properly instructed to fill it out and return it during the 24-hour follow-up.
Measured: 24 hours after treatment
Prevalence Analysis
In the prevalence analysis of a particular condition, the frequency of occurrence of the condition, or in this case, the painful condition, in a specific population at a single point in time or a short period will be obtained (Bonita et al., 1993). In this study, the prevalence of pain before and 24 hours after endodontic instrumentation in the single-session treatment of upper molars will be examined.
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start20 Oct 2022
- Primary completion12 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna Carolina RT Horliana, Study chair, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253767
- Sponsor's protocol ID
- 5991.5622.3.0000.5511
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06253767
- Acronym / sponsor ID
- 5991.5622.3.0000.5511
- Conditions
- Pain, Postoperative, Endodontically Treated Teeth
- Keywords
- photobiomodulation, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 12 Feb 2024 (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 double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
Detailed description
The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (TG) | Experimental | Procedure: Endodontic Treatment, Device: Low Level Laser TherapyThey are composed of 29 participants. After endodontic treatment, they will receive PBM for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall |
| Control Group (CG) | Sham comparator | Procedure: Endodontic Treatment, Device: Simulation Low Level Laser therapyThey are composed of 29 participants. After endodontic treatment, they will receive a simulation of the PBM session with all individual preparation involved, such as individual protection with goggles, and the sounds of the equipment (Laser Duo®, MMOptics, São Carlos, SP) will be recorded and played at the time of the session, but the equipment will not be activated. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with endodontic involvement in three-rooted (upper molars) or two-rooted (upper premolars) teeth.
- Age between 20 and 75 years.
- Both genders.
Key exclusion criteria (14 listed)
- Pregnancy or lactation.
- Patients with oncological, renal, or Type I or Type II diabetes.
- Drug users; alcohol or tobacco users.
- Immunocompromised patients or those using immunosuppressive medication.
- Use of alendronate, bisphosphonates, or any systemic medication that interferes with bone metabolism.
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 |
|---|---|---|
| Endodontic TreatmentConventional endodontic treatment will be performed equally on all participants. | Procedure or surgery | Control Group (CG), Treatment Group (TG) |
| Low Level Laser TherapyTreatment Group (TG) will receive photobiomodulation for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall | Device | Treatment Group (TG) |
| Simulation Low Level Laser therapyA simulation of low-level laser therapy was performed on the control group starting from patient preparation (placement of glasses) and the reproduction of device sounds without activation. | Device | Control Group (CG) |
Primary outcome
Baseline : Analysis of pain before treatment
Time frame: Immediately before the treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Analysis of Postoperative Pain at 4 Hours After Treatment
Time frame: 4 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 4 hours after the procedure. This scale will be exactly 10 cm and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Analysis of Postoperative Pain at 8 Hours After Treatment
Time frame: 8 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 8 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Analysis of Postoperative Pain at 12 Hours After Treatment
Time frame: 12 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 12 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Analysis of Postoperative Pain at 24 Hours After Treatment
Time frame: 24 hours after treatment
24 hours after the root canal filling, whether or not accompanied by photobiomodulation, the patient will return to the clinic for a reassessment of immediate pain. At this moment, the patient will be provided with a visual analog scale consisting of exactly 10 centimeters, with markings of "0" (no pain) and "10" representing maximum pain. The patient will then make a mark on this scale to indicate their current level of pain in the dental element. After the marking, the researcher will measure the distance from zero to the marked point using a millimeter ruler, and the obtained result will be recorded and statistically compared with the preoperative pain.
7 secondary outcomes
Baseline : Analysis of pain upon palpation before treatment
Time frame: Immediately before the treatment
Analysis of Palpation Pain 24 Hours After Treatment
Time frame: 24 hours after treatment
Baseline: Analysis of pain upon percussion before treatment
Time frame: Immediately before the treatment
Analysis of Percussion Pain 24 Hours After Treatment
Time frame: 24 hours after treatment
Analysis of the Required Analgesic Quantity
Time frame: 24 hours after treatment
Oral Health Impact Profile-14
Time frame: 24 hours after treatment
Prevalence Analysis
Time frame: 24 hours 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 15 Oct 2024.
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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.
Anna Carolina RT Horliana study chair
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Treatment, Low Level Laser Therapy and Simulation Low Level Laser therapy in people with Pain, Postoperative and Endodontically Treated Teeth, run by University of Nove de Julho at 1 site in Brazil.
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 3 inclusion and 14 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 15 Oct 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Baseline : Analysis of pain before treatment (time frame: Immediately before the treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.