Chewing FunctionNCT07651774
Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator Placement
A study testing Low Level Laser Therapy in people with Chewing Function and Low Level Laser Therapy, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The objective of this study is to determine the efficacy of LLLT at a wavelength of 635 nm on: Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Chewing Function, Low Level Laser Therapy, Pain
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jun 2022to 15 Jan 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy and complete dentition including permanent second molars.
- Good oral hygiene (absence of generalized calculus deposits assessed clinically).
Who cannot join
- Patients on pain killers or anti-inflammatory medication.
- Spacing between molars and premolars.
- History of diabetes mellitus, epilepsy or any other medical condition.
- Ongoing periodontal disease.
- Past history of orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 635-nm Low-Level Laser Therapy on Spontaneous and Chewing Pain After Orthodontic Elastomeric Separator Placement: A Split-mouth Randomized Controlled Trial
The objective of this study is to determine the efficacy of LLLT at a wavelength of 635 nm on:
- Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators.
- Chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators Study design: Randomized Controlled Trial (split-mouth study). Setting: Department of Orthodontics, Foundation University College of Dentistry \& Hospital (FUCD\&H).
Read more
Duration of study: Six months after approval of synopsis. Sample size: 80 By using WHO calculator the sample size is 80, 40 sample in each group.
Sampling method: Purposive sampling.
Data Collection Procedure:
- Permission has been taken and already submitted from the Ethical Committee of Foundation University College of Dentistry \& Hospital (FUCD\&H), for the study.
- An informed written consent of the patient will be obtained on consent form. (Annexure-A)
- Patients reporting to orthodontic department of FUCD\&H for orthodontic treatment fulfilling the inclusion criteria in our sample will be selected after history, clinical examination \& radiographic evaluation.
- Four elastomeric separators will be placed by an orthodontic resident, using dental floss, for the first permanent molars (distal and mesial), either on maxillary or mandibular arches with a split mouth study design.
- Allocation of quadrant will be randomized by simple randomization method in which experimental side will be randomly allocated to the patient and opposite side of the same patient will act as control.
- Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each.
- The vertical level of laser application will be approximately at the center of the root with the fiber tip of the laser placed nearly perpendicular in close contact with the gingival tissue.
- For the placebo quadrant, a similar procedure will be carried out but with no laser irradiation, without the patient's knowledge.
- After 24 hours, patients will return to the clinic and receive the laser irradiation on the same quadrant.
- After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both jaws immediately at hour 0 (before laser irradiation), after 6, 24, and 30 h, and on the days 3, 4, 5, 6, and 7.
- All the procedural observation will be carried out by the trainee researcher himself, under the supervision of his Supervisor.
- Patient will submit the VAS to the trainee researcher on day 8.
Read the detailed description
Objective:
To determine the efficacy of LLLT at a wavelength of 635 nm on:
- Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators.
- Chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators
MATERIALS AND METHODS:
Study design: Randomized Controlled Trial (split-mouth study). Setting: Department of Orthodontics, Foundation University College of Dentistry \& Hospital (FUCD\&H).
Duration of study: Six months after approval of synopsis. Sample size: 80 By using WHO calculator the sample size is 80, 40 sample in each group, level of significance 5 %, power of test 90 %, Population standard deviation = 1.95510, group 1 mean(S.D) 3.00 ± 2.31, group 2 mean(S.D ) 1.58 ± 1.60.
Sampling method: Purposive sampling.
Sample selection:
Inclusion criteria:
- Both male and female patients.
- 15-30 years of age.
- Healthy and complete dentition including permanent second molars.
- Good oral hygiene (absence of generalized calculus deposits assessed clinically).
Exclusion criteria:
- Patients on pain killers or anti-inflammatory medication.
- Spacing between molars and premolars.
- History of diabetes mellitus, epilepsy or any other medical condition.
- Ongoing periodontal disease.
- Past history of orthodontic treatment.
Data Collection Procedure:
- Permission has been taken and already submitted from the Ethical Committee of Foundation University College of Dentistry \& Hospital (FUCD\&H), for the study.
- An informed written consent of the patient will be obtained on consent form. (Annexure-A)
- Patients reporting to orthodontic department of FUCD\&H for orthodontic treatment fulfilling the inclusion criteria in our sample will be selected after history, clinical examination \& radiographic evaluation.
- Four elastomeric separators will be placed by an orthodontic resident, using dental floss, for the first permanent molars (distal and mesial), either on maxillary or mandibular arches with a split mouth study design.
- Allocation of quadrant will be randomized by simple randomization method in which experimental side will be randomly allocated to the patient and opposite side of the same patient will act as control.
- Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each.
- The vertical level of laser application will be approximately at the center of the root with the fiber tip of the laser placed nearly perpendicular in close contact with the gingival tissue.
- For the placebo quadrant, a similar procedure will be carried out but with no laser irradiation, without the patient's knowledge.
- After 24 hours, patients will return to the clinic and receive the laser irradiation on the same quadrant.
- After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both jaws immediately at hour 0 (before laser irradiation), after 6, 24, and 30 h, and on the days 3, 4, 5, 6, and 7.
- All the procedural observation will be carried out by the trainee researcher himself, under the supervision of his Supervisor.
- Patient will submit the VAS to the trainee researcher on day 8.
Data Analysis Procedure:
Data will be coded and analyzed using SPSS version 24.0. Mean and Standard deviation will be calculated for quantitative variables. Frequency and percentages will be calculated for qualitative variables. Independent samples t tests will be applied to compare the mean pain scores between the experimental and the placebo sides for spontaneous and pain on chewing. P value will be set at 0.05 with a 95% confidence interval. Value less than 0.05 will be considered significant.
- Being tested
- Low Level Laser Therapy, Control
- Keywords
- Elastomeric separators, Orthodontics, Orthodontic Pain, Chewing Pain, Spontaneous pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
- Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each
ControlDevice
No therapy given
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy | Experimental | Effect of LLLT on pain associated with separator placement Receives: Device: Low Level Laser Therapy |
| Control Group | Placebo comparator | No Therapy provided Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous and chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators with Visual Analogue Scale (VAS)
- After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours, and on the days 3, 4, 5, 6, and 7.
Measured: pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours , and on the days 3, 4, 5, 6, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start2 Jun 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chewing FunctionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651774
- Sponsor's protocol ID
- FUCD-Ortho- 2603
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy Reasons
Publications
1. Shi Q, Yang S, Jia F, Xu J. Does low level laser therapy relieve the pain caused by the placement of the orthodontic separators? a meta-analysis. Head Face Med. 2015;11(1):1-9. 2. Ortega SM, Gonçalves ML, da Silva T, Horliana AC, Motta LJ, Altavista OM, Olivan SR, Dos Santos AE, Martimbianco AL, Mesquita-Ferrari RA, Fernandes KP. Evaluation of the use of photobiomodulation following the placement of elastomeric separators: protocol for a randomized controlled clinical trial. J of Med. 2019;98(43). 3. Marini I, Bartolucci ML, Bortolotti F, Innocenti G, Gatto MR, Bonetti GA. The effect of diode superpulsed low-level laser therapy on experimental orthodontic pain caused by elastomeric separators: a randomized controlled clinical trial. Lasers Med Sci. 2015;30(1):35-41. 4. Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain: a single-blind randomized clinical trial. Angle Orthod. 2013;83(4):611-6. 5. Tamgonda S, Reddy YM, Raj KP, Reddy R, Dharamdeep G. Effect of Low Level Laser Therapy: A Novel Approach to Diminish Pain Associated With Elastomeric Separators. Annals of International Med and Dent Research. 2019;5(6):38.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 635-nm Low-Level Laser Therapy on Spontaneous and Chewing Pain After Orthodontic Elastomeric Separator Placement: A Split-mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07651774
- Acronym / sponsor ID
- FUCD-Ortho- 2603
- Keywords
- Elastomeric separators, Orthodontics, Orthodontic Pain, Chewing Pain, Spontaneous pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 16 Jun 2026 (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 study is to determine the efficacy of LLLT at a wavelength of 635 nm on:
- Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators.
- Chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators Study design: Randomized Controlled Trial (split-mouth study). Setting: Department of Orthodontics, Foundation University College of Dentistry \& Hospital (FUCD\&H).
Duration of study: Six months after approval of synopsis. Sample size: 80 By using WHO calculator the sample size is 80, 40 sample in each group.
Sampling method: Purposive sampling.
Data Collection Procedure:
- Permission has been taken and already submitted from the Ethical Committee of Foundation University College of Dentistry \& Hospital (FUCD\&H), for the study.
- An informed written consent of the patient will be obtained on consent form. (Annexure-A)
- Patients reporting to orthodontic department of FUCD\&H for orthodontic treatment fulfilling the inclusion criteria in our sample will be selected after history, clinical examination \& radiographic evaluation.
- Four elastomeric separators will be placed by an orthodontic resident, using dental floss, for the first permanent molars (distal and mesial), either on maxillary or mandibular arches with a split mouth study design.
- Allocation of quadrant will be randomized by simple randomization method in which experimental side will be randomly allocated to the patient and opposite side of the same patient will act as control.
- Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each.
- The vertical level of laser application will be approximately at the center of the root with the fiber tip of the laser placed nearly perpendicular in close contact with the gingival tissue.
- For the placebo quadrant, a similar procedure will be carried out but with no laser irradiation, without the patient's knowledge.
- After 24 hours, patients will return to the clinic and receive the laser irradiation on the same quadrant.
- After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both jaws immediately at hour 0 (before laser irradiation), after 6, 24, and 30 h, and on the days 3, 4, 5, 6, and 7.
- All the procedural observation will be carried out by the trainee researcher himself, under the supervision of his Supervisor.
- Patient will submit the VAS to the trainee researcher on day 8.
Detailed description
Objective:
To determine the efficacy of LLLT at a wavelength of 635 nm on:
- Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators.
- Chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators
MATERIALS AND METHODS:
Study design: Randomized Controlled Trial (split-mouth study). Setting: Department of Orthodontics, Foundation University College of Dentistry \& Hospital (FUCD\&H).
Duration of study: Six months after approval of synopsis. Sample size: 80 By using WHO calculator the sample size is 80, 40 sample in each group, level of significance 5 %, power of test 90 %, Population standard deviation = 1.95510, group 1 mean(S.D) 3.00 ± 2.31, group 2 mean(S.D ) 1.58 ± 1.60.
Sampling method: Purposive sampling.
Sample selection:
Inclusion criteria:
- Both male and female patients.
- 15-30 years of age.
- Healthy and complete dentition including permanent second molars.
- Good oral hygiene (absence of generalized calculus deposits assessed clinically).
Exclusion criteria:
- Patients on pain killers or anti-inflammatory medication.
- Spacing between molars and premolars.
- History of diabetes mellitus, epilepsy or any other medical condition.
- Ongoing periodontal disease.
- Past history of orthodontic treatment.
Data Collection Procedure:
- Permission has been taken and already submitted from the Ethical Committee of Foundation University College of Dentistry \& Hospital (FUCD\&H), for the study.
- An informed written consent of the patient will be obtained on consent form. (Annexure-A)
- Patients reporting to orthodontic department of FUCD\&H for orthodontic treatment fulfilling the inclusion criteria in our sample will be selected after history, clinical examination \& radiographic evaluation.
- Four elastomeric separators will be placed by an orthodontic resident, using dental floss, for the first permanent molars (distal and mesial), either on maxillary or mandibular arches with a split mouth study design.
- Allocation of quadrant will be randomized by simple randomization method in which experimental side will be randomly allocated to the patient and opposite side of the same patient will act as control.
- Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each.
- The vertical level of laser application will be approximately at the center of the root with the fiber tip of the laser placed nearly perpendicular in close contact with the gingival tissue.
- For the placebo quadrant, a similar procedure will be carried out but with no laser irradiation, without the patient's knowledge.
- After 24 hours, patients will return to the clinic and receive the laser irradiation on the same quadrant.
- After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both jaws immediately at hour 0 (before laser irradiation), after 6, 24, and 30 h, and on the days 3, 4, 5, 6, and 7.
- All the procedural observation will be carried out by the trainee researcher himself, under the supervision of his Supervisor.
- Patient will submit the VAS to the trainee researcher on day 8.
Data Analysis Procedure:
Data will be coded and analyzed using SPSS version 24.0. Mean and Standard deviation will be calculated for quantitative variables. Frequency and percentages will be calculated for qualitative variables. Independent samples t tests will be applied to compare the mean pain scores between the experimental and the placebo sides for spontaneous and pain on chewing. P value will be set at 0.05 with a 95% confidence interval. Value less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Experimental | Device: Low Level Laser TherapyEffect of LLLT on pain associated with separator placement |
| Control Group | Placebo comparator | Device: ControlNo Therapy provided |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy and complete dentition including permanent second molars.
- Good oral hygiene (absence of generalized calculus deposits assessed clinically).
Key exclusion criteria (5 listed)
- Patients on pain killers or anti-inflammatory medication.
- Spacing between molars and premolars.
- History of diabetes mellitus, epilepsy or any other medical condition.
- Ongoing periodontal disease.
- Past history of orthodontic treatment.
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 |
|---|---|---|
| Low Level Laser Therapy• Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each | Device | Low Level Laser Therapy |
| ControlNo therapy given | Device | Control Group |
Primary outcome
Spontaneous and chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators with Visual Analogue Scale (VAS)
Time frame: pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours , and on the days 3, 4, 5, 6, and 7.
• After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours, and on the days 3, 4, 5, 6, and 7.
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 13 Aug 2026.
- Background1. Shi Q, Yang S, Jia F, Xu J. Does low level laser therapy relieve the pain caused by the placement of the orthodontic separators? a meta-analysis. Head Face Med. 2015;11(1):1-9. 2. Ortega SM, Gonçalves ML, da Silva T, Horliana AC, Motta LJ, Altavista OM, Olivan SR, Dos Santos AE, Martimbianco AL, Mesquita-Ferrari RA, Fernandes KP. Evaluation of the use of photobiomodulation following the placement of elastomeric separators: protocol for a randomized controlled clinical trial. J of Med. 2019;98(43). 3. Marini I, Bartolucci ML, Bortolotti F, Innocenti G, Gatto MR, Bonetti GA. The effect of diode superpulsed low-level laser therapy on experimental orthodontic pain caused by elastomeric separators: a randomized controlled clinical trial. Lasers Med Sci. 2015;30(1):35-41. 4. Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain: a single-blind randomized clinical trial. Angle Orthod. 2013;83(4):611-6. 5. Tamgonda S, Reddy YM, Raj KP, Reddy R, Dharamdeep G. Effect of Low Level Laser Therapy: A Novel Approach to Diminish Pain Associated With Elastomeric Separators. Annals of International Med and Dent Research. 2019;5(6):38.
- Individual participant dataSharing planned: No. Privacy Reasons
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Chewing Function and Low Level Laser Therapy, run by Foundation University Islamabad at 1 site in Pakistan.
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 2 inclusion and 5 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 13 Aug 2026. 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 Pakistan. 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?
Spontaneous and chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators with Visual Analogue Scale (VAS) (time frame: pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours , and on the days 3, 4, 5, 6, and 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07651774, which also lists 1 linked publication.
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 13 Aug 2026.