We Are Not Studying a Disease or ConditionNCT07558720
Effect of Diode Laser and 20% Benzocaine Anesthetic Gel on Pain Reduction Following Tooth Separation With Elastomeric Separators in Fixed Orthodontic Patients: A Randomized Trial in Karachi-Pakistan
A study testing Laser and Benzocaine 20% in people with We Are Not Studying a Disease or Condition and Pain Reduction, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if low level laser therapy works equivalent to benzocaine in reducing the pain caused by separators in fixed orthodontic treatment. The main questions it aims to answer are: Is there any difference in mean pain scores with Low Level Laser Therapy (LLLT) and 20% Benzocaine… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- We Are Not Studying a Disease or Condition, Pain Reduction
- What is being tested?
- Laser and Benzocaine 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Patient aged 18-25 years
- no history of previous orthodontic treatment
- healthy and complete erupted dentition including permanent second molars
- good periodontal health( on basis of periodontal index)
- Tight proximal contacts of all permanent first molars (both mesially and distally)
Who cannot join
- - Patients with multiple fillings, root canal treatments, gingivitis,, missing teeth, or spacing between molars and premolars will be excluded from the sample
- Severely rotated teeth
- posterior open bite
- any systematic disease
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if low level laser therapy works equivalent to benzocaine in reducing the pain caused by separators in fixed orthodontic treatment. The main questions it aims to answer are:
Is there any difference in mean pain scores with Low Level Laser Therapy (LLLT) and 20% Benzocaine anesthetic gel of patients receiving elastomeric separators in fixed orthodontic treatment?
Read more
Researchers will compare low level laser therapy to benzoaine gel to evaluate reduction in pain
Participants will be applied low level laser at the appointment of separator placement and patient himself will apply benzocaine gel thrice daily at the site of separator placement. patient will use placebo on the other side. Gel and placebo would be applied for one month.
Patient will take the gel for 7 days.
- Being tested
- Laser, Benzocaine 20%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserOther
Low level laser therapy will be used to reduce pain
Benzocaine 20%Other
20% benzocaine gel to be administered by patient himself
| Study group | Role | What they receive |
|---|---|---|
| Laser arm | Experimental | Not described Receives: Other: Benzocaine 20% |
| benzocaine arm | Active comparator | 20% benzocaine gel to be administered by patient Receives: Other: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean difference in pain scores
mean difference in pain scores between the two treatments (LLLT and benzocaine gel)
Measured: from day of separator placement for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Dec 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Are Not Studying a Disease or ConditionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ashfaq, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558720
- Sponsor's protocol ID
- 3957
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diode Laser and 20% Benzocaine Anesthetic Gel on Pain Reduction Following Tooth Separation With Elastomeric Separators in Fixed Orthodontic Patients: A Randomized Trial in Karachi-Pakistan
- ClinicalTrials.gov ID
- NCT07558720
- Acronym / sponsor ID
- 3957
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Apr 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 goal of this clinical trial is to learn if low level laser therapy works equivalent to benzocaine in reducing the pain caused by separators in fixed orthodontic treatment. The main questions it aims to answer are:
Is there any difference in mean pain scores with Low Level Laser Therapy (LLLT) and 20% Benzocaine anesthetic gel of patients receiving elastomeric separators in fixed orthodontic treatment?
Researchers will compare low level laser therapy to benzoaine gel to evaluate reduction in pain
Participants will be applied low level laser at the appointment of separator placement and patient himself will apply benzocaine gel thrice daily at the site of separator placement. patient will use placebo on the other side. Gel and placebo would be applied for one month.
Patient will take the gel for 7 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser arm | Experimental | Other: Benzocaine 20% |
| benzocaine arm | Active comparator | Other: Laser20% benzocaine gel to be administered by patient |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Patient aged 18-25 years
- no history of previous orthodontic treatment
- healthy and complete erupted dentition including permanent second molars
- good periodontal health( on basis of periodontal index)
- Tight proximal contacts of all permanent first molars (both mesially and distally)
Key exclusion criteria (4 listed)
- - Patients with multiple fillings, root canal treatments, gingivitis,, missing teeth, or spacing between molars and premolars will be excluded from the sample
- Severely rotated teeth
- posterior open bite
- any systematic disease
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 |
|---|---|---|
| LaserLow level laser therapy will be used to reduce pain | Other | benzocaine arm |
| Benzocaine 20%20% benzocaine gel to be administered by patient himself | Other | Laser arm |
Primary outcome
mean difference in pain scores
Time frame: from day of separator placement for 7 days
mean difference in pain scores between the two treatments (LLLT and benzocaine gel)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Laser and Benzocaine 20% in people with We Are Not Studying a Disease or Condition and Pain Reduction, run by Dow University of Health Sciences 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
mean difference in pain scores (time frame: from day of separator placement for 7 days). 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 30 Apr 2026.