DiscomfortEarly Phase 1NCT07707557
Comparing Pain Levels With or Without Topical Anesthesia During Infiltration Injection in Patients Undergoing Tooth Extraction.
A Early Phase 1 study testing 2% Lidocaine hydrochloride infiltrate injection and 5% topical Lidocaine hydrochloride preparation in people with Discomfort, run by Abbasi Shaheed Hospital at 1 site in Pakistan.
Trial summary
This randomized clinical trial aims to assess whether the application of 5% topical lidocaine before infiltration anesthesia reduces pain in patients undergoing tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Discomfort
- What is being tested?
- 2% Lidocaine hydrochloride infiltrate injection and 5% topical Lidocaine hydrochloride preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 15 Aug 2026
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged 18-65 years of age who underwent extraction of tooth.
- no intolerance or allergies to lidocaine 2% infiltration and lidocaine 5% topical.
- Patients should not take sedative analgesics or anxiety medications in the 12 hour prior to extraction
Who cannot join
- Pregnant or lactating women.
- Patient not giving consent to undergo the procedure.
- Patient with occurrence of skin or mucosal allergy or abnormal reaction at the vascular access site.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Abbasi Shaheed Hospital and Karachi Medical and Dental College
Karachi, Sindh, 74200
About this study
Official title: Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC
This randomized clinical trial aims to assess whether the application of 5% topical lidocaine before infiltration anesthesia reduces pain in patients undergoing tooth extraction. A total of 120 participants will be randomly assigned to receive either infiltration anesthesia alone or infiltration anesthesia preceded by topical lidocaine. Pain will be evaluated using the Visual Analogue Scale (VAS) at predetermined intervals following the procedure. The study seeks to determine the effectiveness of topical anesthesia as a simple adjunctive measure for improving patient comfort and reducing injection-related pain during routine dental extractions. Findings from this research may help optimize pain management strategies and enhance the overall patient experience in dental practice.
Read the detailed description
This randomized clinical trial is designed to evaluate the effectiveness of 5% topical lidocaine in reducing pain associated with infiltration anesthesia in patients undergoing tooth extraction. Pain during local anesthetic administration remains a common cause of anxiety and fear among dental patients and may negatively affect treatment acceptance, patient cooperation, and overall clinical experience.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, and the Department of Oral Surgery, KMDC. A total of 120 eligible adult patients requiring tooth extraction will be recruited after obtaining informed consent. Participants will be randomly allocated into two groups using sealed opaque envelopes. Group A will receive conventional infiltration anesthesia with 2% lidocaine alone, while Group B will receive 5% topical lidocaine prior to administration of 2% lidocaine infiltration anesthesia.
The primary outcome measure will be pain intensity, assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 5, 15, and 30 minutes following the procedure. Relevant demographic and clinical variables, including age, gender, smoking status, diabetes mellitus, and hypertension, will also be collected to evaluate potential confounding factors.
The intervention poses minimal risk to participants, as both topical and infiltrative lidocaine are routinely used and well-established agents in dental practice. Patients with known allergies to lidocaine, pregnant or lactating women, and individuals unwilling to participate will be excluded to ensure participant safety. All participants will receive the standard of care required for tooth extraction irrespective of study allocation.
The anticipated benefit of this study is the generation of evidence regarding the effectiveness of topical anesthesia as an adjunctive measure for reducing injection-related pain. The findings may contribute to improved patient comfort, reduced anxiety, enhanced treatment acceptance, and optimization of pain management protocols in routine dental practice.
- Conditions
- Discomfort
- Being tested
- 2% Lidocaine hydrochloride infiltrate injection, 5% topical Lidocaine hydrochloride preparation
- Keywords
- Topical Lidocaine, Infiltration Anesthesia, Tooth Extraction, Injection Pain, Local Anesthesia, Dental Anxiety.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine hydrochloride infiltrate injectionDrug
Participants assigned to Arm 1 will receive conventional local anesthesia using a 2% lidocaine hydrochloride infiltration injection before tooth extraction. No topical anesthetic will be applied prior to the injection. This arm serves as the control group and represents the standard practice against which the effect of pre-injection topical lidocaine anesthesia will be compared.
5% topical Lidocaine hydrochloride preparationDrug
Participants assigned to Arm 2 will receive 5% topical lidocaine applied to the mucosal injection site before administration of a 2% lidocaine hydrochloride infiltration injection for tooth extraction. The topical anesthetic is administered as a pre-treatment to reduce pain and discomfort associated with needle insertion and anesthetic infiltration. This arm represents the experimental intervention and will be compared with the control group receiving infiltration anesthesia alone.
| Study group | Role | What they receive |
|---|---|---|
| Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone) | Placebo comparator | Arm 1: Control Group Title: 2% lidocaine hydrochloride injection
Description: Participants receive conventional 2% lidocaine hydrochloride infiltration anesthesia without prior application of topical lidocaine. Receives: Drug: 2% Lidocaine hydrochloride infiltrate injection |
| A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti | Experimental | Arm 2: Experimental Group
Title: Topical 5% Lidocaine hydrochloride preparation Plus 2% lidocaine hydrochloride Infiltration injection
Description: Participants receive 5% topical lidocaine hydrochloride preparation before administration of 2% lidocaine hydrochloride infiltration injection. Receives: Drug: 2% Lidocaine hydrochloride infiltrate injection; Drug: 5% topical Lidocaine hydrochloride preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure
Measured: 5 minutes, 15 minutes, and 30 minutes post-procedure
Pain Score (Visual Analogue Scale)
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure.
Measured: 5 minutes, 15 minutes, and 30 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Dec 2025
- Primary completion4 Jun 2026
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiscomfortStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbasi Shaheed Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farwa Ghulam, Abbasi Shaheed Hospital
- Investigators
- FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY, Principal investigator, Abbasi Shaheed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707557
- Sponsor's protocol ID
- IRB/KMDC/KMU/26/2025
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC
- ClinicalTrials.gov ID
- NCT07707557
- Acronym / sponsor ID
- IRB/KMDC/KMU/26/2025
- Conditions
- Discomfort
- Keywords
- Topical Lidocaine, Infiltration Anesthesia, Tooth Extraction, Injection Pain, Local Anesthesia, Dental Anxiety.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abbasi Shaheed HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 16 Jul 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.
This randomized clinical trial aims to assess whether the application of 5% topical lidocaine before infiltration anesthesia reduces pain in patients undergoing tooth extraction. A total of 120 participants will be randomly assigned to receive either infiltration anesthesia alone or infiltration anesthesia preceded by topical lidocaine. Pain will be evaluated using the Visual Analogue Scale (VAS) at predetermined intervals following the procedure. The study seeks to determine the effectiveness of topical anesthesia as a simple adjunctive measure for improving patient comfort and reducing injection-related pain during routine dental extractions. Findings from this research may help optimize pain management strategies and enhance the overall patient experience in dental practice.
Detailed description
This randomized clinical trial is designed to evaluate the effectiveness of 5% topical lidocaine in reducing pain associated with infiltration anesthesia in patients undergoing tooth extraction. Pain during local anesthetic administration remains a common cause of anxiety and fear among dental patients and may negatively affect treatment acceptance, patient cooperation, and overall clinical experience.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, and the Department of Oral Surgery, KMDC. A total of 120 eligible adult patients requiring tooth extraction will be recruited after obtaining informed consent. Participants will be randomly allocated into two groups using sealed opaque envelopes. Group A will receive conventional infiltration anesthesia with 2% lidocaine alone, while Group B will receive 5% topical lidocaine prior to administration of 2% lidocaine infiltration anesthesia.
The primary outcome measure will be pain intensity, assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 5, 15, and 30 minutes following the procedure. Relevant demographic and clinical variables, including age, gender, smoking status, diabetes mellitus, and hypertension, will also be collected to evaluate potential confounding factors.
The intervention poses minimal risk to participants, as both topical and infiltrative lidocaine are routinely used and well-established agents in dental practice. Patients with known allergies to lidocaine, pregnant or lactating women, and individuals unwilling to participate will be excluded to ensure participant safety. All participants will receive the standard of care required for tooth extraction irrespective of study allocation.
The anticipated benefit of this study is the generation of evidence regarding the effectiveness of topical anesthesia as an adjunctive measure for reducing injection-related pain. The findings may contribute to improved patient comfort, reduced anxiety, enhanced treatment acceptance, and optimization of pain management protocols in routine dental practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone) | Placebo comparator | Drug: 2% Lidocaine hydrochloride infiltrate injectionArm 1: Control Group Title: 2% lidocaine hydrochloride injection Description: Participants receive conventional 2% lidocaine hydrochloride infiltration anesthesia without prior application of topical lidocaine. |
| A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti | Experimental | Drug: 2% Lidocaine hydrochloride infiltrate injection, Drug: 5% topical Lidocaine hydrochloride preparationArm 2: Experimental Group Title: Topical 5% Lidocaine hydrochloride preparation Plus 2% lidocaine hydrochloride Infiltration injection Description: Participants receive 5% topical lidocaine hydrochloride preparation before administration of 2% lidocaine hydrochloride infiltration injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 18-65 years of age who underwent extraction of tooth.
- no intolerance or allergies to lidocaine 2% infiltration and lidocaine 5% topical.
- Patients should not take sedative analgesics or anxiety medications in the 12 hour prior to extraction
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Patient not giving consent to undergo the procedure.
- Patient with occurrence of skin or mucosal allergy or abnormal reaction at the vascular access site.
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 |
|---|---|---|
| 2% Lidocaine hydrochloride infiltrate injectionParticipants assigned to Arm 1 will receive conventional local anesthesia using a 2% lidocaine hydrochloride infiltration injection before tooth extraction. No topical anesthetic will be applied prior to the injection. This arm serves as the control group and represents the standard practice against which the effect of pre-injection topical lidocaine anesthesia will be compared. | Drug | A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti, Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone) |
| 5% topical Lidocaine hydrochloride preparationParticipants assigned to Arm 2 will receive 5% topical lidocaine applied to the mucosal injection site before administration of a 2% lidocaine hydrochloride infiltration injection for tooth extraction. The topical anesthetic is administered as a pre-treatment to reduce pain and discomfort associated with needle insertion and anesthetic infiltration. This arm represents the experimental intervention and will be compared with the control group receiving infiltration anesthesia alone. | Drug | A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti |
Primary outcome
Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
Time frame: 5 minutes, 15 minutes, and 30 minutes post-procedure
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure
Pain Score (Visual Analogue Scale)
Time frame: 5 minutes, 15 minutes, and 30 minutes post-procedure
Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure.
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY principal investigator
Abbasi Shaheed Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 2% Lidocaine hydrochloride infiltrate injection and 5% topical Lidocaine hydrochloride preparation in people with Discomfort, run by Abbasi Shaheed Hospital 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 3 inclusion and 3 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 16 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale (time frame: 5 minutes, 15 minutes, and 30 minutes post-procedure). The study lists 2 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 16 Jul 2026.