PainNCT05306470
Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa
A study testing Ethyl chloride and 5% lidocaine gel in people with Pain and Symptomatic Irreversible Pulpitis, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Ethyl chloride and 5% lidocaine gel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 30 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- No medical history
- No age restrictions
- Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration
Who cannot join
- Patients having any medical conditions considered to affect patient safety or the quality of the study
- if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial
Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. My study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.
Read the detailed description
Local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . It is a job of the dentist to provide a painless dental treatment from the very beginning. Most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. Dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . Numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient.
Pain level is assigned to one of four categorical scores using visual analogue scale
- :None(0)
- : Mild (1-3)
- : Moderate (4-6)
- : Severe (7-10)
- Conditions
- Pain, Symptomatic Irreversible Pulpitis
- Being tested
- Ethyl chloride, 5% lidocaine gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl chlorideProcedure or surgery
Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic
5% lidocaine gelProcedure or surgery
Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Ethyl chloride | Experimental | Pre cooling done by the application of single spray ethyl chloride on a cotton pellet and placed for 30 seconds at the injection site for numbing effect Receives: Procedure: Ethyl chloride |
| 5% lidocaine gel | Experimental | 5% lidocaine gel 2ml applied on a cotton pallet for 30 seconds on the oral mucosa at the site of injection for the numbing effect Receives: Procedure: 5% lidocaine gel |
| control | No intervention | Local anesthesia infiltration is administrated without using any numbing agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post oral local anesthetic infiltration pain
Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
Measured: immediately after completion of administration of oral local anesthetic infiltration within 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306470
- Sponsor's protocol ID
- Local Anesthetic
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05306470
- Acronym / sponsor ID
- Local Anesthetic
- Conditions
- Pain, Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Apr 2022 (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.
Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. My study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.
Detailed description
Local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . It is a job of the dentist to provide a painless dental treatment from the very beginning. Most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. Dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . Numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient.
Pain level is assigned to one of four categorical scores using visual analogue scale
- :None(0)
- : Mild (1-3)
- : Moderate (4-6)
- : Severe (7-10)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethyl chloride | Experimental | Procedure: Ethyl chloridePre cooling done by the application of single spray ethyl chloride on a cotton pellet and placed for 30 seconds at the injection site for numbing effect |
| 5% lidocaine gel | Experimental | Procedure: 5% lidocaine gel5% lidocaine gel 2ml applied on a cotton pallet for 30 seconds on the oral mucosa at the site of injection for the numbing effect |
| control | No intervention | –Local anesthesia infiltration is administrated without using any numbing agent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- No medical history
- No age restrictions
- Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration
Key exclusion criteria (2 listed)
- Patients having any medical conditions considered to affect patient safety or the quality of the study
- if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
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 |
|---|---|---|
| Ethyl chlorideApplication of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic | Procedure or surgery | Ethyl chloride |
| 5% lidocaine gelApplication of 5% lidocaine gel to numb the area for oral infiltration anesthetic | Procedure or surgery | 5% lidocaine gel |
Primary outcome
Post oral local anesthetic infiltration pain
Time frame: immediately after completion of administration of oral local anesthetic infiltration within 60 seconds
Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
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 24 Aug 2022.
- 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.
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 Ethyl chloride and 5% lidocaine gel in people with Pain and Symptomatic Irreversible Pulpitis, run by Altamash Institute of Dental Medicine 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 2 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 24 Aug 2022. 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?
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?
Post oral local anesthetic infiltration pain (time frame: immediately after completion of administration of oral local anesthetic infiltration within 60 seconds). 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 24 Aug 2022.