Effect of Benzocaine on PainEarly Phase 1NCT06272903
Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns
A Early Phase 1 study testing 20% benzocaine, topical anesthetic and Children's Toothpaste in people with Effect of Benzocaine on Pain, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
Trial summary
The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the… Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Benzocaine on Pain
- What is being tested?
- 20% benzocaine, topical anesthetic and Children's Toothpaste
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 14 Apr 2024to 16 Dec 2024
- Phase
- Early Phase 1
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with asymptomatic non pulpally involved carious primary molars who meet the indications of the HT in Dubai Dental Hospital.
- Children who require same tooth bilateral HT Crowns in either bilateral or diagonal pattern.
- Healthy male and female children, aged 4-10 years (ASA 1) with no conditions that affect sensory input/reaction.
- Children who are verbal and able to communicate.
- Not taking any painkillers, or other drugs that would influence with their pain perception.
- Cooperative children.
- Parents or guardians who consent for their children to be enrolled in the trial.
Who cannot join
- Children who are indicated for bilateral HT but do not require EOS, due to pre-existing interdental spaces.
- Children who are indicated for bilateral HT but parents prefer or indicate preference for the Modified HT.
- Children with allergies to nickel or other metal components that constitute a PMC.
- Those with reported allergies to topical or local anesthetic.
- Children with special health care needs or those who are non-verbal and are unable to communicate their pain levels.
- Children/parents/guardians not willing to participate in the study.
- Patients that require treatment under conscious sedation or general anesthesia.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Mohammed Bin Rashid University Of Medicine and Health Sciences
Dubai
About this study
Official title: The Immediate Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Elastomeric Orthodontic Separators in Children Receiving Hall Technique Crowns: A Randomized Control Trial
The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
Read the detailed description
The primary objective of this RCT is to assess the immediate effect of benzocaine 20% topical anesthesia on the initial pain and discomfort experienced during the placement of elastomeric orthodontic separators in pediatric patients undergoing Hall Technique crowns for their primary molars. This study will be conducted among children aged 4-10 years old, receiving dental care at the Pediatric Dentistry Department of Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, United Arab Emirates (UAE).
The research will involve recruiting a sample of 32 pediatric patients aged between 4 and 10 years who require 2 Hall Technique crowns on their primary molars and are scheduled to undergo the placement of elastomeric orthodontic separators as part of their treatment. The participants will be randomly assigned to receive benzocaine 20% topical anesthesia prior to separator placement on either the right or left side of their mouth, and the other side receiving a placebo (e.g., children's toothpaste) before separator placement.
Data collection: following the placement of elastomeric orthodontic separators, participants will be asked to rate their pain and discomfort levels immediately after the procedure using the Wong-Baker FACES Pain Rating Scale.
In addition to pain and discomfort assessments, demographic data (e.g., age, gender) and clinical information (e.g., specific teeth undergoing treatment) will be collected for each participant. The study will employ rigorous blinding procedures to ensure that the participants are unaware of the assigned treatment (benzocaine or placebo) during the procedure and data collection phases. The principle investigator will only be aware of which side of the mouth will be receiving benzocaine just before the procedure via a sealed envelope randomisation.
Statistical analyses will be conducted to compare the pain and discomfort levels between the two treatment groups. The findings of this study will contribute valuable insights into the efficacy of benzocaine 20% topical anesthesia in managing pain associated with elastomeric orthodontic separator placement in pediatric dental patients undergoing Hall Technique crown procedures. Ultimately, the results will inform clinical practice and improve the quality of care provided to pediatric patients undergoing dental procedures.
- Conditions
- Effect of Benzocaine on Pain
- Being tested
- 20% benzocaine, topical anesthetic, Children's Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% benzocaine, topical anestheticDrug
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.
The benzocaine topical anesthetic will be applied according to standard clinical practice, aiming to provide local anesthesia to the treatment site and minimize discomfort during the procedure (placing elastomeric orthodontic separators).
Children's ToothpasteOther
Strawberry-flavored children's toothpaste available in Dubai, UAE.
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine 20% Topical Anesthesia Arm | Experimental | Participants will be assigned this arm either to their right or left hand side of their mouth. They will receive benzocaine 20% topical anesthesia prior to the placement of elastomeric orthodontic separators.
The topical anesthesia will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure. Receives: Drug: 20% benzocaine, topical anesthetic |
| Placebo (Children's Toothpaste) Arm | Placebo comparator | The other side of the mouth will receive a placebo, which consists of children's toothpaste, prior to the placement of elastomeric orthodontic separators.
The toothpaste will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure. Receives: Other: Children's Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Pain Levels
The primary outcome measure is the immediate pain and discomfort experienced by children following the placement of EOSs in the context of placing them before the Hall Technique Crown is placed. It will be assessed using a standardized pain scale (Wong-Baker Faces pain scale) where the participants will rate their pain levels immediately after the procedure.
Measured: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
Secondary outcomes (1)
Patient Satisfaction During Procedure
I will be gathering feedback from the children regarding their overall satisfaction with the procedure by using the Wong-Baker Faces pain scale. This will enable us to gauge the acceptability of placing the elastomeric orthodontic separators.
Measured: Immediate (within 30 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start14 Apr 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Effect of Benzocaine on 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simran Kaur Sura, Mohammed Bin Rashid University of Medicine and Health Sciences
- Investigators
- Simran Kaur Sura, Principal investigator, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272903
- Sponsor's protocol ID
- MBRU IRB-2023-228
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hussein I, Al Halabi M, Kowash M, Salami A, Ouatik N, Yang YM, Duggal M, Chandwani N, Nazzal H, Albadri S, Roberts A, Al-Jundi S, Nzomiwu C, El Shahawy O, Attaie A, Mohammed O, Al-Sane M. Use of the Hall technique by specialist paediatric dentists: a global perspective. Br Dent J. 2020 Jan;228(1):33-38. doi: 10.1038/s41415-019-1100-2.
PubMed 31925371Boyd DH, Foster Page LA, Moffat SM, Thomson WM. Time to complain about pain: Children's self-reported procedural pain in a randomised control trial of Hall and conventional stainless steel crown techniques. Int J Paediatr Dent. 2023 Jul;33(4):382-393. doi: 10.1111/ipd.13059. Epub 2023 Mar 16.
PubMed 36841968Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.
PubMed 28879311Aghababaie ST, Monteiro J, Stratigaki E, Ashley PF. Techniques for effective local anaesthetic administration for the paediatric patient. Br Dent J. 2020 Dec;229(12):779-785. doi: 10.1038/s41415-020-2453-2. Epub 2020 Dec 18.
PubMed 33339924Bird SE, Williams K, Kula K. Preoperative acetaminophen vs ibuprofen for control of pain after orthodontic separator placement. Am J Orthod Dentofacial Orthop. 2007 Oct;132(4):504-10. doi: 10.1016/j.ajodo.2006.11.019.
PubMed 17920504Farzan A, Khaleghi K. The Effectiveness of Low-Level Laser Therapy in Pain Induced by Orthodontic Separator Placement: A Systematic Review. J Lasers Med Sci. 2021 Jun 24;12:e29. doi: 10.34172/jlms.2021.29. eCollection 2021.
PubMed 34733752Al-Melh MA, Nada A, Badr H, Andersson L. Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement. J Contemp Dent Pract. 2019 Nov 1;20(11):1286-1292.
PubMed 31892680Eslamian L, Borzabadi-Farahani A, Edini HZ, Badiee MR, Lynch E, Mortazavi A. The analgesic effect of benzocaine mucoadhesive patches on orthodontic pain caused by elastomeric separators, a preliminary study. Acta Odontol Scand. 2013 Sep;71(5):1168-73. doi: 10.3109/00016357.2012.757358. Epub 2013 Jan 10.
PubMed 23301559Meechan JG. Intraoral topical anesthesia. Periodontol 2000. 2008;46:56-79. doi: 10.1111/j.1600-0757.2008.00231.x. No abstract available.
PubMed 18201346Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.
PubMed 26154451Garrocho-Rangel A, Ruiz-Rodriguez S, Gaitan-Fonseca C, Pozos-Guillen A. Randomized Clinical Trials in Pediatric Dentistry: Application of Evidence-Based Dentistry through the CONSORT Statement. J Clin Pediatr Dent. 2019;43(4):219-230. doi: 10.17796/1053-4625-43.4.1. Epub 2019 May 16.
PubMed 31094627Eslamian L, Kianipour A, Mortazavi SAR. The Analgesic Efficacy of 5% Naproxen Gel for Pain Associated with Orthodontic Separator Placement: A Randomized Double-Blind Controlled Trial. Anesth Pain Med. 2017 Mar 8;7(2):e42708. doi: 10.5812/aapm.42708. eCollection 2017 Apr.
PubMed 28824857Sura SK, Kowash M, Salami A, Al Halabi M, Khamis AH, Hussein I. Procedural Pain, Hall Technique Crowns and Separators: A Randomized Controlled Clinical Pilot Feasibility Study. Int J Clin Pediatr Dent. 2026 Mar;19(3):357-367. doi: 10.5005/jp-journals-10005-3466. Epub 2026 Mar 2.
PubMed 42339306
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Elastomeric Orthodontic Separators in Children Receiving Hall Technique Crowns: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06272903
- Acronym / sponsor ID
- MBRU IRB-2023-228
- Conditions
- Effect of Benzocaine on Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 22 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 goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
Detailed description
The primary objective of this RCT is to assess the immediate effect of benzocaine 20% topical anesthesia on the initial pain and discomfort experienced during the placement of elastomeric orthodontic separators in pediatric patients undergoing Hall Technique crowns for their primary molars. This study will be conducted among children aged 4-10 years old, receiving dental care at the Pediatric Dentistry Department of Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, United Arab Emirates (UAE).
The research will involve recruiting a sample of 32 pediatric patients aged between 4 and 10 years who require 2 Hall Technique crowns on their primary molars and are scheduled to undergo the placement of elastomeric orthodontic separators as part of their treatment. The participants will be randomly assigned to receive benzocaine 20% topical anesthesia prior to separator placement on either the right or left side of their mouth, and the other side receiving a placebo (e.g., children's toothpaste) before separator placement.
Data collection: following the placement of elastomeric orthodontic separators, participants will be asked to rate their pain and discomfort levels immediately after the procedure using the Wong-Baker FACES Pain Rating Scale.
In addition to pain and discomfort assessments, demographic data (e.g., age, gender) and clinical information (e.g., specific teeth undergoing treatment) will be collected for each participant. The study will employ rigorous blinding procedures to ensure that the participants are unaware of the assigned treatment (benzocaine or placebo) during the procedure and data collection phases. The principle investigator will only be aware of which side of the mouth will be receiving benzocaine just before the procedure via a sealed envelope randomisation.
Statistical analyses will be conducted to compare the pain and discomfort levels between the two treatment groups. The findings of this study will contribute valuable insights into the efficacy of benzocaine 20% topical anesthesia in managing pain associated with elastomeric orthodontic separator placement in pediatric dental patients undergoing Hall Technique crown procedures. Ultimately, the results will inform clinical practice and improve the quality of care provided to pediatric patients undergoing dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzocaine 20% Topical Anesthesia Arm | Experimental | Drug: 20% benzocaine, topical anestheticParticipants will be assigned this arm either to their right or left hand side of their mouth. They will receive benzocaine 20% topical anesthesia prior to the placement of elastomeric orthodontic separators. The topical anesthesia will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure. |
| Placebo (Children's Toothpaste) Arm | Placebo comparator | Other: Children's ToothpasteThe other side of the mouth will receive a placebo, which consists of children's toothpaste, prior to the placement of elastomeric orthodontic separators. The toothpaste will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with asymptomatic non pulpally involved carious primary molars who meet the indications of the HT in Dubai Dental Hospital.
- Children who require same tooth bilateral HT Crowns in either bilateral or diagonal pattern.
- Healthy male and female children, aged 4-10 years (ASA 1) with no conditions that affect sensory input/reaction.
- Children who are verbal and able to communicate.
- Not taking any painkillers, or other drugs that would influence with their pain perception.
Key exclusion criteria (7 listed)
- Children who are indicated for bilateral HT but do not require EOS, due to pre-existing interdental spaces.
- Children who are indicated for bilateral HT but parents prefer or indicate preference for the Modified HT.
- Children with allergies to nickel or other metal components that constitute a PMC.
- Those with reported allergies to topical or local anesthetic.
- Children with special health care needs or those who are non-verbal and are unable to communicate their pain levels.
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 |
|---|---|---|
| 20% benzocaine, topical anestheticIndicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs. The benzocaine topical anesthetic will be applied according to standard clinical practice, aiming to provide local anesthesia to the treatment site and minimize discomfort during the procedure (placing elastomeric orthodontic separators). | Drug | Benzocaine 20% Topical Anesthesia Arm |
| Children's ToothpasteStrawberry-flavored children's toothpaste available in Dubai, UAE. | Other | Placebo (Children's Toothpaste) Arm |
Primary outcome
Immediate Pain Levels
Time frame: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
The primary outcome measure is the immediate pain and discomfort experienced by children following the placement of EOSs in the context of placing them before the Hall Technique Crown is placed. It will be assessed using a standardized pain scale (Wong-Baker Faces pain scale) where the participants will rate their pain levels immediately after the procedure.
1 secondary outcome
Patient Satisfaction During Procedure
Time frame: Immediate (within 30 seconds)
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 19 Mar 2025.
- Results publication: PubMed 31925371Hussein I, Al Halabi M, Kowash M, Salami A, Ouatik N, Yang YM, Duggal M, Chandwani N, Nazzal H, Albadri S, Roberts A, Al-Jundi S, Nzomiwu C, El Shahawy O, Attaie A, Mohammed O, Al-Sane M. Use of the Hall technique by specialist paediatric dentists: a global perspective. Br Dent J. 2020 Jan;228(1):33-38. doi: 10.1038/s41415-019-1100-2.
- Results publication: PubMed 36841968Boyd DH, Foster Page LA, Moffat SM, Thomson WM. Time to complain about pain: Children's self-reported procedural pain in a randomised control trial of Hall and conventional stainless steel crown techniques. Int J Paediatr Dent. 2023 Jul;33(4):382-393. doi: 10.1111/ipd.13059. Epub 2023 Mar 16.
- Results publication: PubMed 28879311Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.
- Results publication: PubMed 33339924Aghababaie ST, Monteiro J, Stratigaki E, Ashley PF. Techniques for effective local anaesthetic administration for the paediatric patient. Br Dent J. 2020 Dec;229(12):779-785. doi: 10.1038/s41415-020-2453-2. Epub 2020 Dec 18.
- Results publication: PubMed 17920504Bird SE, Williams K, Kula K. Preoperative acetaminophen vs ibuprofen for control of pain after orthodontic separator placement. Am J Orthod Dentofacial Orthop. 2007 Oct;132(4):504-10. doi: 10.1016/j.ajodo.2006.11.019.
- Results publication: PubMed 34733752Farzan A, Khaleghi K. The Effectiveness of Low-Level Laser Therapy in Pain Induced by Orthodontic Separator Placement: A Systematic Review. J Lasers Med Sci. 2021 Jun 24;12:e29. doi: 10.34172/jlms.2021.29. eCollection 2021.
- Results publication: PubMed 31892680Al-Melh MA, Nada A, Badr H, Andersson L. Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement. J Contemp Dent Pract. 2019 Nov 1;20(11):1286-1292.
- Results publication: PubMed 23301559Eslamian L, Borzabadi-Farahani A, Edini HZ, Badiee MR, Lynch E, Mortazavi A. The analgesic effect of benzocaine mucoadhesive patches on orthodontic pain caused by elastomeric separators, a preliminary study. Acta Odontol Scand. 2013 Sep;71(5):1168-73. doi: 10.3109/00016357.2012.757358. Epub 2013 Jan 10.
- Results publication: PubMed 18201346Meechan JG. Intraoral topical anesthesia. Periodontol 2000. 2008;46:56-79. doi: 10.1111/j.1600-0757.2008.00231.x. No abstract available.
- Results publication: PubMed 26154451Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.
- Results publication: PubMed 31094627Garrocho-Rangel A, Ruiz-Rodriguez S, Gaitan-Fonseca C, Pozos-Guillen A. Randomized Clinical Trials in Pediatric Dentistry: Application of Evidence-Based Dentistry through the CONSORT Statement. J Clin Pediatr Dent. 2019;43(4):219-230. doi: 10.17796/1053-4625-43.4.1. Epub 2019 May 16.
- Results publication: PubMed 28824857Eslamian L, Kianipour A, Mortazavi SAR. The Analgesic Efficacy of 5% Naproxen Gel for Pain Associated with Orthodontic Separator Placement: A Randomized Double-Blind Controlled Trial. Anesth Pain Med. 2017 Mar 8;7(2):e42708. doi: 10.5812/aapm.42708. eCollection 2017 Apr.
- Individual participant dataSharing planned: No
Related trials for Effect of Benzocaine on Pain
Active, not recruiting
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
We Are Not Studying a Disease or Condition, Pain Reduction
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.
Simran Kaur Sura principal investigator
Mohammed Bin Rashid University of Medicine and Health Sciences
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 20% benzocaine, topical anesthetic and Children's Toothpaste in people with Effect of Benzocaine on Pain, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
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 7 inclusion and 7 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 19 Mar 2025. 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 United Arab Emirates. 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?
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?
Immediate Pain Levels (time frame: Immediate (within 30 seconds of placing elastomeric orthodontic separators)). 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 NCT06272903, which also lists 13 linked publications.
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 19 Mar 2025.