Dental Caries in ChildrenNCT06011005
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.
A study testing Ethyl Chloride spray (group A) and Benzocaine gel 20% (group B) in people with Dental Caries in Children and Anesthesia, Local, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
Trial summary
The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Anesthesia, Local, Injection Site Discomfort
- What is being tested?
- Ethyl Chloride spray (group A) and Benzocaine gel 20% (group B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2023to 31 Dec 2023
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children (ASA I) aged between 7 - 10 years old.
- Needing any maxillary buccal infiltration (anterior, middle, posterior)
- Had no prior history of local anesthesia.
- Frankl behavior III or IV
- Not taking any painkillers, or other drugs that would influence with their pain perception.
Who cannot join
- History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
- Active pathology at the site of injection.
- Prior history of intra-oral injection.
- Frankl behavior I or II.
- Children/parents not willing to participate in the study. § Needle phobia.
- Patients require treatment under conscious sedation.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Mohammed Bin Rashid University Of Medicine and Health Sciences
Multiple Locations
Anas Alsalami, 971508998048, anas.alsalami@mbru.ac.ae
Nagah Abdelrahman
About this study
Official title: Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.
The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
The main question[s] it aims to answer are:
Read more
- How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%?
Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.
Read the detailed description
Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.
- Being tested
- Ethyl Chloride spray (group A), Benzocaine gel 20% (group B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl Chloride spray (group A)Other
Cold test spray
Benzocaine gel 20% (group B)Other
Topical analgesia
| Study group | Role | What they receive |
|---|---|---|
| (Group A) Ethyl Chloride (EC) | Experimental | Topical application for 30 sec. Receives: Other: Ethyl Chloride spray (group A) |
| (Group B) Benzocaine gel 20% (BC) | Active comparator | BC 20% Topical gel application for 30 sec and left for 1 minute. Receives: Other: Benzocaine gel 20% (group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.
Measured: 5-10 minutes
Secondary outcomes (3)
Sound, Eye, Motor (SEM) Index
During the insertion of the needle, the operator will evaluate the patient's behavior for pain perception using sound, eye, motor (SEM) scale and visual analog scale (VAS).
Measured: 5-10 minutes
Visual Analog Scale (VAS)
The VAS scale is a 100-mm long horizontal line labeled "no pain: at one end and "worst pain possible" at the other. After each procedure (EC or BC), the participants are asked to evaluate the degree of pain (primary outcome) they experienced using the Facial Pain Scale below.
Measured: 5-10 minutes
Face Pain Scale
These faces show how much something can hurt. This face (point to leftmost face] shows no pain. The faces show more and more pain [point to each from left to the right] up to this one [point to rightmost face] - it shows very much pain. Point to the face that shows how much the child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ''0' = 'no pain' and ''10' = 'very much pain. Do not use words like "happy' and ''sad'. This scale is intended to measure how children feel inside, not how their face looks. Brief word instructions: Point to each face using the words to describe the pain intensity. Ask the children to choose a face that best describes their pain and record the appropriate number.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion24 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagah ABdelrahman, Mohammed Bin Rashid University of Medicine and Health Sciences
- Investigators
- Nagah Abdelrahman, Principal investigator, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011005
- Sponsor's protocol ID
- MBRU IRB-2022-174
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dasarraju RK, Svsg N. Comparative efficacy of three topical anesthetics on 7-11-year-old children: a randomized clinical study. J Dent Anesth Pain Med. 2020 Feb;20(1):29-37. doi: 10.17245/jdapm.2020.20.1.29. Epub 2020 Feb 28.
PubMed 32158957Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.
PubMed 34934271Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.
PubMed 11242725Gill CJ, Orr DL 2nd. A double-blind crossover comparison of topical anesthetics. J Am Dent Assoc. 1979 Feb;98(2):213-4. doi: 10.14219/jada.archive.1979.0476.
PubMed 370178Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
PubMed 26379379Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
PubMed 31842771Hersh EV, Houpt MI, Cooper SA, Feldman RS, Wolff MS, Levin LM. Analgesic efficacy and safety of an intraoral lidocaine patch. J Am Dent Assoc. 1996 Nov;127(11):1626-34; quiz 1665-6. doi: 10.14219/jada.archive.1996.0098.
PubMed 8952239Amado A, Sood A, Taylor JS. Contact allergy to lidocaine: a report of sixteen cases. Dermatitis. 2007 Dec;18(4):215-20. doi: 10.2310/6620.2007.06059.
PubMed 18021602Silver K, Silver J. The place of James Arnott (1797-1883) in the development of local anaesthesia in dentistry. Br Dent J. 2016 Mar 11;220(5):249-52. doi: 10.1038/sj.bdj.2016.179.
PubMed 26964600Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
PubMed 26957683Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
PubMed 8169463Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.
PubMed 25526231Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.
PubMed 19119169DiMarco AC, Wetmore AO. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.
PubMed 27269661
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06011005
- Acronym / sponsor ID
- MBRU IRB-2022-174
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 24 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Aug 2023 (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 single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
The main question[s] it aims to answer are:
- How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%?
Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.
Detailed description
Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group A) Ethyl Chloride (EC) | Experimental | Other: Ethyl Chloride spray (group A)Topical application for 30 sec. |
| (Group B) Benzocaine gel 20% (BC) | Active comparator | Other: Benzocaine gel 20% (group B)BC 20% Topical gel application for 30 sec and left for 1 minute. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children (ASA I) aged between 7 - 10 years old.
- Needing any maxillary buccal infiltration (anterior, middle, posterior)
- Had no prior history of local anesthesia.
- Frankl behavior III or IV
- Not taking any painkillers, or other drugs that would influence with their pain perception.
Key exclusion criteria (6 listed)
- History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
- Active pathology at the site of injection.
- Prior history of intra-oral injection.
- Frankl behavior I or II.
- Children/parents not willing to participate in the study. § Needle phobia.
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 Chloride spray (group A)Cold test spray | Other | (Group A) Ethyl Chloride (EC) |
| Benzocaine gel 20% (group B)Topical analgesia | Other | (Group B) Benzocaine gel 20% (BC) |
Primary outcome
Heart rate
Time frame: 5-10 minutes
Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.
3 secondary outcomes
Sound, Eye, Motor (SEM) Index
Time frame: 5-10 minutes
Visual Analog Scale (VAS)
Time frame: 5-10 minutes
Face Pain Scale
Time frame: 5-10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Results publication: PubMed 32158957Dasarraju RK, Svsg N. Comparative efficacy of three topical anesthetics on 7-11-year-old children: a randomized clinical study. J Dent Anesth Pain Med. 2020 Feb;20(1):29-37. doi: 10.17245/jdapm.2020.20.1.29. Epub 2020 Feb 28.
- Results publication: PubMed 34934271Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.
- Results publication: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Results publication: PubMed 11242725Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.
- Results publication: PubMed 370178Gill CJ, Orr DL 2nd. A double-blind crossover comparison of topical anesthetics. J Am Dent Assoc. 1979 Feb;98(2):213-4. doi: 10.14219/jada.archive.1979.0476.
- Results publication: PubMed 26379379Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
- Results publication: PubMed 31842771Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
- Results publication: PubMed 8952239Hersh EV, Houpt MI, Cooper SA, Feldman RS, Wolff MS, Levin LM. Analgesic efficacy and safety of an intraoral lidocaine patch. J Am Dent Assoc. 1996 Nov;127(11):1626-34; quiz 1665-6. doi: 10.14219/jada.archive.1996.0098.
- Results publication: PubMed 18021602Amado A, Sood A, Taylor JS. Contact allergy to lidocaine: a report of sixteen cases. Dermatitis. 2007 Dec;18(4):215-20. doi: 10.2310/6620.2007.06059.
- Results publication: PubMed 26964600Silver K, Silver J. The place of James Arnott (1797-1883) in the development of local anaesthesia in dentistry. Br Dent J. 2016 Mar 11;220(5):249-52. doi: 10.1038/sj.bdj.2016.179.
- Results publication: PubMed 26957683Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
- Results publication: PubMed 8169463Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
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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.
Nagah Abdelrahman 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 study testing Ethyl Chloride spray (group A) and Benzocaine gel 20% (group B) in people with Dental Caries in Children and Anesthesia, Local, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagah Abdelrahman (971551225599, Nagah.abdelrahman@residents.mbru.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 5-10 minutes). 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 NCT06011005, which also lists 21 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 25 Aug 2023.