Anesthesia, DentalPhase 1/2NCT04317508
Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection
A Phase 1/2 study testing Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% in people with Anesthesia, Dental, run by Dina Youssef Attia at 1 site in Egypt.
Trial summary
Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Anesthesia, Dental
- What is being tested?
- Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 19 Feb 2020
- Phase
- Phase 1/2
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ranging in age from 6 to 8 years.
- Healthy children with no contraindications of use of local anesthetics.
- Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
- Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.
Who cannot join
- Uncooperative children or with intellectual or physical disabilities or medical conditions.
- Children with acute pain or emergency visits.
- Children with previous negative dental experience.
- Children receiving premedications or analgesics 48 hours before testing.
- children/parents not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial
Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.
Read the detailed description
A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.
A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).
- Conditions
- Anesthesia, Dental
- Being tested
- Topicale GelPatch (Benzocaine 18%), Benzocaine oral gel 20%
- Keywords
- benzocaine, Topical, oral patch, pain, dental anesthesia, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topicale GelPatch (Benzocaine 18%)Drug
Intervention group
Benzocaine oral gel 20%Drug
control group
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Topicale® topical anesthetic gel patch (Benzocaine 18%) Receives: Drug: Topicale GelPatch (Benzocaine 18%) |
| control group | Placebo comparator | Opahl® topical anesthetic gel (Benzocaine 20%) Receives: Drug: Benzocaine oral gel 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection
The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale
Sound, Eye, Motor scale:
Grade 1: Comfort
- Sound: No sound
- Eye: No signs
- Motor: Relaxed body and hand
Grade 2: Mild discomfort
- Sound: Non specific sound
- Eye: Dilated without tears
- Motor: Muscular contractions of hand
Grade 3: Moderate discomfort
- Sound: Verbal compliant, louder sound
- Eye: Tears, sudden eye movement
- Motor: Sudden body and hand movements
Grade 4: Severe discomfort
- Sound: Verbal compliant shouting, crying
- Eye: Crying, tears all over face
- Motor: Hand movement for defense, Turning the head to opposite side
Measured: 4 months
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R).
2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain".
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Nov 2019
- Primary completion13 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, DentalStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Youssef Attia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Youssef Attia, Alexandria University
- Investigators
- Huda M Ibrahim, BSc, Principal investigator, Alexandria UniversityAmina Abdelrahman, PhD, Study director, Alexandria UniversityAly Sharaf, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317508
- Sponsor's protocol ID
- Benzocaine gel patch
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12.
PubMed 18341564Stecker SS, Swift JQ, Hodges JS, Erickson PR. Should a mucoadhesive patch (DentiPatch) be used for gingival anesthesia in children? Anesth Prog. 2002 Winter;49(1):3-8.
PubMed 12779107
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04317508
- Acronym / sponsor ID
- Benzocaine gel patch
- Conditions
- Anesthesia, Dental
- Keywords
- benzocaine, Topical, oral patch, pain, dental anesthesia, children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dina Youssef AttiaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 23 Mar 2020 (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 anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.
Detailed description
A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.
A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Topicale GelPatch (Benzocaine 18%)Topicale® topical anesthetic gel patch (Benzocaine 18%) |
| control group | Placebo comparator | Drug: Benzocaine oral gel 20%Opahl® topical anesthetic gel (Benzocaine 20%) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ranging in age from 6 to 8 years.
- Healthy children with no contraindications of use of local anesthetics.
- Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
- Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.
Key exclusion criteria (5 listed)
- Uncooperative children or with intellectual or physical disabilities or medical conditions.
- Children with acute pain or emergency visits.
- Children with previous negative dental experience.
- Children receiving premedications or analgesics 48 hours before testing.
- children/parents not willing to participate.
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 |
|---|---|---|
| Topicale GelPatch (Benzocaine 18%)Intervention group | Drug | Intervention group |
| Benzocaine oral gel 20%control group | Drug | control group |
Primary outcome
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection
Time frame: 4 months
The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale Sound, Eye, Motor scale: Grade 1: Comfort * Sound: No sound * Eye: No signs * Motor: Relaxed body and hand Grade 2: Mild discomfort * Sound: Non specific sound * Eye: Dilated without tears * Motor: Muscular contractions of hand Grade 3: Moderate discomfort * Sound: Verbal compliant, louder sound * Eye: Tears, sudden eye movement * Motor: Sudden body and hand movements Grade 4: Severe discomfort * Sound: Verbal compliant shouting, crying * Eye: Crying, tears all over face * Motor: Hand movement for defense, Turning the head to opposite side
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection
Time frame: 4 months
Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R). 2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain".
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 23 Mar 2020.
- Results publication: PubMed 18341564Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12.
- Results publication: PubMed 12779107Stecker SS, Swift JQ, Hodges JS, Erickson PR. Should a mucoadhesive patch (DentiPatch) be used for gingival anesthesia in children? Anesth Prog. 2002 Winter;49(1):3-8.
- 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.
Huda M Ibrahim, BSc principal investigator
Alexandria University
Amina Abdelrahman, PhD study director
Alexandria University
Aly Sharaf, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% in people with Anesthesia, Dental, run by Dina Youssef Attia at 1 site in Egypt.
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 4 inclusion and 5 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 23 Mar 2020. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT04317508, which also lists 2 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 23 Mar 2020.