Extrusion of ToothNCT05187494
Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children
A study testing Conventional local palatine injection, EMLA cream only and chemical permeability enhancer DMSO with EMLA cream in people with Extrusion of Tooth, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Extrusion of Tooth
- What is being tested?
- Conventional local palatine injection, EMLA cream only and chemical permeability enhancer DMSO with EMLA cream
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSyria
- Study dates
- 20 May 2021to 27 Sep 2021
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no previous dental experience.
- Healthy children.
- Definitely positive or positive ratings of Frank scale
- Child did not receive any sedative or pain drugs during the last three.
- Presence of upper primary teeth, an indication for extraction
Who cannot join
- Presence of general diseases or health problems.
- Uncooperative children
- Children with congenital or idiopathic Methemoglobin
- Teeth with severe abscesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Role of Some Drug Delivery Systems in Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children Aged Between 7-11 Years Old
The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.
Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only. Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.
Read the detailed description
The insertion of the needle and the infusion of the anesthetic solution into the palate often uncomfortable for the children and their acceptance of dental treatment. Therefore, there is a need for studies to find ways to replace the palatine injection in the modern dentistry.
Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be enhanced by one of the drug delivery systems (physical/chemical).
Decreased permeability of the palatine mucosa is a major reason behind using drug delivery systems to reach an effective therapeutic level.
To our knowledge, this research will be the first which will be used a method of drug delivery systems to replace traditional palatal needle.
- Conditions
- Extrusion of Tooth
- Being tested
- Conventional local palatine injection, EMLA cream only, chemical permeability enhancer DMSO with EMLA cream, Oral patches with EMLA Cream, Micro-needle patches dissolved with EMLA Cream
- Keywords
- EMLA, Micro-needle patches, Permeability enhancer, Oral patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional local palatine injectionOther
Conventional palatal injection with anesthetic (lidocaine HCL2% with Epinephrine 1:80000, Korea) Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness
EMLA cream onlyDrug
Emla cream will be applied at a distance of 1 mm from the palatine gingival edge by cotton buds for 3 minutes within the application area 14*14 mm and the mouth will be open throughout the procedure and the saliva will be controlled by a saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.
chemical permeability enhancer DMSO with EMLA creamDrug
Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes while the child is opening his mouth and the saliva is controlled by saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.
Oral patches with EMLA CreamDrug
EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an oral patch 14*14 mm for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness
Micro-needle patches dissolved with EMLA CreamDrug
EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| Conventional local palatine injection | Other | Conventional palatal injection with anesthetic (lidocaine 2% with Epinephrine 1:80000, Korea) will be performed and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. Receives: Other: Conventional local palatine injection |
| EMLA cream only | Experimental | The palatine mucosa will be dried with a cotton ball 2*2 and then 0,2 g of Emla cream will be applied for 3 minutes . During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. Receives: Drug: EMLA cream only |
| chemical permeability enhancer DMSO with EMLA cream | Experimental | The palatine mucosa will be dried with a cotton ball and then EMLA cream will be mixed with a permeability enhancer in the laboratory of pharmaceutical industries at the Faculty of Pharmacy at Damascus University according to the following: Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. Receives: Drug: chemical permeability enhancer DMSO with EMLA cream |
| Oral patches with EMLA Cream | Experimental | The palatine mucosa will be dried with a cotton ball and then 0.2 g of EMLA cream 5% will be applied by using an oral patch 14*14 mm for 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. Receives: Drug: Oral patches with EMLA Cream |
| Micro-needle patches dissolved with EMLA Cream | Experimental | The palatine mucosa will be dried with a cotton ball 2*2 and then 0.2 g of EMLA cream 5% will be applied by using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes. Receives: Drug: Micro-needle patches dissolved with EMLA Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the values of each of the heart rate and oxygen rate
The heart and oxygen rate will be recorded by pulse oximeter
Measured: On application of the substance
Evaluation conventional local palatine injection
The heart and oxygen rate will be recorded by pulse oximeter
Measured: On palatal probing
Evaluation conventional local palatine injection
The heart and oxygen rate will be recorded by pulse oximeter
Measured: On extraction
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Measured: On application of the substance
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Measured: On palatal probing
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Measured: On extraction
Pain levels using FLACC scale
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Measured: On application of the substance
Pain levels using FLACC scale
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Measured: On palatal probing
Pain levels using FLACC scale
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Measured: On extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 May 2021
- Primary completion23 Aug 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extrusion of ToothStudies 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
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farah M Babakurd, DDS, Principal investigator, MSc student in Pedodontics, University of DamascusShadi K Azzawi, Phd, Study director, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187494
- Sponsor's protocol ID
- UDDS-Pedo-05-2021
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munshi AK, Hegde AM, Latha R. Use of EMLA: is it an injection free alternative? J Clin Pediatr Dent. 2001 Spring;25(3):215-9. doi: 10.17796/jcpd.25.3.hn62713500418728.
PubMed 12049081Davidovich E, Wated A, Shapira J, Ram D. The influence of location of local anesthesia and complexity/duration of restorative treatment on children's behavior during dental treatment. Pediatr Dent. 2013 Jul-Aug;35(4):333-6.
PubMed 23930632Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.
PubMed 12762609Franz-Montan M, Ribeiro LNM, Volpato MC, Cereda CMS, Groppo FC, Tofoli GR, de Araujo DR, Santi P, Padula C, de Paula E. Recent advances and perspectives in topical oral anesthesia. Expert Opin Drug Deliv. 2017 May;14(5):673-684. doi: 10.1080/17425247.2016.1227784. Epub 2016 Sep 1.
PubMed 27554455Shaikh R, Raj Singh TR, Garland MJ, Woolfson AD, Donnelly RF. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011 Jan;3(1):89-100. doi: 10.4103/0975-7406.76478.
PubMed 21430958
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Role of Some Drug Delivery Systems in Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children Aged Between 7-11 Years Old
- ClinicalTrials.gov ID
- NCT05187494
- Acronym / sponsor ID
- UDDS-Pedo-05-2021
- Conditions
- Extrusion of Tooth
- Keywords
- EMLA, Micro-needle patches, Permeability enhancer, Oral patches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 11 Jan 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.
The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.
Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only. Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.
Detailed description
The insertion of the needle and the infusion of the anesthetic solution into the palate often uncomfortable for the children and their acceptance of dental treatment. Therefore, there is a need for studies to find ways to replace the palatine injection in the modern dentistry.
Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be enhanced by one of the drug delivery systems (physical/chemical).
Decreased permeability of the palatine mucosa is a major reason behind using drug delivery systems to reach an effective therapeutic level.
To our knowledge, this research will be the first which will be used a method of drug delivery systems to replace traditional palatal needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Conventional local palatine injection | Other | Other: Conventional local palatine injectionConventional palatal injection with anesthetic (lidocaine 2% with Epinephrine 1:80000, Korea) will be performed and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. |
| EMLA cream only | Experimental | Drug: EMLA cream onlyThe palatine mucosa will be dried with a cotton ball 2*2 and then 0,2 g of Emla cream will be applied for 3 minutes . During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. |
| chemical permeability enhancer DMSO with EMLA cream | Experimental | Drug: chemical permeability enhancer DMSO with EMLA creamThe palatine mucosa will be dried with a cotton ball and then EMLA cream will be mixed with a permeability enhancer in the laboratory of pharmaceutical industries at the Faculty of Pharmacy at Damascus University according to the following: Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. |
| Oral patches with EMLA Cream | Experimental | Drug: Oral patches with EMLA CreamThe palatine mucosa will be dried with a cotton ball and then 0.2 g of EMLA cream 5% will be applied by using an oral patch 14*14 mm for 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child. |
| Micro-needle patches dissolved with EMLA Cream | Experimental | Drug: Micro-needle patches dissolved with EMLA CreamThe palatine mucosa will be dried with a cotton ball 2*2 and then 0.2 g of EMLA cream 5% will be applied by using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- no previous dental experience.
- Healthy children.
- Definitely positive or positive ratings of Frank scale
- Child did not receive any sedative or pain drugs during the last three.
- Presence of upper primary teeth, an indication for extraction
Key exclusion criteria (4 listed)
- Presence of general diseases or health problems.
- Uncooperative children
- Children with congenital or idiopathic Methemoglobin
- Teeth with severe abscesses
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 |
|---|---|---|
| Conventional local palatine injectionConventional palatal injection with anesthetic (lidocaine HCL2% with Epinephrine 1:80000, Korea) Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness | Other | Conventional local palatine injection |
| EMLA cream onlyEmla cream will be applied at a distance of 1 mm from the palatine gingival edge by cotton buds for 3 minutes within the application area 14*14 mm and the mouth will be open throughout the procedure and the saliva will be controlled by a saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness. | Drug | EMLA cream only |
| chemical permeability enhancer DMSO with EMLA creamAdding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes while the child is opening his mouth and the saliva is controlled by saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness. | Drug | chemical permeability enhancer DMSO with EMLA cream |
| Oral patches with EMLA CreamEMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an oral patch 14*14 mm for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness | Drug | Oral patches with EMLA Cream |
| Micro-needle patches dissolved with EMLA CreamEMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness. | Drug | Micro-needle patches dissolved with EMLA Cream |
Primary outcome
Changes in the values of each of the heart rate and oxygen rate
Time frame: On application of the substance
The heart and oxygen rate will be recorded by pulse oximeter
Evaluation conventional local palatine injection
Time frame: On palatal probing
The heart and oxygen rate will be recorded by pulse oximeter
Evaluation conventional local palatine injection
Time frame: On extraction
The heart and oxygen rate will be recorded by pulse oximeter
Pain levels using self-reported Wong-Baker faces pain scale
Time frame: On application of the substance
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Pain levels using self-reported Wong-Baker faces pain scale
Time frame: On palatal probing
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Pain levels using self-reported Wong-Baker faces pain scale
Time frame: On extraction
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Pain levels using FLACC scale
Time frame: On application of the substance
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Pain levels using FLACC scale
Time frame: On palatal probing
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Pain levels using FLACC scale
Time frame: On extraction
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/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 11 Jan 2022.
- Background: PubMed 12049081Munshi AK, Hegde AM, Latha R. Use of EMLA: is it an injection free alternative? J Clin Pediatr Dent. 2001 Spring;25(3):215-9. doi: 10.17796/jcpd.25.3.hn62713500418728.
- Background: PubMed 23930632Davidovich E, Wated A, Shapira J, Ram D. The influence of location of local anesthesia and complexity/duration of restorative treatment on children's behavior during dental treatment. Pediatr Dent. 2013 Jul-Aug;35(4):333-6.
- Background: PubMed 12762609Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.
- Background: PubMed 27554455Franz-Montan M, Ribeiro LNM, Volpato MC, Cereda CMS, Groppo FC, Tofoli GR, de Araujo DR, Santi P, Padula C, de Paula E. Recent advances and perspectives in topical oral anesthesia. Expert Opin Drug Deliv. 2017 May;14(5):673-684. doi: 10.1080/17425247.2016.1227784. Epub 2016 Sep 1.
- Background: PubMed 21430958Shaikh R, Raj Singh TR, Garland MJ, Woolfson AD, Donnelly RF. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011 Jan;3(1):89-100. doi: 10.4103/0975-7406.76478.
- 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.
Farah M Babakurd, DDS principal investigator
MSc student in Pedodontics, University of Damascus
Shadi K Azzawi, Phd study director
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional local palatine injection, EMLA cream only and chemical permeability enhancer DMSO with EMLA cream in people with Extrusion of Tooth, run by Damascus University at 1 site in Syria.
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 4 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 11 Jan 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 Syria. 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?
Changes in the values of each of the heart rate and oxygen rate (time frame: On application of the substance). The study lists 9 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 NCT05187494, which also lists 5 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 11 Jan 2022.