Molar Incisor HypomineralisationPhase 1/2NCT05585112
Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars
A Phase 1/2 study testing Lidocaine 2% and Articaine 4% in people with Molar Incisor Hypomineralisation, run by Latakia University at 1 site in Syria.
Trial summary
Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars. Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralisation
- What is being tested?
- Lidocaine 2% and Articaine 4%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSyria
- Study dates
- 17 Oct 2022to 25 Dec 2022
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Absolute positive or positive behavior according to the Frankel Scale.
- child is not under the effect of any analgesics or sedatives and their weight was more than 20 kg.
- Healthy, both physically and mentally
- A child with a MIH-affected maxillary permanent first molar on the right and left sides .
Who cannot join
- children who are uncooperative
- allergic anesthetics used in the study
- children who show inflammation in the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Articaine 4% Versus Lidocaine 2% in Local Anesthesia and Permanent Maxillary First Molars Affected by MIH.
Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars.
Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old
Read the detailed description
Background and Aims: Some dentists have difficulty obtaining effective anesthesia when treating MIH molars.
There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary molars.
Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children , aged 6-12 years old. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the second solution being used at the second session.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- Lidocaine 2%, Articaine 4%
- Keywords
- local anesthesia, Lidocaine 2%, Articaine 4%, molars
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2%Drug
Also called A
The child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale
Articaine 4%Drug
Also called B
The child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale
| Study group | Role | What they receive |
|---|---|---|
| A (Lidocaine 2%) | Active comparator | 26 children will be injected with 1 ml of lidocaine 2% with epinephrine Receives: Drug: Lidocaine 2% |
| B (Articaine 4%) | Experimental | 26 children will be injected with 1 ml of Articaine 4% with epinephrine. Receives: Drug: Articaine 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection pain
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..
Measured: during the injection of local anesthesia procedure
injection pain
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
Measured: Immediately after the injection of local anesthesia procedure
dental pain
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..
Measured: during procedure
dental pain
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
Measured: Immediately after treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start17 Oct 2022
- Primary completion5 Dec 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies 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
- Crossover
- Model description
- A randomized, controlled, crossover, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabih Raslan, Dr, Study chair, Latakia UniversityMai Haidar, Dr, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585112
- Sponsor's protocol ID
- Tishreen U _Local anesthesia
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Articaine 4% Versus Lidocaine 2% in Local Anesthesia and Permanent Maxillary First Molars Affected by MIH.
- ClinicalTrials.gov ID
- NCT05585112
- Acronym / sponsor ID
- Tishreen U _Local anesthesia
- Conditions
- Molar Incisor Hypomineralisation
- Keywords
- local anesthesia, Lidocaine 2%, Articaine 4%, molars
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 18 Oct 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.
Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars.
Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old
Detailed description
Background and Aims: Some dentists have difficulty obtaining effective anesthesia when treating MIH molars.
There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary molars.
Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children , aged 6-12 years old. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the second solution being used at the second session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled, crossover, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%
| Arm | Type | Receives |
|---|---|---|
| A (Lidocaine 2%) | Active comparator | Drug: Lidocaine 2%26 children will be injected with 1 ml of lidocaine 2% with epinephrine |
| B (Articaine 4%) | Experimental | Drug: Articaine 4%26 children will be injected with 1 ml of Articaine 4% with epinephrine. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Absolute positive or positive behavior according to the Frankel Scale.
- child is not under the effect of any analgesics or sedatives and their weight was more than 20 kg.
- Healthy, both physically and mentally
- A child with a MIH-affected maxillary permanent first molar on the right and left sides .
Key exclusion criteria (3 listed)
- children who are uncooperative
- allergic anesthetics used in the study
- children who show inflammation in the injection site.
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 |
|---|---|---|
| Lidocaine 2%Also: AThe child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale | Drug | A (Lidocaine 2%) |
| Articaine 4%Also: BThe child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale | Drug | B (Articaine 4%) |
Primary outcome
injection pain
Time frame: during the injection of local anesthesia procedure
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..
injection pain
Time frame: Immediately after the injection of local anesthesia procedure
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
dental pain
Time frame: during procedure
evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain)..
dental pain
Time frame: Immediately after treatment procedure
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
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 3 May 2023.
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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.
Nabih Raslan, Dr study chair
Latakia University
Mai Haidar, Dr principal investigator
Latakia 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 Lidocaine 2% and Articaine 4% in people with Molar Incisor Hypomineralisation, run by Latakia 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 4 inclusion and 3 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 3 May 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 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.
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?
injection pain (time frame: during the injection of local anesthesia procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.