Molar Incisor HypomineralisationPhase 1/2NCT05200884
Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
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
Aims: Comparison of injection pain with lidocaine and articaine in children with MIH . Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars. Design: A randomized, controlled, crossover, double-blind clinical study including twenty 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
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 22 Jan 2022to 10 Jun 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.
- Healthy, both physically and mentally.
- Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- A child with a MIH-affected mandibular permanent first molar on the right and left sides .
Who cannot join
- Teeth with non-response pulpitis Inflammation at the injection site.
- Allergy to the substances used in anesthesia.
- Presence of general or developmental medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)
Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .
Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.
Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old
Read the detailed description
Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their first or second visit.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- Lidocaine 2%, Articaine 4%
- Keywords
- the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH 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% and After 10 minutes 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 and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face scale
| Study group | Role | What they receive |
|---|---|---|
| : A (Lidocaine 2%) | Active comparator | 20 children will be injected with 1 ml of lidocaine 2% with epinephrine. each one received lidocaine2% at his\her first or second visit.
Half of the total number of injections for 20 children i.e. 20 injections will be distributed randomly to the two drugs using the randomization table Receives: Drug: Lidocaine 2% |
| B (Articaine 4%) | Experimental | 20 children will be injected with 1 ml of Articaine 4% with epinephrine. each one received articaine 4% at his\her first or second visit.
Half of the total number of injections for 20 children i.e.20 injections will be distributed randomly to the two drugs using the randomization table Receives: Drug: Articaine 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the injection of local anesthesia
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 the injection of local anesthesia
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 treatment
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 the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start22 Jan 2022
- Primary completion25 Mar 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT05200884
- Sponsor's protocol ID
- Tishreen U _pediatricDentistry
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: up to date, there is no decision about IPD sharing.
Publications
Haidar M, Raslan N. Comparative study of articaine 4% versus lidocaine 2% in the local anesthesia of permanent mandibular first molars affected by MIH: a randomized controlled trial. Eur Arch Paediatr Dent. 2023 Oct;24(5):621-630. doi: 10.1007/s40368-023-00827-w. Epub 2023 Aug 1.
PubMed 37526883
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)
- ClinicalTrials.gov ID
- NCT05200884
- Acronym / sponsor ID
- Tishreen U _pediatricDentistry
- Conditions
- Molar Incisor Hypomineralisation
- Keywords
- the local anesthesia, Lidocaine 2%, Articaine 4%, children, MIH molars.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 21 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.
Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .
Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.
Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old
Detailed description
Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their first or second visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
| Arm | Type | Receives |
|---|---|---|
| : A (Lidocaine 2%) | Active comparator | Drug: Lidocaine 2%20 children will be injected with 1 ml of lidocaine 2% with epinephrine. each one received lidocaine2% at his\her first or second visit. Half of the total number of injections for 20 children i.e. 20 injections will be distributed randomly to the two drugs using the randomization table |
| B (Articaine 4%) | Experimental | Drug: Articaine 4%20 children will be injected with 1 ml of Articaine 4% with epinephrine. each one received articaine 4% at his\her first or second visit. Half of the total number of injections for 20 children i.e.20 injections will be distributed randomly to the two drugs using the randomization table |
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.
- Healthy, both physically and mentally.
- Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- A child with a MIH-affected mandibular permanent first molar on the right and left sides .
Key exclusion criteria (3 listed)
- Teeth with non-response pulpitis Inflammation at the injection site.
- Allergy to the substances used in anesthesia.
- Presence of general or developmental medical conditions.
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% and After 10 minutes 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 and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face scale | Drug | B (Articaine 4%) |
Primary outcome
dental pain
Time frame: during the injection of local anesthesia
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 the injection of local anesthesia
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 treatment
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 the treatment
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 15 Jul 2022.
- Derived from this study: PubMed 37526883Haidar M, Raslan N. Comparative study of articaine 4% versus lidocaine 2% in the local anesthesia of permanent mandibular first molars affected by MIH: a randomized controlled trial. Eur Arch Paediatr Dent. 2023 Oct;24(5):621-630. doi: 10.1007/s40368-023-00827-w. Epub 2023 Aug 1.
- Individual participant dataSharing planned: Undecided. up to date, there is no decision about IPD sharing.
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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 15 Jul 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.
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?
dental pain (time frame: during the injection of local anesthesia). 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?
On the ClinicalTrials.gov record for NCT05200884, which also lists 1 linked publication.
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 15 Jul 2022.