Dental Caries in ChildrenPhase 3NCT05839548
Articaine Efficacy and Safety for 3 Years Old Children
A Phase 3 study testing Mepivacaine 2% with epinephrine 1:100,000 and Articaine (4%) with epinephrine 1:100,000 in people with Dental Caries in Children and Dental Diseases, run by Qassim Health Cluster at 1 site in Saudi Arabia.
Trial summary
The primary purpose of this study is to determine the local anesthetic efficacy and safety of 4% Articaine compared 2% Mepivicaine in 3 years old children, by using infiltration technique for primary teeth that required restorative, pulp therapy, or dental extraction procedure, as assessed by measuring the pain… Read more about this study
- Who is it for?
- Ages 36 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Dental Diseases, Pulp Disease, Dental
- What is being tested?
- Mepivacaine 2% with epinephrine 1:100,000 and Articaine (4%) with epinephrine 1:100,000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2023to 31 May 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 36 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients have to meet all of the following inclusion criteria. They are eligible if:
- 1. They are Healthy (ASA 1: no acute or chronic disease, normal BMI percentile for age.
- They are 36 to 47 months old children.
- Intellectually qualified for communication.
- They have under gone either clinically indicated gingival abscess, dental caries or pathological root resorption or periapical radiolucency showing on the radiograph.
- Child's body weight at least 15 kg.
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- Ability to communicate effectively in the Arabic or English language.
- Not taking any agents likely to interfere with reporting of pain (analgesics).
- Needs any of the following procedure: Class I cavity, Class II cavity, pulpotomy, pulpectomy, stainless steel crown (SSC) or extraction.
- Prior to enrollment, all radiographic data must be found acceptable by pediatric dentist.
- Written and singed informed consent from legally acceptable representative.
Who cannot join
- Patients are excluded from the study if:
- Patients have allergic to local anesthetic with epinephrine (sulphites or amide).
- Intellectual or severe emotional problems. patient with intellectual development is significantly lower than average and his or her ability to adapt to the environment is consequently limited like autism, Down syndrome, fragile x syndrome, fetal alcohol syndrome, and Prader-Willi syndrome.
- Considerable behavior problems.
- Parents refuse participation in the trial.
- History of previous bad dental experience.
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- Primary tooth who had a history of failed pulp therapy.
- They have uncontrolled medical condition.
- They use immunosuppressive agents, rifampin, or anticonvulsants, or any other medication.
- Glucose 6 phosphate dehydrogenase deficiency.
- Congenital cardiac diseases.
- Seizures or uncontrolled epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Articaine Efficacy and Safety for 3 Years Old Children: a Clinical Randomized Control Trial
The primary purpose of this study is to determine the local anesthetic efficacy and safety of 4% Articaine compared 2% Mepivicaine in 3 years old children, by using infiltration technique for primary teeth that required restorative, pulp therapy, or dental extraction procedure, as assessed by measuring the pain experience during injection and treatment procedures, child's behavior during the procedure, and postoperative complications.
Read the detailed description
Articaine has been widely used in dental surgery. Dentists started to use carticaine around 1977. In dentistry, articaine has been investigated extensively. Clinical trials comparing articaine mostly with lidocaine have varied in study design and site of action. The overwhelming majority of references in the literature describing the alleged neurotoxicity of articain concern paraesthesia and prolonged numbness after dental procedures. An excellent review of the dental literature was published last year. The authors concluded that articaine is a safe and effective local anesthetic drug to use in all aspects of clinical dentistry for patients of all ages, with properties comparable to other common local anesthetic agents. Although there may be controversy regarding its safety and advantages in comparison to other local anesthetics, there is no conclusive evidence demonstrating neurotoxicity or significantly superior anesthetic properties of articaine for dental procedures. The choice whether to use articaine or another local anesthetic is based on the personal preference and experiences of individual clinicians. 3Currently, articaine is available as a 4% solution containing 1:100,000 or 1:200,000 epinephrine. Clinical trials comparing 4% with 2% solutions show no clinical advantage of 4% over a 2% solution.
- Being tested
- Mepivacaine 2% with epinephrine 1:100,000, Articaine (4%) with epinephrine 1:100,000
- Keywords
- Articaine., Local anaesthesia., Child., Pain.
- Medical subject headings
- Stomatognathic Diseases, Dental Pulp Diseases, Child Behavior, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepivacaine 2% with epinephrine 1:100,000Drug
Also called medicaine 2%
Local Anesthesia
Articaine (4%) with epinephrine 1:100,000Drug
Also called septanest 4%
Local Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 2% Mepivacaine with epinephrine 1:100,000. | Active comparator | Brand Name: 2% Medicaine with epinephrine 1:100,000. Receives: Drug: Mepivacaine 2% with epinephrine 1:100,000 |
| 4% Articaine with epinephrine 1:100,000 | Experimental | Brand Name: 4% Septanest with epinephrine 1:100,000. Receives: Drug: Articaine (4%) with epinephrine 1:100,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure (mmHg).
Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.
Measured: 5 minutes before, during, and after 30 minutes of dental procedure.
Change in pulse rate (beats per minute).
Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Measured: 5 minutes before, during, and after 30 minutes of dental procedure.
Change in respiratory rate (breaths per minute).
The respiration rate is the number of breaths a person takes per minute.
Measured: 5 minutes before, during, and after 30 minutes of dental procedure.
Dental pain assessment: Frankl Behavior Rating Scale (FBRS).
Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
Measured: up to 30 minutes after dental procedure.
Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC).
Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: relaxed and comfortable,1-3: mild discomfort, 4-6: moderate discomfort, 7-10: sever discomfort or pain or both.
Measured: up to 30 minutes after dental procedure.
Secondary outcomes (1)
Post-operative complications.
asking the parent in next 24 hours from dental procedure, by using parents' post operative pain measure (PPPM). It will be dichotomized into absent (0-5) and present (6-15).
Measured: 24 hours after dental procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jul 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, clinical trial with two parallel arms, to evaluate the safety and efficacy of 4% Articaine, 2% Mepivacaine on vital and non-vital primary teeth that needs restorative, pulp therapy, or dental extraction by using buccal infiltration technique. The effect will be assessed by measuring the pain experience during injection and treatment procedures, and by assessing the child's behavior during the procedure, and postoperative pain and complications. The study consisted of a screening period for up to 6 months. A Qualified participants through the screening assessments will be assigned randomly to receive either 4% Articaine, or 2% Mepivacaine.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim Health Cluster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Murad A. Alrashdi, ABPD, Study chair, Qassim UniversityAsya A. Almansour, SBPD, Principal investigator, Ministry of Health, Qassim cluster.Atyaf A. Alhunti, Study director, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839548
- Sponsor's protocol ID
- 607\43\7809
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elheeny AAH. Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial. Int J Paediatr Dent. 2020 Sep;30(5):547-555. doi: 10.1111/ipd.12640. Epub 2020 Apr 13.
PubMed 32223002Brignardello-Petersen R. Articaine and lidocaine probably have similar effects in 3- to 4-year-old children undergoing pulpotomy of a primary molar. J Am Dent Assoc. 2020 Oct;151(10):e93. doi: 10.1016/j.adaj.2020.06.029. Epub 2020 Aug 11. No abstract available.
PubMed 32797942Massignan C, Silveira Santos P, Cardoso M, Bolan M. Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. J Oral Rehabil. 2020 Aug;47(8):1031-1040. doi: 10.1111/joor.12989. Epub 2020 May 25.
PubMed 32383196Rayati F, Haeri M, Norouziha A, Jabbarian R. Comparison of the efficacy of 4% articaine with epinephrine 1:100,000 and 2% lidocaine with epinephrine 1:100,000 buccal infiltration for single maxillary molar extraction: a double-blind, randomised, clinical trial. Br J Oral Maxillofac Surg. 2021 Jul;59(6):695-699. doi: 10.1016/j.bjoms.2020.09.009. Epub 2020 Sep 11.
PubMed 34053801Alrashdi M, Alhunti A, Almansour A. Efficacy and safety of articaine in 3-year-old children for dental procedures: a protocol for a clinical randomised control trial in Saudi Arabia. BMJ Open. 2023 Oct 21;13(10):e077751. doi: 10.1136/bmjopen-2023-077751.
PubMed 37865418
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine Efficacy and Safety for 3 Years Old Children: a Clinical Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05839548
- Acronym / sponsor ID
- 607\43\7809
- Keywords
- Articaine., Local anaesthesia., Child., Pain.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qassim Health ClusterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 May 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 primary purpose of this study is to determine the local anesthetic efficacy and safety of 4% Articaine compared 2% Mepivicaine in 3 years old children, by using infiltration technique for primary teeth that required restorative, pulp therapy, or dental extraction procedure, as assessed by measuring the pain experience during injection and treatment procedures, child's behavior during the procedure, and postoperative complications.
Detailed description
Articaine has been widely used in dental surgery. Dentists started to use carticaine around 1977. In dentistry, articaine has been investigated extensively. Clinical trials comparing articaine mostly with lidocaine have varied in study design and site of action. The overwhelming majority of references in the literature describing the alleged neurotoxicity of articain concern paraesthesia and prolonged numbness after dental procedures. An excellent review of the dental literature was published last year. The authors concluded that articaine is a safe and effective local anesthetic drug to use in all aspects of clinical dentistry for patients of all ages, with properties comparable to other common local anesthetic agents. Although there may be controversy regarding its safety and advantages in comparison to other local anesthetics, there is no conclusive evidence demonstrating neurotoxicity or significantly superior anesthetic properties of articaine for dental procedures. The choice whether to use articaine or another local anesthetic is based on the personal preference and experiences of individual clinicians. 3Currently, articaine is available as a 4% solution containing 1:100,000 or 1:200,000 epinephrine. Clinical trials comparing 4% with 2% solutions show no clinical advantage of 4% over a 2% solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, clinical trial with two parallel arms, to evaluate the safety and efficacy of 4% Articaine, 2% Mepivacaine on vital and non-vital primary teeth that needs restorative, pulp therapy, or dental extraction by using buccal infiltration technique. The effect will be assessed by measuring the pain experience during injection and treatment procedures, and by assessing the child's behavior during the procedure, and postoperative pain and complications. The study consisted of a screening period for up to 6 months. A Qualified participants through the screening assessments will be assigned randomly to receive either 4% Articaine, or 2% Mepivacaine.
| Arm | Type | Receives |
|---|---|---|
| 2% Mepivacaine with epinephrine 1:100,000. | Active comparator | Drug: Mepivacaine 2% with epinephrine 1:100,000Brand Name: 2% Medicaine with epinephrine 1:100,000. |
| 4% Articaine with epinephrine 1:100,000 | Experimental | Drug: Articaine (4%) with epinephrine 1:100,000Brand Name: 4% Septanest with epinephrine 1:100,000. |
Who may qualify
- Ages
- 36 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 1. They are Healthy (ASA 1: no acute or chronic disease, normal BMI percentile for age.
- They are 36 to 47 months old children.
- Intellectually qualified for communication.
- They have under gone either clinically indicated gingival abscess, dental caries or pathological root resorption or periapical radiolucency showing on the radiograph.
- Child's body weight at least 15 kg.
Key exclusion criteria (12 listed)
- Patients have allergic to local anesthetic with epinephrine (sulphites or amide).
- Intellectual or severe emotional problems. patient with intellectual development is significantly lower than average and his or her ability to adapt to the environment is consequently limited like autism, Down syndrome, fragile x syndrome, fetal alcohol syndrome, and Prader-Willi syndrome.
- Considerable behavior problems.
- Parents refuse participation in the trial.
- History of previous bad dental experience.
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 |
|---|---|---|
| Mepivacaine 2% with epinephrine 1:100,000Also: medicaine 2%Local Anesthesia | Drug | 2% Mepivacaine with epinephrine 1:100,000. |
| Articaine (4%) with epinephrine 1:100,000Also: septanest 4%Local Anesthesia | Drug | 4% Articaine with epinephrine 1:100,000 |
Primary outcome
Change in systolic and diastolic blood pressure (mmHg).
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
Normal blood pressure, defined as a systolic pressure less than 120, and a diastolic pressure less than 80.
Change in pulse rate (beats per minute).
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
Pulse rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
Change in respiratory rate (breaths per minute).
Time frame: 5 minutes before, during, and after 30 minutes of dental procedure.
The respiration rate is the number of breaths a person takes per minute.
Dental pain assessment: Frankl Behavior Rating Scale (FBRS).
Time frame: up to 30 minutes after dental procedure.
Frankl Behavior Rating Scale (FBRS) dichotomized into definitely negative (1), negative (2), positive (3), definitely positive (4).
Dental pain assessment: Faces, Legs, Activity, Cry, and Consolability. (FLACC).
Time frame: up to 30 minutes after dental procedure.
Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: relaxed and comfortable,1-3: mild discomfort, 4-6: moderate discomfort, 7-10: sever discomfort or pain or both.
1 secondary outcome
Post-operative complications.
Time frame: 24 hours after dental procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 32223002Elheeny AAH. Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial. Int J Paediatr Dent. 2020 Sep;30(5):547-555. doi: 10.1111/ipd.12640. Epub 2020 Apr 13.
- Background: PubMed 32797942Brignardello-Petersen R. Articaine and lidocaine probably have similar effects in 3- to 4-year-old children undergoing pulpotomy of a primary molar. J Am Dent Assoc. 2020 Oct;151(10):e93. doi: 10.1016/j.adaj.2020.06.029. Epub 2020 Aug 11. No abstract available.
- Background: PubMed 32383196Massignan C, Silveira Santos P, Cardoso M, Bolan M. Efficacy and adverse events of 4% articaine compared with 2% lidocaine on primary molar extraction: A randomised controlled trial. J Oral Rehabil. 2020 Aug;47(8):1031-1040. doi: 10.1111/joor.12989. Epub 2020 May 25.
- Background: PubMed 34053801Rayati F, Haeri M, Norouziha A, Jabbarian R. Comparison of the efficacy of 4% articaine with epinephrine 1:100,000 and 2% lidocaine with epinephrine 1:100,000 buccal infiltration for single maxillary molar extraction: a double-blind, randomised, clinical trial. Br J Oral Maxillofac Surg. 2021 Jul;59(6):695-699. doi: 10.1016/j.bjoms.2020.09.009. Epub 2020 Sep 11.
- Derived from this study: PubMed 37865418Alrashdi M, Alhunti A, Almansour A. Efficacy and safety of articaine in 3-year-old children for dental procedures: a protocol for a clinical randomised control trial in Saudi Arabia. BMJ Open. 2023 Oct 21;13(10):e077751. doi: 10.1136/bmjopen-2023-077751.
- 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.
Murad A. Alrashdi, ABPD study chair
Qassim University
Asya A. Almansour, SBPD principal investigator
Ministry of Health, Qassim cluster.
Atyaf A. Alhunti study director
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepivacaine 2% with epinephrine 1:100,000 and Articaine (4%) with epinephrine 1:100,000 in people with Dental Caries in Children and Dental Diseases, run by Qassim Health Cluster at 1 site in Saudi Arabia.
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 11 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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 Saudi Arabia. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in systolic and diastolic blood pressure (mmHg). (time frame: 5 minutes before, during, and after 30 minutes of dental procedure.). The study lists 5 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 NCT05839548, 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 27 Dec 2024.