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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Mepivacaine with epinephrine 1:100,000. | Active Comparator | Brand Name: 2% Medicaine with epinephrine 1:100,000. |
|
| 4% Articaine with epinephrine 1:100,000 | Experimental | Brand Name: 4% Septanest with epinephrine 1:100,000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine 2% with epinephrine 1:100,000 | Drug | Local Anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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. | up to 30 minutes after dental procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours after dental procedure. |
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Inclusion criteria:
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.
Exclusion criteria:
Patients are excluded from the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Murad A. Alrashdi, ABPD | Qassim University | Study Chair |
| Asya A. Almansour, SBPD | Ministry of Health, Qassim cluster. | Principal Investigator |
| Atyaf A. Alhunti | Qassim University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qassim University | Burayadh | Al-Qassim Region | 51452 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32223002 | Background | 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. | |
| 32797942 | Background | Brignardello-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. |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D003788 | Dental Pulp Diseases |
| D002652 | Child Behavior |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| D004837 | Epinephrine |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
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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.
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| Articaine (4%) with epinephrine 1:100,000 | Drug | Local Anesthesia |
|
|
| 32383196 | Background | Massignan 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. |
| 34053801 | Background | Rayati 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. |
| 37865418 | Derived | Alrashdi 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |