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The goal of this clinical trial, is to test out the efficacy of using Articaine only as a local anesthesia as buccal infiltration to extract lower molar teeth.
Study will be performed in patients visiting Riyadh Elm University clinics seeking extraction of lower molars bilaterally, in each visit one molar tooth will be extracted using Ariticaine and the second visit with Lidocaine, pain level will be monitored and documented.
This study may be helpful in providing scientific information to the oral maxillofacial surgeons which will assist them in choosing the best local anesthetic agent, and possibly substituting using inferior alveolar nerve block with infiltration only when extracting the mandibular posterior teeth.
This is a double-blind, randomized clinical trial, which will involve 40 patients visiting the out-patient department of Oral and Maxillofacial surgery. For each patient, one mandibular molar will be extracted from right as well as left side, with one side being anesthetized using 4% articaine with 1:100,000 epinephrine and other with 2% lidocaine with 1:100,000 epinephrine buccal infiltration only. Evaluation and comparison will be done on the basis of pain prevalence exhibited by the patients while extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right mandibular molar | Experimental | Articaine 4% with 1:100,000 epinephrine |
|
| Left mandibular molar | Experimental | Lidocaine 2% with 1:100,000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml | Drug | 4% articaine with 1:100,000 epinephrine buccal infiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurement | Pain will be measured using the vial analogue scale | Pain will be measured after injection, during extraction procedure and at the end of the session immediately after finishing the procedure, scale of pain will be 0 for no pain and 10 for maximum pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albatool Baroom | Contact | +966562600600 | Albatool.a.baroom2021@student.riyadh.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Albatool Baroom | Albatool.a.baroom2021@student.riyadh.edu.sa | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15051743 | Result | Averbuch M, Katzper M. Assessment of visual analog versus categorical scale for measurement of osteoarthritis pain. J Clin Pharmacol. 2004 Apr;44(4):368-72. doi: 10.1177/0091270004263995. | |
| 26868800 | Result | Bartlett G, Mansoor J. Articaine buccal infiltration vs lidocaine inferior dental block - a review of the literature. Br Dent J. 2016 Feb 12;220(3):117-20. doi: 10.1038/sj.bdj.2016.93. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002355 | Carticaine |
| D004837 | Epinephrine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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One 1.8 ml cartridge of 4% articaine with 1:100,000 epinephrine will be utilized in the articaine group and one 1.8 ml cartridge of 2% lidocaine with 1:100,000 epinephrine will be utilized in the lidocaine group. The cartridges will be of similar size and shape, to be allotted a special code, enclosed in thin, adhesive tape by the distributor, and kept into one box for articaine and another box for lidocaine.
A 27-gauge needle will be used for buccal infiltration in each case. Any sensation of pain after administering the local anesthesia will be considered as a failure and an inferior alveolar nerve block will be given. Otherwise, the tooth will be extracted with no additional anesthesia.
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This is a double blinded randomized clinical trial, which neither the injector (investigator) nor the participant will know what anesthesia type was used in each session.
| Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml | Drug | 2% Lidocaine with 1:100,000 epinephrine buccal infiltration |
|
|
| 16320034 | Result | Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1. |
| 16554198 | Result | Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17. |
| 31028737 | Result | Majid OW, Muhammad ZA. Effectiveness of Articaine Buccal Infiltration Anesthesia for Mandibular Premolar Extraction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Oral Maxillofac Surg. 2019 Sep;77(9):1784-1789. doi: 10.1016/j.joms.2019.03.033. Epub 2019 Mar 30. |
| 28186223 | Result | Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466. |
| 30883236 | Result | Rathi NV, Khatri AA, Agrawal AG, M SB, Thosar NR, Deolia SG. Anesthetic Efficacy of Buccal Infiltration Articaine versus Lidocaine for Extraction of Primary Molar Teeth. Anesth Prog. 2019 Spring;66(1):3-7. doi: 10.2344/anpr-65-04-02. |
| 29980352 | Result | Rayati F, Noruziha A, Jabbarian R. Efficacy of buccal infiltration anaesthesia with articaine for extraction of mandibular molars: a clinical trial. Br J Oral Maxillofac Surg. 2018 Sep;56(7):607-610. doi: 10.1016/j.bjoms.2018.06.012. Epub 2018 Jul 3. |
| 17670879 | Result | Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12. doi: 10.14219/jada.archive.2007.0324. |
| 30887677 | Result | Soysa NS, Soysa IB, Alles N. Efficacy of articaine vs lignocaine in maxillary and mandibular infiltration and block anesthesia in the dental treatments of adults: A systematic review and meta-analysis. J Investig Clin Dent. 2019 Aug;10(3):e12404. doi: 10.1111/jicd.12404. Epub 2019 Mar 18. |
| 29043507 | Result | Thiem DGE, Schnaith F, Van Aken CME, Kontges A, Kumar VV, Al-Nawas B, Kammerer PW. Extraction of mandibular premolars and molars: comparison between local infiltration via pressure syringe and inferior alveolar nerve block anesthesia. Clin Oral Investig. 2018 Apr;22(3):1523-1530. doi: 10.1007/s00784-017-2251-7. Epub 2017 Oct 17. |
| D006571 |
| Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| 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 |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |