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IRCT20250811066815N1 IRCT 2025-08-13 Tehran University of Medical Sciences The effect of lavender and clove herbal topical anesthetics compared to benzocaine on dental injection pain in children A randomized clinical trial study of the effect of lavender and clove herbal topical anesthetics compared to benzocaine on dental injection pain in children 2025-09-06 anticipated 24 Complete https://irct.ir/trial/85462 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Given the six possible sequential models for the interventions, randomization of the samples is performed using blocks of six and with the aid of Excel software. The randomization process is conducted by the study’s methodology consultant, and the other researchers are blinded to the allocation sequence. Once the intervention order is determined, the allocation for each patient is placed sequentially in sealed, numbered envelopes. During the intervention phase, these envelopes are opened in order, and the interventions are carried out accordingly, Blinding description: Blinding in the study is implemented through three methods: 1) The three topical gels are made to appear identical, 2) The operator is unaware of the order in which the gels are applied, 3) The evaluator is unaware of the order in which the gels are applied. N/A Topical anesthesia with lavender, clove, and benzocaine. Intervention 1: Intervention group: Lavender essential oil. Intervention 2: Intervention group: Clove essential oil. Intervention 3: Control group: Topical benzocaine gel. Yes - There is a plan to make this available What will be shared: All data may be shared, provided that individuals have been properly de-identified. When: Access to the data will commence two months following the publication of the results. To whom: Researchers working at academic and research institutions Conditions: Data may be used for future research in dental science without restriction Where to obtain: Alavi137516.ha@gmail.com How to obtain: The requester must submit their application via the platform or email. After initial review and approval, a confidentiality agreement will be sent. Once the signed form is received, the data will be prepared and delivered. Estimated time to receive the files: 2 to 4 weeks, depending on data volume and number of requests. Comments:
public Haniyeh Alavi Milani
No. 36, Shahin Alley, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۵۶۹۱۶۸۳۱ +98 21 6650 5740 alavi137516.ha@gmail.com Tehran University of Medical Sciences scientific Haniyeh Alavi Milani
Unit 9, No. 36, Shahin Alley, Sattarkhan Street
Tehran Iran (Islamic Republic of) ۱۴۵۶۹۱۶۸۳۱ +98 21 6650 5740 alavi137516.ha@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) ASA physical status classification I and II according to the American Society of Anesthesiologists (ASA). Frankl behavioral rating score of 3 (positive) or 4 (definitely positive). No use of analgesics or sedatives in the past 12 hours. All patients require 3 treatment sessions by infiltration injection of posterior maxillary teeth. All patients have the ability to establish appropriate verbal communication. 6 years 8 years Both Have systemic disease. Have anxiety disorder and phobia. Have abscess or fascial space infection. Presence of any pathology in the injection area. Children with behavioral and learning disorders. Children with a history of dental treatment. Children with a history of allergy (food, plants, etc.). Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Lavender essential oil Intervention group: Clove essential oil Control group: Topical benzocaine gel The amount of pain of anesthetic local injection. Timepoint: Post-anesthetic injection. Method of measurement: Face, Legs, Activity, Cry, Consolability. The amount of pain of anesthetic local injection. Timepoint: Post-anesthetic injection. Method of measurement: Faces Pain Scale-Revised. Aste of the topical anesthetic gel. Timepoint: Post anesthesia injection. Method of measurement: Child’s selection from good, average, and bad. Tehran University of Medical Sciences Approved 2025-04-28 Ethics Committee of Tehran University of Medical Sciences No. 36, Shahin Ave., Sattarkhan Ave,. Tehran Tehran Iran (Islamic Republic of)