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IRCT20230313057710N3 IRCT 2023-08-14 Esfahan University of Medical Sciences Effect of prewarming and precooling of mucosal injection site on maxillary central incisor labial infiltration anesthesia pain Effect of prewarming and precooling of mucosal injection site on maxillary central incisor labial infiltration anesthesia pain 2017-12-23 anticipated 20 Complete https://irct.ir/trial/71624 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: A clinical trial study was designed in which each participant received 3 injections in 3 consecutive days on the same central maxillary tooth. The statistician used the random assignment by lottery for determining sequence of intervention allocation to the participants. Therefore, the participants were assigned on the first day as the control group (receiving labial infiltration injection of unilateral maxillary central tooth), on the second day as experimental group 1 (applying an ice pack), and on the third day as experimental group 2 (warm pack). Comparison of pain between groups (after intervention) and before-after was done, Randomization description: In the present study, the participants in the control, intervention 1 and intervention 2 groups were the same, and selected using available sampling method. The statistician used the random assignment by lottery for determining sequence of intervention allocation to the participants. Therefore, the participants were assigned on the first day as the control group, on the second day as experimental group 1 (applying an ice pack), and on the third day as experimental group 2 (warm pack), Blinding description: Blinding of participants was not possible due to the nature of the study. However, the statistician who analyzed the results was blinded to the group allocation of data. N/A Maxillary central incisor labial infiltration anesthesia pain. Intervention 1: Intervention group1: َAfter placing an ice pack over the injection site in the labial mucosa for 1 minute, Labial infiltration anesthesia of maxillary central incisors with local anesthesia (lidocaine) was done. The ice pack was fabricated by filling the fingers of a Latex glove with water, tying it, cutting the rest of the glove, and placing it in a freezer. All ice packs were checked to ensure 0°C temperature without thawing. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Intervention 2: Intervention group2: After placing an heat pack over the injection site in the labial mucosa for 1 minute, Labial infiltration anesthesia of maxillary central incisors with local anesthesia (lidocaine) was done. The heat pack was fabricated by filling a Latex glove with water, tying it, and heating it in a water bath at 50°C (Figure 1). The water temperature was measured after removal from the water bath and prior to placement over the mucosa. To obtain optimal results, a minimum temperature rise of 3-4°C of the mucosa was required. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Intervention 3: Control group: Labial infiltration anesthesia of maxillary central incisors was performed with lidocaine without the intervention of cold or heat packs. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If the article is submitted and the data file is needed, it will be made available
public Zahra Khosravani
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 khosravanii.zahra73sums@gmail.com Esfahan University of Medical Sciences scientific Armita Vali Sichani
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 a.valisichani@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Presence of sound maxillary central and lateral incisors no limit no limit Both History of anaphylactic shock Pregnancy History of trauma to maxillary central incisors History of allergy to lidocaine and sulfide Present of severe periodontal disease Intake of medications affecting pain perception (such as beta blockers and opioids) Intake of medications interacting with local anesthetic agent Present of fever, and systemic diseases K00-K14 XI Diseases of the digestive system Treatment - Devices Treatment - Devices Treatment - Other Intervention group1: َAfter placing an ice pack over the injection site in the labial mucosa for 1 minute, Labial infiltration anesthesia of maxillary central incisors with local anesthesia (lidocaine) was done. The ice pack was fabricated by filling the fingers of a Latex glove with water, tying it, cutting the rest of the glove, and placing it in a freezer. All ice packs were checked to ensure 0°C temperature without thawing. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Intervention group2: After placing an heat pack over the injection site in the labial mucosa for 1 minute, Labial infiltration anesthesia of maxillary central incisors with local anesthesia (lidocaine) was done. The heat pack was fabricated by filling a Latex glove with water, tying it, and heating it in a water bath at 50°C (Figure 1). The water temperature was measured after removal from the water bath and prior to placement over the mucosa. To obtain optimal results, a minimum temperature rise of 3-4°C of the mucosa was required. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Control group: Labial infiltration anesthesia of maxillary central incisors was performed with lidocaine without the intervention of cold or heat packs. All injections were performed by an aspirating dental injection syringe (Novocol Ontario, Canada) with a short 27-gauge needle (Made in France). 0.6 mL of 2% lidocaine with 1:80,000 Epinephrine was injected into the labial vestibule of maxillary central incisor. The needle was inserted into the tissue by 3-5 mm, aspiration was performed, and the anesthetic agent was released. Upon completion of injection, the participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS) , and Wong-Baker Faces pain rating scale (WBFPRS). Maxillary central incisor labial infiltration anesthesia pain. Timepoint: During needle insertion and release of anesthetic agent. Method of measurement: The participants expressed the level of pain they experienced during needle insertion and release of anesthetic agent using a 100-mm visual analog scale (VAS), and Wong-Baker Faces pain rating scale. Esfahan University of Medical Sciences Approved 2019-06-26 Research Ethix Committee of Isfahan University of Medical Sciences Hezar Jerib street, Isfahan University of Medical Sciences, , Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)