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The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.
The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. According to studies, under the assumption that a difference of 5 units in the number of patients would be considered significant, it was planned to include at least 5 patients in each group at 95 power and α=0.05 significance level. However, the number of patients has been updated to 96 by increasing the effect size for more meaningful results.
6 different groups will be formed in patients.
Among the different pain assessment methods reported in the literature, rating scales to measure their intensity are mostly used in clinical studies as they represent themselves. The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line.
The dentist who performed the tooth extraction marked the line representing the level of pain intensity perceived by the patients. The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a scale from 0 to 10 indicated on the scale... Face 0 does not hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine' it denotes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) | Before extraction, buccal and palatal infiltration anesthesia with articaine will perform. Following anesthesia, extraction will carry out. |
| |
| Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) | Before extraction, buccal and palatal infiltration anesthesia with lidocaine will perform. Following anesthesia, extraction will carry out. |
| |
| Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl) | Before extraction, buccal infiltration anesthesia with articaine will perform. After 5 minutes, extraction will carry out. |
| |
| Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl) | Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 5 minutes, extraction will carry out. |
| |
| Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl) | Before extraction, buccal infiltration anesthesia with articaine will perform. After 8 minutes, extraction will carry out. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Articaine Hydrochloride + Epinephrine | Drug | Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction. Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain during tooth extraction after anesthesia with VAS | The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line | baseline and maximum 8 minutes |
| Evaluation of pain during tooth extraction after anesthesia with Wong-Baker | The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a score from 0 to 10, indicated on the scale. it means that Face 0 doesn't hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine | baseline and maximum 8 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevser sancak | Contact | +905556446580 | kevsersancak89@gmail.com | |
| Ceren Tatlı | Contact |
| Name | Affiliation | Role |
|---|---|---|
| ceren tatlı, assist.Prof | Ankara Yildirim Beyazıt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Yıldırım beyazıt University, Faculty of Dentistry | Recruiting | Ankara | 06790 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30417227 | Background | Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12. | |
| 28646527 | Background | Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24. |
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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 |
| C030488 | Ultracaine D-S |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) | Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 8 minutes, extraction will carry out. |
|
|
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| Lidocaine Hydrochloride + Epinephrine | Drug | Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group |
|
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| 17138173 | Result | Uckan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):733-5. doi: 10.1016/j.tripleo.2005.12.005. Epub 2006 Mar 20. |
| 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 |