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This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Each child received standard anesthetic on one side and buffered anesthetic on the other. Pain levels and onset time were measured to assess anesthetic efficacy.
This randomized, controlled, double-blinded, split-mouth clinical trial aims to evaluate the efficacy of buffering local anesthetic solution with sodium bicarbonate in the extraction of infected and inflamed primary molars in children. Infected tissues tend to have a lower PH , which can limit the effectiveness of local anesthetics by reducing the proportion of the active, non-ionized drug form. buffering with sodium bicarbonate improve anesthetic performance by raising the pH of the solution, enhancing its diffusion and clinical effectiveness.
The study included 20 healthy children aged 6 to 10 years, each with two infected or inflamed primary molars located on opposite sides of the maxilla. A split-mouth design was employed, where each child received a standard local anesthetic solution - lidocaine 2% with epinephrine 1:80,000 - on one side, and a buffered solution (alkalinized with sodium bicarbonate) on the contralateral side.
To assess anesthetic efficacy, three parameters were measured: pulse rate (as a physiologic indicator of pain), the Sound-Eye-Motor (SEM) scale (for behavioral response), and the Wong-Baker Faces Pain Rating Scale (for subjective pain reporting). Onset time of anesthesia was also recorded.
The study aims to determine whether buffering lidocaine with sodium bicarbonate improves pain control and onset time during pediatric dental extractions in inflamed and infected tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Local Anesthetic | Active Comparator | Participants receive the standard local anesthetic solution-lidocaine 2% with epinephrine 1:80,000-for extraction of infected and inflamed primary molars. |
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| Buffered Local Anesthetic | Experimental | Participants receive a buffered local anesthetic solution-lidocaine 2% with epinephrine 1:80,000 buffering with sodium bicarbonate-to assess enhanced anesthetic efficacy during extraction of infected and inflamed primary molars. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unbuffered lidocaine 2% with epinephrine 1:80,000 | Drug | Standard local anesthetic solution without pH modification. Used for maxillary extraction of infected primary molars in pediatric patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level during tooth extraction in inflamed sites (self-reported) | Procedural pain during extraction was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain. This scale uses six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to indicate the face that best matched their pain level during tooth extraction in inflamed areas. Higher scores indicate greater pain intensity. | During the tooth extraction procedure |
| Pain-related behavioral response during extraction in inflamed primary molars (observer-rated) | Procedural pain behavior will be assessed using the Sound-Eye-Motor (SEM) scale. Trained observers will score behavioral responses during extraction; higher scores indicate stronger pain-related behavior. | During the tooth extraction procedure |
| Physiological response during extraction in inflamed primary molars (heart rate) | Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction. | through the extraction procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain perception during injection of anesthetic solution (self-reported) | Pain during injection will be self-reported using the Wong-Baker FACES Pain Rating Scale. Children indicate the face that best matches injection pain (0-10) | During and within 1 minute after anesthetic injection |
| Behavioral response during anesthetic injection (SEM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University | Latakia | Latakia Governorate | Syria |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Buffered lidocaine 2% with epinephrine 1:80,000 | Drug | Local anesthetic solution mixed with sodium bicarbonate to increase pH before injection. Used for maxillary extraction of infected primary molars in pediatric patients. |
|
Observer-rated SEM scores will be recorded during anesthetic injection to evaluate behavioral response to injection pain |
| During and within 1 minute after anesthetic injection |
| Physiological response to injection (heart rate) | Heart rate (beats per minute) will be recorded before, during, and immediately after injection. Changes from baseline will be used as an objective marker of pain/stress | During anesthetic injection |
| 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 |