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The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buffered Local Anesthesia | Experimental | Participants will receive buffered local anesthesia during dental treatment for pulpitis. The local anesthetic solution will consist of lidocaine with epinephrine combined with sodium bicarbonate to increase pH prior to administration. The intervention will be applied via local infiltration or nerve block as clinically indicated for pulpotomy or pulpectomy procedures in primary maxillary molars |
|
| Conventional Local Anesthesia | Active Comparator | Participants will receive conventional local anesthesia during dental treatment for pulpitis. The anesthetic solution will consist of lidocaine with epinephrine administered without buffering. The intervention will be applied via local infiltration or nerve block according to clinical indication for pulpotomy or pulpectomy procedures in primary maxillary molars. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buffered Lidocaine with Epinephrine | Drug | Local anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| FLACC PAIN SCORE | Pain behavior will be assessed using the FLACC(Face, Legs, Activity, Cry, and Consolability) Scale score, during different phases of dental treatment in children with pulpitis receiving local anesthesia. The scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain intensity and a worse outcome. | Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological indicators (Heart Rate) | Description: Heart rate will be recorded using a blood volume pulse (BVP) sensor during dental treatment. Unit of Measure: Beats per minute (bpm) | Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mayte A Condori Chambi, Cirujano Dentista | Contact | +524446641295 | maytecondori97@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma de San Luis Potosí | Recruiting | San Luis Potosí City | San Luis Potosí | 78290 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29377171 | Background | Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21. | |
| 30087760 | Background | Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20. |
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Participants will receive one of two interventions during routine dental treatment: buffered local anesthesia or conventional local anesthesia. Clinical procedures may include pulpotomy or pulpectomy depending on diagnosis. Pain, anxiety, and anesthetic efficacy outcomes will be assessed during different phases of treatment.
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Participants, the treating clinician, and the outcome assessors will be blinded to group allocation. Allocation concealment will be ensured using a block randomization method.
Group assignment will be coded as Group A and Group B, and concealed in sealed, opaque containers until the end of data analysis.
| idocaine with Epinephrine (Conventional) | Drug | Standard commercially available local anesthetic solution used in routine dental practice without pH modification |
|
| Physiological indicators (Skin Conductance) |
Description: Skin conductance will be measured using electrodermal activity (EDA) sensors during dental treatment. Unit of Measure: MicroSiemens (µS) |
| Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) |
| Wong-Baker Faces Pain Rating Scale Score | Self-reported pain whit Wong-Baker Faces Pain Rating Scale will be recorded at predefined clinical stages of treatment. Scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst pain possible | Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure) |
| Onset of local anesthesia | Description: Time elapsed from completion of local anesthetic injection until confirmation of pulpal anesthesia. Pulpal anesthesia will be verified using cold testing (Endo Ice) after confirmation of soft tissue anesthesia. Unit of Measure: Minutes and seconds | From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit. |
| Duration of soft tissue anesthesia | Description: Time elapsed from confirmed loss of soft tissue sensation following local anesthetic administration until complete recovery of sensation as reported by the participant's caregiver. Unit of Measure: Minutes | From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment. |
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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