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This randomized controlled clinical trial aims to evaluate and compare the effectiveness of chamomile extract and valerian extract in reducing dental anxiety in healthy pediatric patients aged 6 to 10 years undergoing tooth extraction. Participants will be randomly assigned to receive one of the herbal interventions or a placebo prior to extraction. Dental anxiety will be assessed using validated anxiety rating scales and physiological parameters. This study seeks to explore a safe, easy to apply, and effective approach to manage child behavior and reduce dental anxiety.
Dental anxiety in children is a common issue that can negatively affect oral health, behavior, and overall well-being. While various pharmacological and non-pharmacological strategies exist to manage pediatric dental anxiety, there is still a need for approaches that are safe, accessible, and practical for routine clinical use. Herbal interventions, such as chamomile and valerian, have demonstrated anxiolytic and sedative effects in other medical settings, but their comparative effectiveness in reducing dental anxiety in children has not been fully studied.
This randomized controlled trial investigates the potential of these herbal extracts to reduce anxiety in children aged 6-10 years undergoing simple tooth extraction. Participants will be randomly assigned to one of three groups, receiving either chamomile, valerian, or a placebo prior to treatment. Anxiety will be assessed using multiple complementary methods: a child-friendly self-report scale, an observer-rated behavior scale, and physiological measures including blood pressure and heart rate.
By combining these assessment tools, the study provides a comprehensive evaluation of both psychological and physiological aspects of dental anxiety. The findings will offer insights into whether these herbal extracts can reduce dental anxiety safely and effectively, guiding pediatric dentists in implementing natural interventions to improve children's dental experiences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valerian extract | Experimental |
| |
| Chamomile extract | Experimental |
| |
| Water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valerian extract | Dietary Supplement | Participants will receive 1 mL of valerian root liquid extract (Valeriana officinalis L., 1000 mg/mL), diluted in a small amount of apple juice, 30 minutes prior to local anesthesia and tooth extraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported dental anxiety level | Dental anxiety will be assessed using the Animated Emoji Scale (AES); a scale that consists of five facial expressions (emojis) scored from 1 (no anxiety) to 5 (high anxiety). | Before the herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia - immediately after extraction. |
| Non-self-reported dental anxiety level | Dental anxiety will be assessed using the Houpt Behavior Rating Scale, by an independent external observer based on video recordings. | Throughout the dental procedure: 1. during local anesthesia (from needle insertion until needle withdrawal) 2. during extraction (from the initial application of forceps until complete tooth removal) |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological response to dental anxiety - Heart rate | Heart rate will be measured using an electronic digital blood pressure monitor with a sleeve designed for children | Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia |
| Physiological response to dental anxiety - Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juman Hayo, DDS | Faculty of Dentistry, University of Damascus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38784853 | Background | Saadatmand S, Zohroudi F, Tangestani H. The Effect of Oral Chamomile on Anxiety: A Systematic Review of Clinical Trials. Clin Nutr Res. 2024 Apr 23;13(2):139-147. doi: 10.7762/cnr.2024.13.2.139. eCollection 2024 Apr. | |
| 32795578 | Background | Chaves PFP, Hocayen PAS, Dallazen JL, de Paula Werner MF, Iacomini M, Andreatini R, Cordeiro LMC. Chamomile tea: Source of a glucuronoxylan with antinociceptive, sedative and anxiolytic-like effects. Int J Biol Macromol. 2020 Dec 1;164:1675-1682. doi: 10.1016/j.ijbiomac.2020.08.039. Epub 2020 Aug 11. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000713890 | Valeriana extract |
| C000713170 | Chamomile extract |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Chamomile extract | Dietary Supplement | Participants will receive 2 ml of German chamomile flower liquid extract (Matricaria recutita, 2400 mg/2 mL), diluted in a small amount of water, 30 minutes prior to local anesthesia and tooth extraction. |
|
| Water (Placebo) | Other | Participants will receive a small amount of water 30 minutes prior to local anesthesia and tooth extraction. |
|
Systolic and diastolic blood pressure will be measured using an electronic digital blood pressure monitor with a sleeve designed for children |
| Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia |
| 24741279 | Background | Pinheiro ML, Alcantara CE, de Moraes M, de Andrade ED. Valeriana officinalis L. for conscious sedation of patients submitted to impacted lower third molar surgery: A randomized, double-blind, placebo-controlled split-mouth study. J Pharm Bioallied Sci. 2014 Apr;6(2):109-14. doi: 10.4103/0975-7406.129176. |
| 39514279 | Background | Zampieri VC, Goncalves IL, Lira AL, Zeni J, Backes GT, Hsu AKW. Exploring the Effects of a Calming Herbal Tea Blend on Perioperative Anxiety: A Randomized Clinical Trial. J Med Food. 2025 Mar;28(3):266-271. doi: 10.1089/jmf.2024.0170. Epub 2024 Nov 8. |
| 24837472 | Background | Gromball J, Beschorner F, Wantzen C, Paulsen U, Burkart M. Hyperactivity, concentration difficulties and impulsiveness improve during seven weeks' treatment with valerian root and lemon balm extracts in primary school children. Phytomedicine. 2014 Jul-Aug;21(8-9):1098-103. doi: 10.1016/j.phymed.2014.04.004. Epub 2014 May 15. |
| 38743126 | Background | Velasquez ACA, Tsuji M, Dos Santos Cordeiro L, Petinati MFP, Rebellato NLB, Sebastiani AM, da Costa DJ, Scariot R. Effects of Passiflora incarnata and Valeriana officinalis in the control of anxiety due to tooth extraction: a randomized controlled clinical trial. Oral Maxillofac Surg. 2024 Sep;28(3):1313-1320. doi: 10.1007/s10006-024-01259-6. Epub 2024 May 14. |
| 31158346 | Background | Farah GJ, Ferreira GZ, Danieletto-Zanna CF, Luppi CR, Jacomacci WP. Assessment of Valeriana officinalis l. (Valerian) for Conscious Sedation of Patients During the Extraction of Impacted Mandibular Third Molars: A Randomized, Split-Mouth, Double-Blind, Crossover Study. J Oral Maxillofac Surg. 2019 Sep;77(9):1796.e1-1796.e8. doi: 10.1016/j.joms.2019.05.003. Epub 2019 May 9. |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |