Anxiety, Dental
Conditions
Keywords
dental anxiety, pediatric dentistry, herbal medicine, phytotherapy, chamomile, valerian, behavior management
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTChamomile extract
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.
OTHERWater (Placebo)
Participants will receive a small amount of water 30 minutes prior to local anesthesia and tooth extraction.
DIETARY_SUPPLEMENTValerian extract
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.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1\. Healthy children with no systemic or mental diseases. 2. Children aged 6-10 years. 4. Children with positive behavior according to the Frankl behavior rating scale. 5\. Children requiring a simple tooth extraction of upper primary molars under local anesthesia.
Exclusion criteria
1. Children whose parents refused participation in the study. 2. Children who were unwilling to ingest any of the herbal extracts. 3. Children with a history of hypersensitivity to chamomile or valerian. 4. Children who had taken any sedative, anxiolytic or analgesic medications within the last 8 hours prior to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported dental anxiety level | Before the herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia - immediately after extraction. | 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). |
| Non-self-reported dental anxiety level | 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) | Dental anxiety will be assessed using the Houpt Behavior Rating Scale, by an independent external observer based on video recordings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological response to dental anxiety - Heart rate | Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia | Heart rate will be measured using an electronic digital blood pressure monitor with a sleeve designed for children |
| Physiological response to dental anxiety - Blood pressure | Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia | Systolic and diastolic blood pressure will be measured using an electronic digital blood pressure monitor with a sleeve designed for children |
Countries
Syria
Contacts
CONTACTJuman Hayo, MSc Student
CONTACTNada Bshara, Professor
PRINCIPAL_INVESTIGATORJuman Hayo, DDS
Faculty of Dentistry, University of Damascus
Outcome results
None listed