Dental Anxiety, Pain
Conditions
Keywords
Aromatherapy, Lemongrass essential oil, Orthodontic extraction, Maxillary premolar, Dental anxiety, Split-mouth trial
Brief summary
The goal of this randomized placebo-controlled split-mouth clinical trial is to determine whether aromatherapy using lemongrass essential oil can reduce pain, dental anxiety, and physiological stress responses during orthodontic extraction of maxillary premolars . The main questions it aims to answer are: * Does aromatherapy reduce pain perception during and after tooth extraction as measured by the Visual Analog Scale (VAS)? * Does aromatherapy reduce dental anxiety and improve oral health-related quality of life during the extraction procedure as measured by the Modified Dental Anxiety Scale (MDAS-DEP) and Oral Health Impact Profile-14 (OHIP-14)?
Detailed description
Title: The Role of Aromatherapy in Orthodontic Extraction of Maxillary Premolars- A Randomized Controlled Trial This study was conducted in patients aged 12 to 25 years requiring bilateral orthodontic extraction of maxillary premolars. In a randomized split-mouth design, one side was assigned to active aromatherapy using lemongrass essential oil diffused in water, while the contralateral side received placebo aromatherapy using distilled water under identical environmental conditions. Extraction procedures were standardized for both groups. Pain was assessed using the Visual Analog Scale during local anesthesia administration, forceps application, and at 2, 12, 24, and 48 hours postoperatively. Dental anxiety was assessed using the Modified Dental Anxiety Scale for Dental Extraction Procedure, while oral health-related quality of life was assessed using OHIP-14. Vital signs including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation were recorded preoperatively, intraoperatively, and postoperatively. The objective was to determine whether aromatherapy can serve as a safe non-pharmacological adjunct for improving patient comfort during orthodontic premolar extractions.
Interventions
OTHERLemongrass Aromatherapy
Lemongrass essential oil diluted in water and administered using an electric diffuser in the dental operatory to provide inhalational aromatherapy during the extraction procedure.
OTHERPlacebo Aromatherapy
Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients indicated for bilateral orthodontic extraction of maxillary first or second premolars * Age 12 to 25 years * Willing to provide informed consent/assent as applicable
Exclusion criteria
* Use of medication within 15 days before the study * Hypersensitivity to drugs, substances, or materials used in the trial * Smokers * Pregnancy or lactation * Inability to complete the questionnaire * Preoperative inflammatory or infectious condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception during and after tooth extraction | Peri-procedural (during local anesthesia administration and forceps application), and at 2 hours, 12 hours, 24 hours, and 48 hours post-procedure | Measure: Pain intensity assessed using a Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Higher scores indicate greater pain intensity (worse outcome). |
| Dental anxiety during extraction procedure | Baseline (pre-procedure) and immediately post-procedure (within 30 minutes after extraction) | Measure: Anxiety assessed using the Modified Dental Anxiety Scale for Dental Extraction Procedure (MDAS-DEP). The scale consists of 5 items with total scores ranging from 5 to 25, where: 5 = No anxiety 25 = Extreme anxiety Higher scores indicate greater anxiety levels (worse outcome). |
| Oral health-related quality of life following extraction | 24 hours post-procedure | Measure: Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. Scores range from 0 to 56, where: 0 = No impact (best quality of life) 56 = Maximum negative impact (worst quality of life) Higher scores indicate poorer oral health-related quality of life (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Baseline (pre-procedure), intra-procedural (during local anesthesia administration), and immediately post-procedure (within 30 minutes after extraction) | Systolic blood pressure measured in millimeters of mercury (mmHg)90-140 mmHg. Higher values may indicate increased physiological stress.(worse outcome) |
| Diastolic Blood Pressure | Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction) | Diastolic blood pressure measured in millimeters of mercury (mmHg)60-90. Higher values may indicate increased physiological stress.(worse outcome) |
| Heart Rate | Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction) | Heart rate measured in beats per minute (bpm)60-100. Higher values may indicate increased physiological stress.(worse outcome) |
| Respiratory Rate | Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction) | Respiratory rate measured in breaths per minute12-20. Higher values may indicate increased physiological stress.(worse outcome) |
| Oxygen Saturation | Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction) | Oxygen saturation measured as percentage (%) SpO₂ 95-100%. Lower values may indicate physiological compromise or stress.(worse outcome) |
Countries
India
Contacts
STUDY_DIRECTORDr Virendra Singh, MDS
Postgraduate Institute of Dental Sciences Rohtak
Outcome results
None listed