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)?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Lemongrass essential oil diluted in water and administered using an electric diffuser in the dental operatory to provide inhalational aromatherapy during the extraction procedure.
Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.
PGIDS, Rohtak
Rohtak, Haryana, India
Pain perception during and after tooth extraction
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).
Time frame: Peri-procedural (during local anesthesia administration and forceps application), and at 2 hours, 12 hours, 24 hours, and 48 hours post-procedure
Dental anxiety during extraction procedure
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).
Time frame: Baseline (pre-procedure) and immediately post-procedure (within 30 minutes after extraction)
Oral health-related quality of life following extraction
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).
Time frame: 24 hours post-procedure
Systolic Blood Pressure
Systolic blood pressure measured in millimeters of mercury (mmHg)90-140 mmHg. Higher values may indicate increased physiological stress.(worse outcome)
Time frame: Baseline (pre-procedure), intra-procedural (during local anesthesia administration), and immediately post-procedure (within 30 minutes after extraction)
Diastolic Blood Pressure
Diastolic blood pressure measured in millimeters of mercury (mmHg)60-90. Higher values may indicate increased physiological stress.(worse outcome)
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Heart Rate
Heart rate measured in beats per minute (bpm)60-100. Higher values may indicate increased physiological stress.(worse outcome)
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Respiratory Rate
Respiratory rate measured in breaths per minute12-20. Higher values may indicate increased physiological stress.(worse outcome)
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Oxygen Saturation
Oxygen saturation measured as percentage (%) SpO₂ 95-100%. Lower values may indicate physiological compromise or stress.(worse outcome)
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
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