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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatherapy (Lemongrass Essential Oil) | Experimental | Participants receive aromatherapy using lemongrass essential oil delivered through an electric diffuser during the orthodontic extraction procedure. Two drops of lemongrass essential oil are diluted in 100 mL of water and diffused in the operatory environment starting approximately 30 minutes before the extraction procedure and continued throughout the procedure. In the split-mouth study design, this intervention is applied during one of the extraction sessions. |
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| Placebo Aromatherapy (Distilled Water Diffusion) | Placebo Comparator | Participants receive placebo aromatherapy using distilled water diffusion during the orthodontic extraction procedure. Distilled water is placed in the same electric diffuser under identical environmental conditions starting 30 minutes before the extraction procedure and continued throughout the procedure. This serves as the control condition in the split-mouth design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemongrass Aromatherapy | Other | Lemongrass essential oil diluted in water and administered using an electric diffuser in the dental operatory to provide inhalational aromatherapy during the extraction procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 24 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure measured in millimeters of mercury (mmHg)90-140 mmHg. Higher values may indicate increased physiological stress.(worse outcome) | Baseline (pre-procedure), intra-procedural (during local anesthesia administration), and immediately post-procedure (within 30 minutes after extraction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Virendra Singh, MDS | Postgraduate Institute of Dental Sciences Rohtak | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIDS, Rohtak | Rohtak | Haryana | 124001 | India |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Aromatherapy | Other | Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil. |
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| Diastolic Blood Pressure |
Diastolic blood pressure measured in millimeters of mercury (mmHg)60-90. Higher values may indicate increased physiological stress.(worse outcome) |
| 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) | 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) | 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) | Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction) |