Effect of Aromatherapy on Pain and Anxiety During Orthodontic Extraction of Maxillary Premolars.

The Role of Aromatherapy in Orthodontic Extraction of Maxillary Premolars: A Randomized Controlled Split-Mouth Clinical Trial.

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)?

Study Overview

• Status: Completed
• Conditions: Pain; Dental Anxiety
• Intervention / Treatment: Other: Lemongrass Aromatherapy; Other: Placebo Aromatherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS, ROHTAK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aromatherapy (Lemongrass Essential Oil); 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.	Other: Lemongrass 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.
Placebo Comparator: Placebo Aromatherapy (Distilled Water Diffusion); 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.	Other: Placebo Aromatherapy; Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Study Director: Dr Virendra Singh, MDS, Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): January 7, 2026
• Study Completion (Actual): January 7, 2026

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Aromatherapy; Dental anxiety; Orthodontic extraction; Split-mouth trial; Lemongrass essential oil; Maxillary premolar
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: Rashmi Bawane

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No