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

NCT07506135 | Completed

• 1 other identifier: Rashmi Bawane
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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)?

Conditions

Dental Anxiety; Pain

Keywords

Aromatherapy; Lemongrass essential oil; Orthodontic extraction; Maxillary premolar; Dental anxiety; Split-mouth trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Systolic Blood Pressure

  Baseline (pre-procedure), intra-procedural (during local anesthesia administration), and immediately post-procedure (within 30 minutes after extraction)

• Diastolic Blood Pressure

  Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)

• Heart Rate

  Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)

• Respiratory Rate

  Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)

• Oxygen Saturation

  Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)

Study Arms (2)

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.

Other: Lemongrass Aromatherapy

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.

Other: Placebo Aromatherapy

Interventions

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.

Aromatherapy (Lemongrass Essential Oil)

Placebo Aromatherapy OTHER

Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.

Placebo Aromatherapy (Distilled Water Diffusion)

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Virendra Singh, MDS

  Postgraduate Institute of Dental Sciences Rohtak

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: April 1, 2026
• Study Start: November 20, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IN (1)