Skip to main content
OpenTrials
Completed

NCT Number: NCT07506135

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

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)?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Anxiety Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIDS, Rohtak

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo Aromatherapy

Other

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

Primary outcomes

  1. Pain perception during and after tooth extraction

    Time frame: 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).

  2. Dental anxiety during extraction procedure

    Time frame: 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).

  3. Oral health-related quality of life following extraction

    Time frame: 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 outcomes

  1. Systolic Blood Pressure

    Time frame: 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)

  2. Diastolic Blood Pressure

    Time frame: 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)

  3. Heart Rate

    Time frame: 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)

  4. Respiratory Rate

    Time frame: 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)

  5. Oxygen Saturation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.