Clinical Trials Directory

Trials / Completed

CompletedNCT07506135

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
Sex
All
Age
12 Years – 25 Years
Healthy volunteers
Accepted

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)?

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.

Conditions

Interventions

TypeNameDescription
OTHERLemongrass AromatherapyLemongrass essential oil diluted in water and administered using an electric diffuser in the dental operatory to provide inhalational aromatherapy during the extraction procedure.
OTHERPlacebo AromatherapyDistilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.

Timeline

Start date
2025-11-20
Primary completion
2026-01-07
Completion
2026-01-07
First posted
2026-04-01
Last updated
2026-04-01

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT07506135. Inclusion in this directory is not an endorsement.