Dental AnxietyNCT07506135
Effect of Aromatherapy on Pain and Anxiety During Orthodontic Extraction of Maxillary Premolars.
A study testing Lemongrass Aromatherapy in people with Dental Anxiety and Pain, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain
- What is being tested?
- Lemongrass Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- 20 Nov 2025to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)?
Read the 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
- Dental Anxiety, Pain
- Being tested
- Lemongrass Aromatherapy, Placebo Aromatherapy
- Keywords
- Aromatherapy, Lemongrass essential oil, Orthodontic extraction, Maxillary premolar, Dental anxiety, Split-mouth trial
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemongrass AromatherapyOther
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 AromatherapyOther
Distilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 24 hours post-procedure
Secondary outcomes (5)
Systolic Blood Pressure
Systolic blood pressure measured in millimeters of mercury (mmHg)90-140 mmHg. Higher values may indicate increased physiological stress.(worse outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start20 Nov 2025
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Virendra Singh, MDS, Study director, Postgraduate Institute of Dental Sciences Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506135
- Sponsor's protocol ID
- Rashmi Bawane
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aromatherapy in Orthodontic Extraction of Maxillary Premolars: A Randomized Controlled Split-Mouth Clinical Trial.
- ClinicalTrials.gov ID
- NCT07506135
- Acronym / sponsor ID
- Rashmi Bawane
- Conditions
- Dental Anxiety, Pain
- Keywords
- Aromatherapy, Lemongrass essential oil, Orthodontic extraction, Maxillary premolar, Dental anxiety, Split-mouth trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy (Lemongrass Essential Oil) | Experimental | Other: Lemongrass AromatherapyParticipants 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. |
| Placebo Aromatherapy (Distilled Water Diffusion) | Placebo comparator | Other: Placebo AromatherapyParticipants 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. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemongrass AromatherapyLemongrass essential oil diluted in water and administered using an electric diffuser in the dental operatory to provide inhalational aromatherapy during the extraction procedure. | Other | Aromatherapy (Lemongrass Essential Oil) |
| Placebo AromatherapyDistilled water administered using an electric diffuser in the dental operatory to mimic aromatherapy exposure without active essential oil. | Other | Placebo Aromatherapy (Distilled Water Diffusion) |
Primary outcome
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).
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).
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).
5 secondary outcomes
Systolic Blood Pressure
Time frame: Baseline (pre-procedure), intra-procedural (during local anesthesia administration), and immediately post-procedure (within 30 minutes after extraction)
Diastolic Blood Pressure
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Heart Rate
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Respiratory Rate
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Oxygen Saturation
Time frame: Baseline (pre-procedure), intra-procedural, and immediately post-procedure (within 30 minutes after extraction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Virendra Singh, MDS study director
Postgraduate Institute of Dental Sciences Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemongrass Aromatherapy in people with Dental Anxiety and Pain, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.