NCT07352397

Brief Summary

Background: Dental anxiety and pain are common concerns in pediatric dentistry. These issues can lead to negative experiences for children and can make it difficult for them to cooperate during treatment. While medications can help manage these symptoms, it can also have side effects. This highlights the need for safe and effective complementary treatments. Aromatherapy, particularly with lavender and rosemary oils, has demonstrated anxiolytic and analgesic properties in different fields. However, their effect in helping children cope with dental anxiety and pain during procedures requiring local anesthesia has not yet been thoroughly studied. Purpose: This study aims to investigate the efficacy of inhaled lavender oil, rosemary oil, and their combination in reducing dental anxiety and pain in children receiving local anesthesia for extraction of lower primary molar

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety scores

    Venham scale will be used. it ranges from 0 (relaxed) to 5 (Child out of contact with the relaity of threat)

    up to 1 week

Secondary Outcomes (3)

  • Change in anxiety scores (by children)

    up to 1 week

  • Change in pain scores

    up to 1 week

  • Change in heart rate

    During procedure

Study Arms (4)

Group I

EXPERIMENTAL
Other: Lavender group

Group II

EXPERIMENTAL
Other: Rosemary group

Group III

EXPERIMENTAL
Other: Combination of both lavender and rosemary

Group IV

ACTIVE COMPARATOR
Other: No essential oils

Interventions

Children in this group would be inhaled 0.5 ml of prepared mixture (of Lavandula Angustifolia and Rosmarinus Officinalis + Sweet Almond carrier oil) on a cotton pad attached to the facial steamer .

Group III

Children in this group will be inhaled 0.5 ml of prepared mixture (of Lavandula Angustifolia+ Sweet Almond carrier oil ) on a cotton pad attached to the facial steamer .

Group I

Children in this group will be inhaled 0.5 ml of prepared mixture (of Rosmarinus Officinalis + Sweet Almond carrier oil ) on a cotton pad attached to the facial steamer

Group II

Children in this group will be inhaled 0.5 mL of the carrier oil (Sweet Almond ) on a cotton pad attached to the facial steamer .

Group IV

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Frankl behavioural rating score 2 or 3 during preoperative assessment.
  • Healthy children ASAI.
  • Children without a previous dental history.
  • Children presenting with at least one mandibular molar indicated for extraction. (43)
  • Completion of the written informed consent form by parents/guardian.

You may not qualify if:

  • Children with colds, asthma, and any other respiratory diseases.
  • Children who took NSAIDs or analgesic drugs in the last 8 hours before treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Central Study Contacts

Mayy Sharaf, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

January 20, 2026

Primary Completion

February 25, 2026

Study Completion

February 25, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations