A randomized clinical trial study of the effect of lavender and clove herbal topical anesthetics compared to benzocaine on dental injection pain in children

Many researchers have studied the effect of using topical anesthetic agents at the injection site for pain relief; however, non pharmacological methods are still under investigation, and there remains an unexplored and emerging research area with very limited studies. Since no study has compared these two substances, this study is designed and conducted to compare the effect of topical herbal anesthesia of lavender and clove on the level of pain during dental injection in children.

A crossover study involving at least 24 children requires three sessions of maxillary posterior infiltration anesthesia. Randomization is performed using blocks of six, with triple blinding. Three topical anesthetics—20% benzocaine, 100% lavender gel, and 100% clove gel—are applied for 2 minutes prior to injection of 2% lidocaine with epinephrine. Pain intensity during injection is assessed using the FLACC scale, and post-injection pain is measured using the FPS-R scale.

School of Dentistry, Tehran University of Medical Sciences

Inclusion: Healthy children (ASA I–II), cooperative behavior (Frankl 3 or 4), no recent medication (past 12h), requiring three maxillary infiltration sessions, with verbal communication ability. Exclusion: Systemic disease, anxiety/phobia, active infection, injection site pathology, behavioral/learning disorders, prior dental treatment, or allergy history.

Topical anesthesia prior to injection is performed using: 1. 20% benzocaine topical anesthetic, 2. 100% lavender topical gel, 3. 100% clove topical gel.

FPS-R-based comparison of topical anesthesia effects in clove, lavender, and control (benzocaine) groups. - FLACC-based comparison of topical anesthesia effects in clove, lavender, and control (benzocaine) groups.

Given the six possible sequential models for the interventions, randomization of the samples is performed using blocks of six and with the aid of Excel software. The randomization process is conducted by the study’s methodology consultant, and the other researchers are blinded to the allocation sequence. Once the intervention order is determined, the allocation for each patient is placed sequentially in sealed, numbered envelopes. During the intervention phase, these envelopes are opened in order, and the interventions are carried out accordingly.

Blinding in the study is implemented through three methods: 1) The three topical gels are made to appear identical, 2) The operator is unaware of the order in which the gels are applied, 3) The evaluator is unaware of the order in which the gels are applied.

All data may be shared, provided that individuals have been properly de-identified.

Access to the data will commence two months following the publication of the results.

Researchers working at academic and research institutions

Data may be used for future research in dental science without restriction

Alavi137516.ha@gmail.com

The requester must submit their application via the platform or email. After initial review and approval, a confidentiality agreement will be sent. Once the signed form is received, the data will be prepared and delivered. Estimated time to receive the files: 2 to 4 weeks, depending on data volume and number of requests.