Comparative evaluation of the effectiveness of a neuromodulation device and conventional topical anesthetic agent prior to local anesthesia administration in children: A randomised controlled clinical trial
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Assessment of pain and anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), and Respiratory Rate (analyzed manually)
Study Overview
Brief Summary
Pain in children during dental procedures can cause significant anxiety, leading to dental phobia and avoidance of necessary treatment. Local anesthesia (LA) is essential for pain management in pediatric dentistry but is often associated with fear due to the use of needles. This fear can lead to increased anxiety, abnormal physiological responses, and resistance to treatment.
Various methods have been explored to minimize pain during LA administration, including behavioral techniques, topical anesthetics, and advanced delivery systems like computerized injectors. Among these, topical anesthetics are widely used due to their ease of application and ability to reduce needle-related pain. However, they may have limitations such as delayed onset, unpleasant taste, or allergic reactions.
Neuromodulation devices, such as the Dental Pain Eraser, offer a promising alternative by delivering mild electrical impulses to block pain signals and stimulate natural pain relief. These devices have shown effectiveness in reducing pain and anxiety during various dental procedures, including orthodontic treatments and extractions. Compared to conventional transcutaneous electrical nerve stimulation (TENS) devices, which can be bulky and uncomfortable, portable neuromodulation devices provide a more patient-friendly approach.
This study aims to evaluate and compare the effectiveness of a neuromodulation device and a topical anesthetic agent in reducing pain and anxiety before local anesthesia administration in children undergoing primary teeth extraction. The findings could help establish a more comfortable and efficient pain management strategy in pediatric dentistry, reinforcing positive dental experiences.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1- Patients in ASA-I and ASA-II category.
- •2- Patients who are indicated for primary teeth extraction.
- •3- Patients in the 6-10 yrs of age group.
- •4- Children with Frankel Behaviour ratings 3 and 4.
Exclusion Criteria
- •1- Patients with known allergy to any component of local anesthesia.
- •2- Patients with special health care needs 3- Patients unwilling to be a part of this study.
Outcomes
Primary Outcomes
Assessment of pain and anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), and Respiratory Rate (analyzed manually)
Time Frame: At baseline, during needle insertion and local anesthesia deposition
Secondary Outcomes
- Assessment of pain & anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), & Respiratory Rate (analyzed manually)