Neuromodulation As An Alternative To Local Anaesthesia Injections In Paediatric Patients With MIH- A Split Mouth Study
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Effectiveness of neuromodulation as an anesthetic agent
Study Overview
Brief Summary
In pediatric dentistry, pain and anxiety due to injections or local anesthetics play a significant role in the development of negative behaviors and pose challenges in the management and treatment of young patients. This issue is further complicated by developmental defects like Molar Incisor Hypomineralization (MIH), which makes achieving effective anesthesia particularly difficult due to high tooth hypersensitivity. These challenges necessitate continuous research into alternative anesthesia and pain management modalities for MIH.
Transcutaneous Electrical Nerve Stimulation (TENS) or neuromodulation has shown promise in providing dental anesthesia or serving as an adjunct to local anesthesia. However, conventional devices using electric pads can exacerbate anxiety. Neuromodulation, based on the gate control theory and neuropeptide release, offers a potential solution. It can enhance or replace local anesthesia, reducing the need for repeated anesthetic injections and minimizing needle prick anxiety by either decreasing the sensation of the prick or eliminating the need for needle anesthesia altogether. This approach aims to deliver a more comfortable and pain-free dental experience for children with MIH.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with MIH with Bilateral Molars which are indicated for pulpotomy
- •FR Behavior rating 3 & 4 3.
Exclusion Criteria
- •1.Known neurological disorders.
- •2.Allergies to local anesthetics.
- •3.Contraindications to neuromodulation.
Outcomes
Primary Outcomes
Effectiveness of neuromodulation as an anesthetic agent
Time Frame: Pain- | 1. At baseline | 2. During Procedure | 3. After Procedure
Comparative evaluation of neuromodulation and local anesthesia injection
Time Frame: Pain- | 1. At baseline | 2. During Procedure | 3. After Procedure
Secondary Outcomes
- Patient acceptance & preference(1. Immediately after treatment)
Investigators
Dr Bhawna Saxena
I.T.S Dental College Hospital and Research Centre
