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Clinical Trials/CTRI/2024/06/069004
CTRI/2024/06/069004CompletedPhase 3 4

Neuromodulation As An Alternative To Local Anaesthesia Injections In Paediatric Patients With MIH- A Split Mouth Study

ITS Dental college hospital and research centre1 site in 1 country10 target enrollmentStarted: June 25, 2024Last updated:

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

Sponsor
ITS Dental college hospital and research centre
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Bhawna Saxena

I.T.S Dental College Hospital and Research Centre

Study Sites (1)

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