Checking the painless efficacy of vibrating device attached to syringe in patients undergoing tooth removal with premolar on both the sides of upper jaw

Not yet recruiting

• Conditions: Orthodontic Extraction

• Registration Number: CTRI/2020/04/024923
• Lead Sponsor: Jui Shekhar Karmarkar

Brief Summary

Pain is the most common cause of dentalanxiety,

Injecting effective local anesthesia is themost important pillar to alleviate pain.

In maxilla, palatal nerve blocks are mostpainful blocks as compare to infraorbital and posterior superior alveolar nerveblocks.

To overcome these pain of  injection many newer technologies have beendeveloped like Accupal  and Dentalvibe .

These devices had certain disadvantages withrespect to cost and portablility .

In order to overcome limitation newer devicecalled vibraject was introduced for delivering local anesthesia.

Vibraject is small vibrating device which hascontrol knob at its back that helps in vibrations and it makes a ’hum’ soundalong with vibrations. It is attached to conventional syringe with the help ofclip brackets which are autoclavable  which avoids cross contamination.

Its mode of action is that,

vibraject causes vibrations once the controlknob is rotated clockwise ,these vibrations are transferred to needle whichmask the pain while needle insertion and solution deposition , moreover that itmakes ’ Humm ’ sound which diverts patients mind .

Its mechanismof action is based on Gate Control Theory,

In 1965, Ronald Melzack and Charles Patrick(Pat) Wall ([Melzack](https://www.physiology.org/doi/full/10.1152/jn.00457.2012) [and Wall 1965](https://www.physiology.org/doi/full/10.1152/jn.00457.2012)) proposed the Gate Control Theory of Pain.

There are nociceptors (pain fibers-small) and(touch,pressure and vibration) fibers-large , these fibers synapse in two different regions within the dorsal horn ofthe spinal cord: cells in the substantia gelatinosa and the “transmissionâ€cells.

They proposed that the gate in the spinal cordis the substantia gelatinosa in the dorsal horn which modulates thetransmission of sensory information from the primary afferent neurons totransmission cells in the spinal cord.

Large-fiber activity inhibits (or closes) thegate, whereas small-fiber activity facilitates (or opens) the gate.

This mechanism of action helps in alleviatingpain .

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-05
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Patient requiring bilateral maxillary premolar extractions for orthodontic purpose.

Exclusion Criteria

• Patients with known allergy to local anesthetic agent.
• Mentally challenged patients.
• patients with any systemic disease.
• Patients not willing to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of vibraject injection technique while giving infra-orbital and greater palatine nerve block.	After acquiring all samples

Secondary Outcome Measures

Name	Time	Method
To evaluate Pain perception by Vibraject Injection technique while giving Infra-orbital and Greater palatine nerve block	During penetration of needle and during deposition of LA solution
To evaluate Pain perception by Conventional Injection technique while giving Infra-orbital and Greater palatine nerve block	During needle penetration and during deposition of LA solution
To compare pain perception between Vibraject Injection Technique and Conventional Injection Technique	after collection of all samples
To evaluate effectiveness of anesthesia by assessing pain during extraction.	During extraction

Trial Locations

Locations (1)

V.S.P.M Dental college and Research Center; 🇮🇳 Nagpur, MAHARASHTRA, India

V.S.P.M Dental college and Research Center

🇮🇳Nagpur, MAHARASHTRA, India

Jui Karmarkar

Principal investigator

7066620270

juikarmarkar14@gmail.com