Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques

NCT05724862 | Unknown

• 1 other identifier: 25-11-2022
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Besides, the level of anxiety was established as one of the most crucial predictors of dental anesthesia level. Techniques and equipment such as topical anesthetic, cold spray, applying pressure, vibratory devices, distraction techniques, sedation medications, have been developed and utilized to reduce pain or fear of dental injections or increase the efficacy of anesthesia. However it is the sight and sensation of a needle that was found by almost 25% of patients to be extremely anxiety provoking stimuli in a survey to determine what dental patients truly fear. Therefore, Needleless devices that were developed to provide anesthesia without injections would reduce patients' apprehension and anxiety levels resulting in a profound anesthesia for a proper duration of time

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Intra operative pain

  Using NRS score

  Up to One hour

Secondary Outcomes (1)

• Onset of pulpal anaesthesia

  Up to Ten minutes

Study Arms (2)

Needle-less jet anaesthesia

EXPERIMENTAL

Infiltration anaesthesia without needle

Device: Needle-less jet anaesthesia

Conventional injection anaesthesia

ACTIVE COMPARATOR

Regular infiltration anaesthesia

Device: Conventional Injection Anesthesia

Interventions

Needle-less jet anaesthesia DEVICE

Infiltration anesthesia without needle depending on injection pressure

Needle-less jet anaesthesia

Conventional Injection Anesthesia DEVICE

Regular Infiltration local anesthesia

Conventional injection anaesthesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range 18-50
• Males and females
• Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
• Patients accepting to participate in the trial
• Patients who can understand pain scale and can sign the informed consent
• Mature maxillary molars with symptomatic irreversible pulpitis

You may not qualify if:

• Medically compromised patients having significant systemic disorders (ASA III or IV).
• Pregnant females
• Teeth with necrotic pulps
• Non-restorable or periodontally hopeless teeth
• Patients on analgesic or anti-inflammatory drugs 12 hours prior to treatment
• Patients allergic to any of the components of the anesthetic solution

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Shaimaa I Bakry

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nader W Ramsis

CONTACT

01225321044; nader.wadie@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: February 13, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share