Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips

NCT07703410 | Not Yet Recruiting DMC

• 1 other identifier: SCD-OPER-2026-06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized split-mouth controlled clinical trial will compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips and conventional dental needle tips. Sixty adult patients requiring bilateral maxillary anterior infiltration anesthesia will receive injections with both needle types in a randomized order. Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS). The study aims to determine whether the Transcodent needle tip reduces injection-related pain compared with a conventional needle tip, thereby improving patient comfort during routine dental procedures.

Conditions

Pain; Post Endodontic Pain

Keywords

Pain; anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Score During Anterior Maxillary Infiltration Injection

  Pain perception measured using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. Pain scores will be recorded immediately after administration of infiltration anesthesia using either a Transcodent

  Immediately after each injection

Study Arms (2)

Sequence A: Transcodent Needle First

EXPERIMENTAL

Participants receive anterior maxillary infiltration anesthesia using a Transcodent painless needle tip with a three-edge lancet grinding bevel and silicone-coated cannula. Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).

Device: Transcodent Painless Needle Tip; Device: Conventional Dental Needle Tip

Sequence B: Conventional Needle First

EXPERIMENTAL

Participants receive anterior maxillary infiltration anesthesia using a conventional dental needle tip. Pain is assessed immediately after injection using a 100-mm Visual Analog Scale (VAS).

Device: Transcodent Painless Needle Tip; Device: Conventional Dental Needle Tip

Interventions

Transcodent Painless Needle Tip DEVICE

A dental injection needle with a three-edge lancet grinding bevel and silicone-coated cannula designed to reduce tissue resistance and injection pain during anterior maxillary infiltration anesthesia.

Sequence A: Transcodent Needle First; Sequence B: Conventional Needle First

Conventional Dental Needle Tip DEVICE

A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.

Sequence A: Transcodent Needle First; Sequence B: Conventional Needle First

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 years. Patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment.
• Patients undergoing endodontic procedures involving maxillary canines or premolars.
• Presence of healthy maxillary teeth on both sides suitable for infiltration anesthesia.
• Individuals with no systemic disease or neurological disorder affecting pain perception.
• Ability to understand the study procedures and provide written informed consent.
• Both male and female participants.

You may not qualify if:

• Pregnant or lactating women. Use of analgesics, sedatives, or other pain-modifying medications within the previous 12 hours.
• Known allergy or hypersensitivity to local anesthetics, benzocaine, lidocaine, or epinephrine.
• Presence of active infection, inflammation, swelling, or pathology at the injection site.
• Severe dental anxiety, needle phobia, or inability to cooperate with study procedures.
• Individuals unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Saidu College of Dentistry: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Azra Umar

  Saidu College of Dentistry, Swat, Paksitan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azra Umar, BDS

CONTACT

+92 331 8080135; drumarhussain@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Rationale: The operator administering the injections knows which needle is being used. The protocol does not specify participant blinding or blinded outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized split-mouth crossover clinical trial in which each participant receives both interventions. One maxillary anterior site receives infiltration anesthesia using a Transcodent painless needle tip and the contralateral site receives infiltration anesthesia using a conventional needle tip. The order of needle type and injection site is randomized. Each participant serves as his or her own control.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 14, 2026
• Study Start: June 23, 2026
• Primary Completion: June 23, 2026
• Study Completion: July 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share