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

September 11, 2026 updated by: Saidu College of Dentistry

Comparison of Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips: a Split-mouth Controlled Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized split-mouth controlled clinical trial aims to compare pain experienced during anterior maxillary infiltration anesthesia using Transcodent painless needle tips versus conventional dental needle tips. Dental injection pain is a common source of anxiety and may negatively affect patient acceptance of dental treatment. Recent advances in needle design, including the three-edge lancet grinding bevel and silicone-coated cannula of the Transcodent needle, have been developed to reduce tissue resistance during penetration and improve patient comfort.

A total of 60 adult patients requiring bilateral maxillary anterior infiltration anesthesia for dental treatment will be recruited from the Department of Operative Dentistry, Saidu College of Dentistry, Swat. Eligible participants will receive two supraperiosteal injections, one with a Transcodent painless needle tip and one with a conventional needle tip, on opposite sides of the maxillary arch. The order of needle use and injection site will be randomized using a balanced block randomization method. Prior to injection, 20% benzocaine topical anesthetic gel will be applied for two minutes. Each injection will consist of 0.9 mL of 2% lidocaine with 1:100,000 epinephrine administered over 30 seconds by the same operator.

Pain perception will be assessed immediately after each injection using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. The primary outcome is the difference in mean VAS pain scores between Transcodent and conventional needle tips. Data will be analyzed using paired statistical methods appropriate for the distribution of the data.

The findings of this study will provide local evidence regarding the effectiveness of Transcodent painless needle tips in reducing injection-related pain during maxillary infiltration anesthesia and may contribute to improving patient comfort and reducing dental anxiety during routine dental procedures.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Mingora Swat, Pakistan, 19200
        • Saidu Collage of Dentistry, Saidu Sharif , Swat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A: Transcodent Needle First
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
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.
Device: Conventional Dental Needle Tip
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
Experimental: Sequence B: Conventional Needle First
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
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.
Device: Conventional Dental Needle Tip
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score During Anterior Maxillary Infiltration Injection
Time Frame: Immediately after each 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saidu College of Dentistry

Investigators

  • Principal Investigator: Azra Umar, Saidu College of Dentistry, Swat, Paksitan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCD-OPER-2026-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during this study will not be made publicly available because of confidentiality and privacy considerations. De-identified aggregate study results will be reported in scientific publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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