PainNCT07703410
Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips
A study testing Transcodent Painless Needle Tip and Conventional Dental Needle Tip in people with Pain and Post Endodontic Pain, run by Saidu College of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Post Endodontic Pain
- What is being tested?
- Transcodent Painless Needle Tip and Conventional Dental Needle Tip
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Saidu Collage of Dentistry, Saidu Sharif , Swat
Mingora Swat, 19200
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Post Endodontic Pain
- Being tested
- Transcodent Painless Needle Tip, Conventional Dental Needle Tip
- Keywords
- Pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcodent Painless Needle TipDevice
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.
Conventional Dental Needle TipDevice
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Transcodent Painless Needle Tip; Device: Conventional Dental Needle Tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion18 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saidu College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azra Umar, Principal investigator, Saidu College of Dentistry, Swat, Paksitan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703410
- Sponsor's protocol ID
- SCD-OPER-2026-06
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07703410
- Acronym / sponsor ID
- SCD-OPER-2026-06
- Conditions
- Pain, Post Endodontic Pain
- Keywords
- Pain, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saidu College of DentistryUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Transcodent Needle First | Experimental | Device: Transcodent Painless Needle Tip, Device: Conventional Dental Needle TipParticipants 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). |
| Sequence B: Conventional Needle First | Experimental | Device: Transcodent Painless Needle Tip, Device: Conventional Dental Needle TipParticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcodent Painless Needle TipA 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 | Sequence A: Transcodent Needle First, Sequence B: Conventional Needle First |
| Conventional Dental Needle TipA standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia. | Device | Sequence A: Transcodent Needle First, Sequence B: Conventional Needle First |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azra Umar principal investigator
Saidu College of Dentistry, Swat, Paksitan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcodent Painless Needle Tip and Conventional Dental Needle Tip in people with Pain and Post Endodontic Pain, run by Saidu College of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azra Umar, BDS (+92 331 8080135, drumarhussain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score During Anterior Maxillary Infiltration Injection (time frame: Immediately after each injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.