Pain, Post Endodontic Pain
Conditions
Keywords
Pain, anxiety
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.
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.
Interventions
DEVICETranscodent 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.
DEVICEConventional Dental Needle Tip
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
Sponsors
Saidu College of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Rationale: The operator administering the injections knows which needle is being used. The protocol does not specify participant blinding or blinded outcome assessment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score During Anterior Maxillary Infiltration Injection | 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 |
Countries
Pakistan
Contacts
CONTACTAzra Umar, BDS
PRINCIPAL_INVESTIGATORAzra Umar
Saidu College of Dentistry, Swat, Paksitan
Outcome results
None listed