Pain During Infiltration Injection in Anterior Maxillary Region by Transcodent Painless Needle Tips Versus Regular Needle Tips
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Azra Umar, BDS
- Telefonnummer: +92 331 8080135
- E-mail: drumarhussain@gmail.com
Studiesteder
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Mingora Swat, Pakistan, 19200
- Saidu Collage of Dentistry, Saidu Sharif , Swat
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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).
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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.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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Eksperimentel: 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).
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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.
A standard dental injection needle with a conventional bevel design used for anterior maxillary infiltration anesthesia.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Score During Anterior Maxillary Infiltration Injection
Tidsramme: Immediately after each injection
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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
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Immediately after each injection
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Azra Umar, Saidu College of Dentistry, Swat, Paksitan
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCD-OPER-2026-06
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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