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Jämförelse av digital intraosseös och manuell intraligamentär anestesi hos barn

3 november 2026 uppdaterad av: Funda Cagırır Dindaroglu, Izmir Katip Celebi University

Jämförelse av digital intraossal och manuell intraligamentär anestesi hos barn: En randomiserad kontrollerad studie

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Studieöversikt

Detaljerad beskrivning

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.

The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.

Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.

Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

Studietyp

Interventionell

Inskrivning (Beräknad)

78

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Funda Çağırır Dindaroğlu, Study Director
  • Telefonnummer: +905363465653
  • E-post: fundacagirir@gmail.com

Studera Kontakt Backup

  • Namn: Buse Düzgün, Principal Investigator
  • Telefonnummer: +905073022366
  • E-post: busedzgn@hotmail.com

Studieorter

    • Cigli
      • Izmir, Cigli, Turkiet (Türkiye), 35000
        • Rekrytering
        • Izmir Katip Çelebi University Faculty of Dentistry
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år till 12 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Subjects with American Society of Anesthesiologists score I (ASA I)
  • Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
  • Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars
  • Subjects whose plaque index score of 0 (no plaque) and 1
  • Subjects whose gingival index score of 0

Exclusion Criteria:

  • Allergic to the local anesthetics or sulfites
  • Subjects with cholinesterase deficiency
  • Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
  • Subjects who need to use sedatives or other medications during dental procedures

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intraligamentary Anaesthesia

Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

Andra namn:
  • 2 eller 4 poäng intraligamentär injektion
Aktiv komparator: Digital Intraosseous Anesthesia

For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth.

To maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.

Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain intensity using Visual Analog Scale (VAS)
Tidsram: During injection and during dental procedure

Subjective pain perception measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst possible pain). Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Pain intensity using Wong-Baker FACES Pain Rating Scale
Tidsram: During injection and during dental procedure

Subjective pain perception measured using the Wong-Baker FACES Pain Rating Scale (0-10), where higher scores indicate greater pain. Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Heart rate changes
Tidsram: Baseline, during injection and during dental procedure

Heart rate measured using a pulse oximeter (beats per minute, bpm).

Baseline, during injection and during dental procedure
Oxygen saturation (SpO₂) changes
Tidsram: Baseline, during injection and during dental procedure

Arterial oxygen saturation measured using a pulse oximeter (%).

Baseline, during injection and during dental procedure
Practitioner's assessment of anesthesia success
Tidsram: Immediately after dental treatment

Clinician-reported outcomes including need for additional anesthesia, presence of discomfort during treatment, and successful completion of the procedure without pain.

Immediately after dental treatment
Postoperative complications
Tidsram: Day 1 after intervention

Presence of postoperative complications related to local anesthesia.

Day 1 after intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation between pain scores measured by VAS and Wong-Baker FACES scale
Tidsram: Immediately after injection

Correlation between pain scores measured using the Visual Analog Scale (VAS, 0-10) and Wong-Baker FACES Pain Rating Scale (0-10) following local anesthetic injection in children aged 6-12 years. Higher scores indicate greater pain intensity.

Immediately after injection

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

24 mars 2026

Först inskickad som uppfyllde QC-kriterierna

5 april 2026

Första postat (Faktisk)

13 april 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

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