Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth

NCT05115773 | Completed DMC

• 1 other identifier: 2019-TDU-DİŞF-0013
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection pain, the success of anesthesia, postoperative complications, and the subjects' preference was planned. This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78 subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent mandibular molar were included.

Conditions

Anesthesia, Local

Keywords

intraligamentary anesthesia; inferior alveolar nerve block; paediatric dentistry

Outcome Measures

Primary Outcomes (8)

• The measurements of dental pain using Visual Analogue Scale

  Subjective pain perception scores during the intervention using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)

  Immediately after the working with a low-speed rotary instrument on dentin

• The measurements of injection pain using Visual Analogue Scale

  Subjective pain perception scores after the local anesthetic injection using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)

  Immediately after the local anaesthetic injection

• Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.

  Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)

  Immediately after the working with a low-speed rotary instrument on dentin

• Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.

  Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)

  Immediately after the local anaesthetic injection

• Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin

  Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter

  Baseline and immediately after the working with a low-speed rotary instrument on dentin

• Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin

  Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter

  Baseline and immediately after the local anaesthetic injection

• Practitioner's assessment of patient pain-related comfort

  Practitioner's subjective records: cases who need additional mandibular anaesthesia, whose treatment is completed without a discomfort related to pain, who has a slight discomfort even though additional mandibular anaesthesia is not needed during the treatment

  Immediately after the dental treatment

• Rate of post-op complication

  Query the presence of post-op complications related to local anaesthesia

  Day after intervention

Secondary Outcomes (1)

• Evaluate the correlation between two self reported objective pain scales

  Immediately after the local anaesthetic injection

Study Arms (2)

Intraligamentary Anaesthesia

EXPERIMENTAL

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.

Procedure: Intraligamentary anaesthesia

Mandibular Anaesthesia

ACTIVE COMPARATOR

Before the restorative treatment of mandibular first molar, inferior alveolar nerve block will be provided using the direct standard method. The 27 gauge needle of a 2ml disposable plastic syringe (Ayset, Adana, Turkey) enters from the intersection of the internal oblique edge and the midline of the pterygomandibular raphe, and 1 ml of 4% articaine solution containing1:100,000 epinephrine (Ultracaine DS Forte ampul, Sanofi-Aventis GmbH, Almanya) will be injected slowly in 60 seconds. 15 minutes after the injection the anaesthesia of the lip/tongue will be checked by probing the labial mucosa of the ipsilateral canine tooth.

Procedure: Mandibular anaesthesia

Interventions

Intraligamentary anaesthesia PROCEDURE

one tooth anaesthesia by 2 or 4 points intraligamentary injection

Also known as: 2 or 4 points intraligamentary injection

Intraligamentary Anaesthesia

Mandibular anaesthesia PROCEDURE

Inferior alveolar nerve block by direct standart method

Also known as: Inferior alveolar nerve block

Mandibular Anaesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Study Officials

• Funda Çağırır Dindaroğlu, Asst. Prof.

  İzmir Katip Çelebi University Faculty of Dentistry

  STUDY DIRECTOR

• Ece Yılmaz, DDS

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization was performed by a computer-generated random sorting sequence
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: randomized controlled, single-blind, split-mouth clinical trial

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 10, 2021
• Study Start: February 25, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

TU (1)