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

NCT ID: NCT05115773

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2020-08-31

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.

Detailed Description

First, the subjects who met the inclusion criteria in the study were included in 2 study groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and radiographic evaluation criteria. Two different anesthesia techniques were applied to the right / left permanent first molar teeth of the patients included in the study, with an interval of one week. The subjects have been divided into two groups as 39 subjects were Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2 received mandibular anesthesia in the first session. The pain perception rates of the patients during the injection and treatment phases were recorded subjectively using a visual analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen saturation were determined as the physiological parameters. The quality of anesthesia and success were evaluated by the operation at the end of each visit. Complications (pain, raised teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were explained to the patients after anesthesia. They were asked to take note of the complications they encountered. Postoperative complications were recorded by calling the cases 1 day after the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient was asked and recorded.

Conditions

Anesthesia, Local

Keywords

intraligamentary anesthesia; inferior alveolar nerve block; paediatric dentistry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraligamentary anaesthesia

Intervention Type: PROCEDURE

one tooth anaesthesia by 2 or 4 points intraligamentary injection

Mandibular Anaesthesia

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.

Group Type: ACTIVE_COMPARATOR

Mandibular anaesthesia

Intervention Type: PROCEDURE

Inferior alveolar nerve block by direct standart method

Interventions

Intraligamentary anaesthesia

one tooth anaesthesia by 2 or 4 points intraligamentary injection

Intervention Type: PROCEDURE

Mandibular anaesthesia

Inferior alveolar nerve block by direct standart method

Intervention Type: PROCEDURE

Other Intervention Names

2 or 4 points intraligamentary injection; Inferior alveolar nerve block

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Funda Cagırır Dindaroglu

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Funda Çağırır Dindaroğlu, Asst. Prof.

Role: STUDY_DIRECTOR

İzmir Katip Çelebi University Faculty of Dentistry

Ece Yılmaz, DDS

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

Izmir Katip Celebi University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019-TDU-DİŞF-0013

Identifier Type: -

Identifier Source: org_study_id