Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment

September 18, 2020 updated by: University Medicine Greifswald

Randomized Clinical Trial on the Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment

Objective: To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth.

Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males, 33 females) patients scheduled for dental treatment of mandibular posterior teeth, were randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received the conventional IANB. Our primary outcome was to assess pain during the injection as well as pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS) from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours postoperative complications were our Secondary outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MATERIALS AND METHODS This prospective randomized comparative clinical trial was conducted in the integrated clinical course in the dental school of the University of Greifswald, Germany after the approval of the local ethics committee of the medical faculty in Greifswald (No. BB 174/18) in a period from December 2018 to June 2019. The sample size calculation using "G*power version 3.1" (Heinrich-Heine-University / Germany) was based on the following estimates: T-test for means (difference between two independent means), effect size 0.7, α error 0.05 and power (1-ß error) 0.9. It resulted in a samples size of 36 patients in each of the two groups (IANB & ILA).

Inclusion and Exclusion Criteria The patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia were recruited with an age range of 18 to 50 years. Patients were not included if they had a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology. Also patients with a systemic disease requiring special considerations during their dental treatment or patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite) were excluded.

Clinical Treatment and Outcome Computer-generated randomization technique was applied to allocate the participants to one of the both study groups (ILA vs. IANB). The intensity of pain as well as stress during the injection of the local anesthesia and during the dental procedure was assessed by using the Numeric Rating Scale (NRS 0-10). The anesthesia was performed by the clinical instructors of the course being dental practitioners (GDPs) or by dental students in the 4th and 5th academic year in the integrated clinical course in the dental school of the University of Greifswald and recorded as dentist or student. The distributions of different experience level of clinical instructors, dental students in 4th and 5th year were considered. For the inferior alveolar nerve block, the patient was placed comfortably in a supine position on the dental chair. The start of the anesthetic procedure was done without using topical anesthesia. The IANB injection was administered with cannulas of 38 mm in length and a gauge of 0.4 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). The patients were anesthetized with Ultracain DS Forte 1:100.00 (Sanofi Aventis, Germany), the active ingredient being articaine in 1.7 ml ampules (1 ml equal to 40 mg articaine hydrochloride and 0.012 mg epinephrine hydrochloride, which is included as a vasoconstrictor). Once the bone was contacted, 1.5 ml of anesthetic solution was injected slowly. Subsequently the needle was detached for approximately 1 cm and an addition of 0.3-0.5 ml of local anesthetic solution was injected to anesthetize the lingual nerve.

For the intraligamentary anesthesia, three different syringe systems were used with randomized selection: Softjet syringe (Henke-Sass Wolf, Tuttlingen, Germany), Citojet syringe (Sopira, Heraeus Kulzer GmbH Hanau, Germany), Ultrajet syringe (Sanofi-Aventis, Frankfurt am Main, Germany). The patients were also placed in a supine position and the dentist administered the ILA injection without using topical anesthesia with cannulas of 12 mm in length and a gauge of 0.30 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). Also, Ultracain DS Forte 1:100.000 (Sanofi Aventis, Germany) was used from 1.7 ml ampules. The needle was navigated through the gingival sulcus with the bevel towards the alveolar bone and away from the root surface, at an angle of 30°-40° to the long axis of the tooth and 2- 3 mm into the periodontal ligament space between root and alveolar bone. For each root, 0.2 ml of local anesthetic was injected over at least 20 seconds according to Endo et al. (2008) as well as Bender and Taubenheim (2014).

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17487
        • University Medicine of Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia

Exclusion Criteria:

  • Patients with a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology
  • Patients with a systemic disease requiring special considerations during their dental treatment
  • Patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional inferior alveolar nerve block (IANB)
37 patients received Inferior Alveolar Nerve Block (IANB) for dental treatment of mandibular posterior teeth.
Other: local anaesthetic techniques
The patients were anesthetized with two different local anaesthetic techniques.
EXPERIMENTAL: Intraligamentary Anesthesia (ILA)
35 patients received Intraligamentary Anesthesia (ILA) for dental treatment of mandibular posterior teeth.
Other: local anaesthetic techniques
The patients were anesthetized with two different local anaesthetic techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain during the injection
Time Frame: immediately after the injection of LA
The intensity of pain during the injection of the LA to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
immediately after the injection of LA
The intensity of pain during the dental treatment
Time Frame: immediately after the dental treatment
The intensity of pain during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
immediately after the dental treatment
The intensity of stress (discomfort)
Time Frame: immediately after the dental treatment
The intensity of stress during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no discomfortable at all and 10 representing the maximal discomfortable very imaginable) is a valid instrument to measure stress (discomfort)
immediately after the dental treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 24 hours
Recording any postoperative complications which could be occurred (Nerve injury or any other temporary irritations like the pain at the site of injection, signs of intravascular injection, lip-bit injury)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Study Director: Christian splieth, PHD, University Medicine of Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

June 15, 2019

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB 174/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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