PDL Anesthesia Versus Local Infiltration

Overview

The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL injection was described by the majority of patients either as greater than local infiltration6, or as negligible or as a less painful injection compared with other injection techniques. The aim of this study was to evaluate the efficacy of and patients' subjective responses to the PDL injection technique as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth.

Full Title of Study: “Periodontal Ligament Injection Versus Routine Local Infiltration, for the Non-surgical Single Posterior Maxillary Permanent Tooth Extraction: Comparative Double Blinded Randomized Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2016

Detailed Description

Aim: The aim of this study was to evaluate the efficacy of and patients' subjective responses to the periodontal ligament (PDL) anesthetic injection as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth. Methods: All patients scheduled for non-surgical symmetrical maxillary posterior permanent teeth extraction in the Department of Oral and Maxillofacial Surgery (OMFS) at the University of Jordan Hospital, Amman, Jordan, over a-seven-month period, were invited to participate in this prospective randomized double blinded, split mouth study. Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) were used to describe the pain felt during injection and extraction, respectively. Statistical significance was based on probability values of <0.05 and measured using Chi-Square and Student-t tests, and Nonparametric Mann-Whitney and Kruskal-Wallis tests.

Interventions

  • Procedure: PDL anesthesia versus local infiltration
    • Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) was used to describe the pain felt during injection.

Arms, Groups and Cohorts

  • Experimental: primary periodontal ligament anesthesia
    • PDL anesthesia versus local infiltration
  • Active Comparator: local infiltration
    • PDL anesthesia versus local infiltration

Clinical Trial Outcome Measures

Primary Measures

  • the Visual Analogue Scale (VAS) scores for injections pain
    • Time Frame: 5 minutes
    • The VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high

Participating in This Clinical Trial

Inclusion Criteria

The inclusion criteria were: patients who were fit for surgery under LA (classified by the American Society of Anaesthesiologists (ASA) as ASA I-ASA III); patients exhibiting full understanding of given oral instructions; and bilateral symmetrical posterior maxillary permanent teeth referred for non-surgical extractions under LA. Exclusion Criteria:

Exclusion criteria were: the presence of acute dento-alveoalr infection; patients requiring conscious sedation or general anesthesia; patients unwilling to participate in the study; patients with ASA greater than III; patients on anti-inflammatory or recreational drugs; and patients requiring more than two additional injections in one or both sides for incomplete anesthesia.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Jordan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammad H Al-Shayyab, Associate Professor, Assisstant Dean, Principal Investigator – University of Jordan
  • Overall Official(s)
    • Mohammad H Al-Shayyab, Fellowship, Principal Investigator, The University of Jordan

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