PDL Anesthesia Versus Local Infiltration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-06

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a prospective randomized double blinded, split mouth study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The method of anesthesia used for the left or right sides was blinded to the patient and determined randomly by the same surgeon (MA) who was not involved in the extraction. the extraction procedure was randomly commenced by the same resident who was blinded to the anesthetic technique administered randomly by the surgeon.participiants were also blinded to the type of technique applied on each side.

Study Groups

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primary periodontal ligament anesthesia

PDL anesthesia versus local infiltration

Group Type EXPERIMENTAL

PDL anesthesia versus local infiltration

Intervention Type PROCEDURE

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.

local infiltration

PDL anesthesia versus local infiltration

Group Type ACTIVE_COMPARATOR

PDL anesthesia versus local infiltration

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes