PDL Anesthesia Versus Local Infiltration

NCT03173898 | Completed DMC

• 1 other identifier: RF: 10/2015/15791
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia, Local

Keywords

PDL Injection; Infiltration; Anesthesia; Extraction

Outcome Measures

Primary Outcomes (1)

• the Visual Analogue Scale (VAS) scores for injections pain

  The VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high

  5 minutes

Study Arms (2)

primary periodontal ligament anesthesia

EXPERIMENTAL

PDL anesthesia versus local infiltration

Procedure: PDL anesthesia versus local infiltration

local infiltration

ACTIVE COMPARATOR

PDL anesthesia versus local infiltration

Procedure: PDL anesthesia versus local infiltration

Interventions

PDL anesthesia versus local infiltration 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; primary periodontal ligament anesthesia

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Jordan: lead

Study Officials

• Mohammad H Al-Shayyab, Fellowship

  The University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Assisstant Dean, Principal Investigator

Model Details: a prospective randomized double blinded, split mouth study

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 2, 2017
• Study Start: July 6, 2015
• Primary Completion: January 31, 2016
• Study Completion: January 31, 2016
• Last Updated: June 5, 2017

Record last verified: 2017-05