- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173898
PDL Anesthesia Versus Local Infiltration (PDL)
Periodontal Ligament Injection Versus Routine Local Infiltration, for the Non-surgical Single Posterior Maxillary Permanent Tooth Extraction: Comparative Double Blinded Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: primary periodontal ligament anesthesia
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.
|
Active Comparator: local infiltration
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammad H Al-Shayyab, Fellowship, The university of Jordan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RF: 10/2015/15791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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