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PDL Anesthesia Versus Local Infiltration

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03173898
Acronym
PDL
Enrollment
55
Registered
2017-06-02
Start date
2015-07-06
Completion date
2016-01-31
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Keywords

PDL Injection; Infiltration; Anesthesia; Extraction

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.

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

PROCEDUREPDL 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.

Sponsors

University of Jordan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

a prospective randomized double blinded, split mouth study

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the Visual Analogue Scale (VAS) scores for injections pain5 minutesThe VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026