Clinical trial NCT04947267: To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor
Official title: To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: LOCAL ANESTHESIA
Keywords: pulpal oxygen saturation
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.

Detailed description: BACKGROUND ' Local anesthesia is the foremost requirement of an efficient operative dental procedure to be executed in a pain free and calm environment. Local anesthesia is available in two forms: with vasoconstrictor and without vasoconstrictor. As vasoconstrictors adversely affect pulpal hemodynamics, this study aims to compare the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).

NULL HYPOTHESIS There is no difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.

ALTERNATE HYPOTHESIS There is a difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.

METHOD Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with the Nellcor- PM 10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.

STATISTICAL ANALYSIS The statistical package for social sciences version 21.0 is used for statistical analysis. Mean and standard deviation of the pulpal oxygen saturation levels for filled and unfilled teeth under the effect of 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine were recorded. Mixed Way ANOVA will be applied to discern if there is any difference in the pulpal oxygen saturation levels within and between the two groups. Post Hoc Tuckey was applied to identify whether the paired difference is present within groups or between the two groups.

Eligibility criteria: Inclusion Criteria:

* Medical status: healthy individuals with no current and past medical findings.
* Medications: no current medications.
* Both mature vital ipsilateral mandibular premolars:

  * Healthy premolar (ICDAS code 0)
  * Carious premolar (ICDAS code 4-6).
* Periapical status

  * Healthy premolar - Periapical Index. (Code 1).
  * Carious premolar - Periapical Index. (Code 1).
* Periodontal status

  * Healthy premolar - Classification of periodontal diseases and conditions (Code 0).
  * Carious premolar - Classification of periodontal diseases and conditions (Code 0).

Exclusion Criteria:

* Patients with oral and maxillofacial syndromes and anomalies.
* Pregnant and nursing mothers.
* Class V carious lesions (sensor of pulse oximeter was placed on intact buccal, lingual and cervical surfaces).
* Teeth with extracoronal restorations.
* Teeth with developmental defects and other anomalies.
* Dental trauma.
* Teeth with symptoms of irreversible pulpitis.

Primary outcomes:
measure: PULPAL OXYGEN SATURATION
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: AFSHAN AMJAD ALI, MSc
role: PRINCIPAL_INVESTIGATOR
References: