Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration

Comparison of The Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration Using 4% Articaine During Extraction of Primary Maxillary Molar Teeth: A Randomized Controlled Trial Split Mouth Design Study

Everyday practice in dentistry is based on giving the painless injection and achieving adequate local anesthesia. Various techniques of reducing injection pain in children can be broadly categorized as psychological and physical. The psychological approach includes behavior management techniques, physical means and other recent techniques such as computer controlled anesthesia, electronic dental anesthesia, and so forth. However, none of these techniques have been successful in eliminating pain, fear and anxiety in children.

Direct palatal injection technique is difficult to administer without significant pain or discomfort since there is little tissue space at these sites between the mucosa and the underlying periosteum. Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.

The desirable method to evade pain during palatal injection is just not to have one.

Maxillary molars removal without palatal or multiple injections is possible due to relatively thin porous bone of posterior buccal maxilla that facilitates the diffusion of local anesthetic.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local
• Intervention / Treatment: Other: Single buccal infiltration

Detailed Description

The provision of intraoral palatal anesthesia can be potentially more painful for the patient when compared to other sites of the oral cavity, as palatal tissues are tightly bound to the hard palate with limited tissue space between it and the periosteum . As the injection is given, pressure builds up within the palatal tissues causing pain.

Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.

The desirable method to evade pain during palatal injection is just not to have one. So studies was made to evaluate the single buccal injection and its efficiency during extraction of maxillary teeth. The relatively thin porous bone of posterior buccal maxilla facilitates the diffusion of local anesthetic,as well as articaine can diffuse through soft and hard tissues more reliably than other LA so that maxillary buccal infiltration of articaine provides palatal soft tissue anesthesia.Therefore single injection eliminates the need for multiple painful injections.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children from 6 to 9 years of age requiring extraction in two different quadrants in maxillary arch.

  • Children who demonstrate positive or definitely positive behavior during pretreatment evaluation ranking 3 or 4 in the Frankl scale.

    • Rating 3: Positive Acceptance of treatment; at times cautious; willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
    • Rating 4 :Definitely positive Good rapport with the dentists interested in the dental procedures, laughing and enjoying.
  • Child must give assent prior to participation, as well as parental informed written consent.

Exclusion Criteria:

• Medically and mentally compromised children.
• Children with a history of prolonged bleeding, platelet disorders, hypersensitivity,
• History of significant behavior management problems.
• Patients having active sites of pathosis in the area of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single buccal infiltration using 4%articaine; Dryness the site of injection then application of topical anesthetic gel(2% benzocaine). Injecting by a small amount of solution in the superficial mucosa. After a few seconds, the needle was slowly advanced in the mucobuccal fold toward the apex of the molar and 1.8 ml of 4% articaine using short 30-gauge needle was slowly given. Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed by inquiring about the area of numbness from the participant, no pain during pricking the palatal mucosa. The cases in which palatal anesthesia will not be reported by the patient will be given supplemental palatal infiltration with 0.2 to 0.3 mL articaine. After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.	Other: Single buccal infiltration; painless technique for palatal anesthesia,single injection,single puncture given
ACTIVE_COMPARATOR: Buccal and intrapapillary infiltration using 4%articaine; Dryness the site of injection then application of topical anesthetic gel(2% benzocaine) Injecting a small amount of solution in the superficial mucosa,then needle will slowly advanced in the mucobuccal fold toward the apex of the molar and 1.5 ml of 4% articaine was slowly given. The remaining 0.3ml solution will be given equally into the distal, mesial intrapapillary and palatal sites respectively until blanching of the palate is observed extending more than halfway along the palatal gingival margin. Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed. After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.	Other: Single buccal infiltration; painless technique for palatal anesthesia,single injection,single puncture given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior pain assessment during anesthesia and extraction	FLACC Behavioral Pain Scale will be used for assessment during anaesthesia and extraction. This scale consists of 5 categories face, leg, activity, cry, consolabilty. Each category is scored on the 0-2 scale, which results in a total score of 0-10.	Intraoperative
Subjective self report pain assessment after anesthesia and extraction	Second subjective self report assesment will be done using Wong-baker scale after the anaesthsia and extraction.It consist of a set of cartoon faces with varying facial expression ranging from smile/laughter to tears.• Each face has a numerical value ranging from 0-5.	intraoperative
physiological record of pain after anesthesia and extraction	phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 14422017496954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol, informed consent, clinical study report
• IPD Sharing Time Frame: After completion of the study
• IPD Sharing Access Criteria: ClinicalTrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No