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Clinical Trials/NCT04458142
NCT04458142
Unknown
Not Applicable

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

Cairo University0 sites25 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Cairo University
Enrollment
25
Primary Endpoint
Behavior pain assessment during anesthesia and extraction
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
March 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadil Ahmed Mohamed Ahmed ELSafty

principle investigator

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Behavior pain assessment during anesthesia and extraction

Time Frame: Intraoperative

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.

Subjective self report pain assessment after anesthesia and extraction

Time Frame: intraoperative

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.

physiological record of pain after anesthesia and extraction

Time Frame: intraoperative

phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.

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