Clinical trial NCT04458142: Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Behavior pain assessment during anesthesia and extraction
timeFrame: Intraoperative
measure: Subjective self report pain assessment after anesthesia and extraction
timeFrame: intraoperative
measure: physiological record of pain after anesthesia and extraction
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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