Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04458142
• Other study ID #: 14422017496954
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Other:
• Single buccal infiltration
painless technique for palatal anesthesia,single injection,single puncture given

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	physiological record of pain after anesthesia and extraction	phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.	intraoperative