Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration

NCT ID: NCT04458142

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-03-01

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.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Single buccal infiltration

Intervention Type: OTHER

painless technique for palatal anesthesia,single injection,single puncture given

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.

Group Type: ACTIVE_COMPARATOR

Single buccal infiltration

Intervention Type: OTHER

painless technique for palatal anesthesia,single injection,single puncture given

Interventions

Single buccal infiltration

painless technique for palatal anesthesia,single injection,single puncture given

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadil Ahmed Mohamed Ahmed ELSafty

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

14422017496954

Identifier Type: -

Identifier Source: org_study_id