NCT03443726

Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a Randomized Controlled Trial (RCT) which objective is to compare the effectiveness, efficacy and complication associated to an infiltrative anesthetic technique for the removal of lower third molars comparing it to the standard inferior alveolar nerve block using 4% articaine 1:100.000 epinephrine.

Detailed description

The objective is to compare the anesthetic efficacy of an infiltrative anesthetic technique placed buccally between the first and second mandibular molars plus infiltration of the third molar's lingual mucosa with the direct inferior alveolar nerve block plus buccal nerve block for the extraction of lower wisdom teeth. All using 4% articaine 1:100.000 epinephrine. The first technique is to be referred as Alternative Technique (A.T.) and the second Standard Technique (S.T.) The study is being conducted at the Hospital Odontològic Universitat de Barcelona (Campus de Bellvitge) and is being carried out by members of the Oral Surgery and Implantology Master's program of the University of Barcelona. The sample (110 patients) consists of patients in need of lower third molar extraction. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. All patients derive from the Institut Català de la Salut-Consorci Sanitari. The materials used are 1.8cc carpules of 4% articaine and 1:100.000 epinephrine, dental anesthetic syringe, dental anesthetic needles of 35 mm 27G and 25 mm 27G as well as all the documents necessary for data collection. The determinations to be done are the pulpal anesthetic efficacy (in seconds, using a pulpometer), chin and tongue numbness (patient reported, measured in seconds), need for supplemental anesthesia, comfort (pain experienced during the punctions and during and after surgery), morbility (cramp sensation in the tongue or lip when performing the anesthetic technique, local and/or systemic complications).

Conditions

• Tooth Extraction
• Dental Anesthesia

Interventions

Type	Name	Description
PROCEDURE	Nerve block technique	Inferior alveolar nerve block with 1.8 cc of 4% articaine 1:100.000 epinephrine and 1.8 cc of the same anesthetic for the buccal nerve for third molar extraction.
PROCEDURE	Infiltrative technique	Infiltrative anesthesia buccally between first and second mandibular molar with 3.6 cc of 4% articaine 1:100.000 epinephrine and 0.6 cc lingually to the third molar using the same anesthetic solution.
DRUG	4% articaine 1:100.000 epinephrine	Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
PROCEDURE	Third molar extraction	Third molar extraction under local anesthesia.

Timeline

• Start date: 2017-06-10
• Primary completion: 2018-11-10
• Completion: 2018-12-20
• First posted: 2018-02-23
• Last updated: 2020-03-31

Locations

1 site across 1 country: Spain