An interventional study of Nerve block technique and Infiltrative technique in Tooth Extraction and Dental Anesthesia, sponsored by University of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by University of Barcelona · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Patients in this arm will have buccal and lingual infiltrative anesthesia with 4% articaine 1:100.000 epinephrine for third molar extraction.
Procedure: Infiltrative technique · Drug: 4% articaine 1:100.000 epinephrine · Procedure: Third molar extraction
Patients in this arm will have inferior alveolar nerve and buccal nerve block with 4% articaine 1:100.000 epinephrine for third molar extraction.
Procedure: Nerve block technique · Drug: 4% articaine 1:100.000 epinephrine · Procedure: Third molar extraction
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.
Also known as: Standard intervention
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.
Also known as: Experimental intervention
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
Third molar extraction under local anesthesia.
Need for supplemental anesthesia [Efficacy]
Using a questionnaire filled by the surgeon at the end of surgery. Need for supplemental anesthesia (yes/no)
Time frame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
Local anesthetic injection pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: After local anesthetic injection (minute 0)
Morbidity
Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no).
Time frame: After local anesthetic injection (minute 0)
Latency
Time elapsed from anesthetic injection to numbness of tongue and lower lip (Vicent's sign) reported by the patient (seconds).
Time frame: After anesthetic injection (approximately 0 to 360 seconds)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 1 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 1.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 2 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 2.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 3 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 3.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 4 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 4.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 5.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units.
Time frame: Minute 6 (after Vincent's sign is achieved)
Surgery pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: 2 hours
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: 6 hours
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: 12 hours
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: 24 hours
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 1
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 2
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 3
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 4
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 5
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 6
Post operative pain
Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\]
Time frame: Day 7
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Using a questionnaire filled by the surgeon at the end of study visit. Pruritus, nausea, vomiting, bleeding, anesthesia of the mouth, difficulty breathing, drowsiness, headache, sweating, palpitations, skin rash, difficult deglutition and dysarthria during the follow-up period (yes/no)
Time frame: Day 7
Plan to share: Undecided
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University of Barcelona