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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Tooth Extraction, Dental Anesthesia

Intervention / Treatment
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* Procedure: Nerve block technique
* Procedure: Infiltrative technique
* Drug: 4% articaine 1:100.000 epinephrine
* Procedure: Third molar extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lower third molars in any position (in accordance to Pell and Gregory and Winter classification) in need of extraction. Healthy patients and patients with mild systemic disease without substantive functional limitations (ASA I-II). Absence of acute infection in the third molar area. Adequate intellectual capacity for understanding the nature and purpose of the study and fill the informed consent and questionaries appropriately. Exclusion Criteria: History of recent trauma in the maxillofacial area. Articaine or lidocaine allergy. Presence of a systemic pathology that contraindicates the use of local anesthetics with vasopressors. Acute infection in the third molar area (in the las 30 days). Surgeries taking more than 60 minutes (automatic dropout). Unwillingness to participate or continue participating in the study. A score equal or superior to 13 points in the Corah´s anxiety test. Third molars in ectopic position. Caries on the third molar.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: 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 block. Test group: infiltration anesthesia buccaly between first and second mandibular molar with 3.6 cc of 4% articaine 1:100.000 epinephrine and 0.6 cc ligually to the third molar using the same anesthetic.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infiltrative technique<br>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<br>* 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.<br>* Other names: Experimental intervention;Drug: 4% articaine 1:100.000 epinephrine<br>* Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)<br>Procedure: Third molar extraction<br>* Third molar extraction under local anesthesia.<br>|
| Active Comparator: Nerve block technique<br>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<br>* 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.<br>* Other names: Standard intervention;Drug: 4% articaine 1:100.000 epinephrine<br>* Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)<br>Procedure: Third molar extraction<br>* Third molar extraction under local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for supplemental anesthesia [Efficacy] | Using a questionnaire filled by the surgeon at the end of surgery. Need for supplemental anesthesia (yes/no) | At the end of surgery (≤60 minutes after pulpal anesthesia is achieved) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | After local anesthetic injection (minute 0) | 
| Morbidity | Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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] | 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) | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower third molar extraction, Infiltration anesthesia, Articaine