Dental Anesthesia, Tooth Extraction
Conditions
Keywords
Lower third molar extraction, Infiltration anesthesia, Articaine
Brief 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).
Interventions
PROCEDURENerve 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.
PROCEDUREInfiltrative 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.
DRUG4% articaine 1:100.000 epinephrine
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
PROCEDUREThird molar extraction
Third molar extraction under local anesthesia.
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
* The participant is not told which technique will be used on him/her. * Surgeon does not know the anesthetic technique used to numb the third molar. * When the statistician and primary investigator receive the collected data to be analyzed, the techniques are labeled 1 and 2.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for supplemental anesthesia [Efficacy] | At the end of surgery (≤60 minutes after pulpal anesthesia is achieved) | Using a questionnaire filled by the surgeon at the end of surgery. Need for supplemental anesthesia (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | After local anesthetic injection (minute 0) | Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no). |
| Latency | After anesthetic injection (approximately 0 to 360 seconds) | Time elapsed from anesthetic injection to numbness of tongue and lower lip (Vicent's sign) reported by the patient (seconds). |
| Pulpal anesthesia | Minute 1 (after Vincent's sign is achieved) | Using an electronic pulp tester placed on the mesiobuccal cusp tip of ipsilateral lower second molar. No response at 80 units. |
| Local anesthetic injection pain | After local anesthetic injection (minute 0) | Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\] |
| Post operative pain | 2 hours | Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\] |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Day 7 | 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) |
| Surgery pain | At the end of surgery (≤60 minutes after pulpal anesthesia is achieved) | Measured by a 100 mm Visual Analog Scale (VAS) Range: 0 mm \[No pain. Best outcome\] to 100 mm \[Worst pain. Worst outcome\] |
Countries
Spain
Outcome results
None listed