- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443726
Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Catalunya
-
L´hospitalet de Llobregat, Catalunya, Spain, 08903
- University of Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infiltrative technique
Patients in this arm will have buccal and lingual infiltrative anesthesia with 4% articaine 1:100.000
epinephrine for third molar extraction.
|
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.
Other Names:
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
Third molar extraction under local anesthesia.
|
Active Comparator: Nerve block technique
Patients in this arm will have inferior alveolar nerve and buccal nerve block with 4% articaine 1:100.000
epinephrine for third molar extraction.
|
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
Third molar extraction under local anesthesia.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for supplemental anesthesia [Efficacy]
Time Frame: 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)
|
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
Time Frame: 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]
|
After local anesthetic injection (minute 0)
|
Morbidity
Time Frame: After local anesthetic injection (minute 0)
|
Using a questionnaire.
Electrical shock sensation affecting lower lip and/or tongue (yes/no).
|
After local anesthetic injection (minute 0)
|
Latency
Time Frame: 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).
|
After anesthetic injection (approximately 0 to 360 seconds)
|
Pulpal anesthesia
Time Frame: 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. |
Minute 1 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 1.5 (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. |
Minute 1.5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 2 (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. |
Minute 2 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 2.5 (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. |
Minute 2.5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 3 (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. |
Minute 3 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 3.5 (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. |
Minute 3.5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 4 (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. |
Minute 4 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 4.5 (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. |
Minute 4.5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 5 (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. |
Minute 5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 5.5 (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. |
Minute 5.5 (after Vincent's sign is achieved)
|
Pulpal anesthesia
Time Frame: Minute 6 (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. |
Minute 6 (after Vincent's sign is achieved)
|
Surgery pain
Time Frame: 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]
|
At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
|
Post operative pain
Time Frame: 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]
|
2 hours
|
Post operative pain
Time Frame: 6 hours
|
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
Time Frame: 12 hours
|
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
Time Frame: 24 hours
|
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
Time Frame: Day 1
|
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
Time Frame: Day 2
|
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
Time Frame: Day 3
|
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
Time Frame: Day 4
|
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
Time Frame: Day 5
|
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
Time Frame: Day 6
|
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
Time Frame: Day 7
|
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]
Time Frame: 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)
|
Day 7
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rui Figueiredo, DDS, MS, PhD, University of Barcelona
- Study Chair: Eduard Valmaseda-Castellon, DDS, MS. PhD, University of Barcelona
- Principal Investigator: Stavros J Sofos, DDS, MS., University of Barcelona, Nova Southeastern University.
- Principal Investigator: Leonardo Berini-Aytes, MD, DDS, PhD, University of Barcelona
- Principal Investigator: Octavi Camps-Font, DDS, MS, University of Barcelona
Publications and helpful links
General Publications
- Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
- Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17.
- Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.
- Berini Aytés L, Gay Escoda C, Uribarri A. Técnica de anestesia por bloqueo en la mandíbula. En: Berini Aytés L, Gay Escoda C. (eds.). Anestesia Odontológica, 3o ed. Madrid: Avances médico- dentales; 2005. p. 253-79.
- Meechan JG. The use of the mandibular infiltration anesthetic technique in adults. J Am Dent Assoc. 2011 Sep;142 Suppl 3:19S-24S. doi: 10.14219/jada.archive.2011.0343.
- Meechan JG. Infiltration anesthesia in the mandible. Dent Clin North Am. 2010 Oct;54(4):621-9. doi: 10.1016/j.cden.2010.06.003.
- Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks. J Am Dent Assoc. 2000 Jul;131(7):901-7. doi: 10.14219/jada.archive.2000.0308. Erratum In: J Am Dent Assoc 2000 Oct;131(10):1418.
- Renton T, Adey-Viscuso D, Meechan JG, Yilmaz Z. Trigeminal nerve injuries in relation to the local anaesthesia in mandibular injections. Br Dent J. 2010 Nov;209(9):E15. doi: 10.1038/sj.bdj.2010.978.
- Hillerup S, Jensen R. Nerve injury caused by mandibular block analgesia. Int J Oral Maxillofac Surg. 2006 May;35(5):437-43. doi: 10.1016/j.ijom.2005.10.004. Epub 2005 Dec 15.
- Delgado-Molina E, Tamarit-Borras M, Berini-Aytes L, Gay-Escoda C. Comparative study of two needle models in terms of deflection during inferior alveolar nerve block. Med Oral Patol Oral Cir Bucal. 2009 Sep 1;14(9):e440-4.
- Hillerup S, Jensen RH, Ersboll BK. Trigeminal nerve injury associated with injection of local anesthetics: needle lesion or neurotoxicity? J Am Dent Assoc. 2011 May;142(5):531-9. doi: 10.14219/jada.archive.2011.0223.
- Moore PA, Haas DA. Paresthesias in dentistry. Dent Clin North Am. 2010 Oct;54(4):715-30. doi: 10.1016/j.cden.2010.06.016.
- Garisto GA, Gaffen AS, Lawrence HP, Tenenbaum HC, Haas DA. Occurrence of paresthesia after dental local anesthetic administration in the United States. J Am Dent Assoc. 2010 Jul;141(7):836-44. doi: 10.14219/jada.archive.2010.0281. Erratum In: J Am Dent Assoc. 2010 Aug;141(8):944.
- Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.
- Malamed SF, Gagnon S, Leblanc D. Articaine hydrochloride: a study of the safety of a new amide local anesthetic. J Am Dent Assoc. 2001 Feb;132(2):177-85. doi: 10.14219/jada.archive.2001.0152.
- Gay Escoda C, Berini Aytés. Técnicas anestésicas en Cirugía Bucal. En: Tratado de Cirugía Bucal. Madrid: Ergon; 2004. p. 155-98
- Torrente-Castells E, Gargallo-Albiol J, Rodriguez-Baeza A, Berini-Aytes L, Gay-Escoda C. Necrosis of the skin of the chin: a possible complication of inferior alveolar nerve block injection. J Am Dent Assoc. 2008 Dec;139(12):1625-30. doi: 10.14219/jada.archive.2008.0104.
- Brandt RG, Anderson PF, McDonald NJ, Sohn W, Peters MC. The pulpal anesthetic efficacy of articaine versus lidocaine in dentistry: a meta-analysis. J Am Dent Assoc. 2011 May;142(5):493-504. doi: 10.14219/jada.archive.2011.0219.
- Meechan JG, Jaber AA, Corbett IP, Whitworth JM. Buccal versus lingual articaine infiltration for mandibular tooth anaesthesia: a randomized controlled trial. Int Endod J. 2011 Jul;44(7):676-81. doi: 10.1111/j.1365-2591.2011.01878.x. Epub 2011 Mar 30.
- El-Kholey KE. Infiltration anesthesia for extraction of the mandibular molars. J Oral Maxillofac Surg. 2013 Oct;71(10):1658.e1-5. doi: 10.1016/j.joms.2013.06.203.
- Montserrat-Bosch M, Figueiredo R, Nogueira-Magalhaes P, Arnabat-Dominguez J, Valmaseda-Castellon E, Gay-Escoda C. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2014 Jul 1;19(4):e391-7. doi: 10.4317/medoral.19554.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Carticaine
Other Study ID Numbers
- UBarcelonaOralSurgery1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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