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

NCT03443726 | Completed DMC

• 1 other identifier: UBarcelonaOralSurgery1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction; Dental Anesthesia

Keywords

Lower third molar extraction; Infiltration anesthesia; Articaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Local anesthetic injection pain

  After local anesthetic injection (minute 0)

• Morbidity

  After local anesthetic injection (minute 0)

• Latency

  After anesthetic injection (approximately 0 to 360 seconds)

• Pulpal anesthesia

  Minute 1 (after Vincent's sign is achieved)

• Pulpal anesthesia

  Minute 1.5 (after Vincent's sign is achieved)

Study Arms (2)

Infiltrative technique

EXPERIMENTAL

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

Nerve block technique

ACTIVE COMPARATOR

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

Interventions

Nerve block technique PROCEDURE

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

Nerve block technique

Infiltrative technique PROCEDURE

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

Infiltrative technique

4% articaine 1:100.000 epinephrine DRUG

Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)

Infiltrative technique; Nerve block technique

Third molar extraction PROCEDURE

Third molar extraction under local anesthesia.

Infiltrative technique; Nerve block technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08903, Spain

Location

Related Publications (21)

• 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.

  BACKGROUND

• 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.

  PMID: 21881058 BACKGROUND

• 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.

  PMID: 16554198 BACKGROUND

• 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.

  PMID: 19228214 BACKGROUND

• 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.

  PMID: 18436027 BACKGROUND

• 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.

  PMID: 20831926 BACKGROUND

• 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.

  PMID: 10916328 BACKGROUND

• 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.

  PMID: 21072069 BACKGROUND

• 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.

  PMID: 16343853 BACKGROUND

• 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.

  PMID: 19718006 BACKGROUND

• 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.

  PMID: 21531935 BACKGROUND

• 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.

  PMID: 20831934 BACKGROUND

• 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.

  PMID: 20592403 BACKGROUND

• Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.

  PMID: 19840499 BACKGROUND

• 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.

  PMID: 11217590 BACKGROUND

• Gay Escoda C, Berini Aytés. Técnicas anestésicas en Cirugía Bucal. En: Tratado de Cirugía Bucal. Madrid: Ergon; 2004. p. 155-98

  BACKGROUND

• 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.

  PMID: 19047668 BACKGROUND

• 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.

  PMID: 21531931 BACKGROUND

• 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.

  PMID: 21447137 BACKGROUND

• 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.

  PMID: 24040947 BACKGROUND

• 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.

  PMID: 24608204 BACKGROUND

MeSH Terms

Interventions

Carticaine; Epinephrine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Rui Figueiredo, DDS, MS, PhD

  University of Barcelona

  STUDY DIRECTOR

• Eduard Valmaseda-Castellon, DDS, MS. PhD

  University of Barcelona

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * 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.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 23, 2018
• Study Start: June 10, 2017
• Primary Completion: November 10, 2018
• Study Completion: December 20, 2018
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

ES (1)