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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443726
• Other study ID #: UBarcelonaOralSurgery1
• Status: Completed
• Phase: N/A
• Start date: June 10, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: March 2020
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 20, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Anesthesia
• Tooth Extraction

Intervention

Procedure:
• Nerve 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.
• Infiltrative 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.

Drug:
• 4% articaine 1:100.000 epinephrine
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)

Procedure:
• Third molar extraction
Third molar extraction under local anesthesia.

Locations

Country	Name	City	State
Spain	University of Barcelona	L´hospitalet de Llobregat	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & 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.

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. — View Citation

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. — View Citation

Delgado-Molina E, Tamarit-Borras M, Berini-Aytés 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. — View Citation

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. — View Citation

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

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. Erratum in: J Am Dent Assoc. 2010 Aug;141(8):944. — View Citation

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

Hillerup S, Jensen R. Nerve injury caused by mandibular block analgesia. Int J Oral Maxillofac Surg. 2006 May;35(5):437-43. Epub 2005 Dec 15. — View Citation

Hillerup S, Jensen RH, Ersbøll BK. Trigeminal nerve injury associated with injection of local anesthetics: needle lesion or neurotoxicity? J Am Dent Assoc. 2011 May;142(5):531-9. — View Citation

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. Epub 2006 Feb 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Meechan JG. The use of the mandibular infiltration anesthetic technique in adults. J Am Dent Assoc. 2011 Sep;142 Suppl 3:19S-24S. Review. — View Citation

Montserrat-Bosch M, Figueiredo R, Nogueira-Magalhães P, Arnabat-Dominguez J, Valmaseda-Castellón 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. — View Citation

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. Review. — View Citation

Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks. J Am Dent Assoc. 2000 Jul;131(7):901-7. Erratum in: J Am Dent Assoc 2000 Oct;131(10):1418. — View Citation

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. — View Citation

Torrente-Castells E, Gargallo-Albiol J, Rodríguez-Baeza A, Berini-Aytés 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Morbidity	Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no).	After local anesthetic injection (minute 0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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