Tooth ExtractionNCT03443726

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

A study testing Nerve block technique, Infiltrative technique and 4% articaine 1:100.000 epinephrine in people with Tooth Extraction and Dental Anesthesia, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Extraction, Dental Anesthesia
What is being tested?: Nerve block technique, Infiltrative technique and 4% articaine 1:100.000 epinephrine
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSpain
Study dates: 10 Jun 2017to 20 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

A score equal or superior to 13 points in the Corah´s anxiety test.
Third molars in ectopic position.
Caries on the third molar.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Barcelona
L'Hospitalet de Llobregat, Catalonia, 08903

Other trials in Spain

About this study

Read the 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).

Conditions: Tooth Extraction, Dental Anesthesia
Being tested: Nerve block technique, Infiltrative technique, 4% articaine 1:100.000 epinephrine, Third molar extraction
Keywords: Lower third molar extraction, Infiltration anesthesia, Articaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nerve block techniqueProcedure or surgery
Also called Standard intervention
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 techniqueProcedure or surgery
Also called Experimental intervention
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.
4% articaine 1:100.000 epinephrineDrug
Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
Third molar extractionProcedure or surgery
Third molar extraction under local anesthesia.

Study groups in NCT03443726
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Nerve block technique; Drug: 4% articaine 1:100.000 epinephrine; Procedure: Third molar extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

Need for supplemental anesthesia [Efficacy]
Using a questionnaire filled by the surgeon at the end of surgery. Need for supplemental anesthesia (yes/no)
Measured: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)

Secondary outcomes (27)

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]
Measured: After local anesthetic injection (minute 0)
Morbidity
Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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)
Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201720 Dec 2018

First posted23 Feb 2018
Study start10 Jun 2017
Primary completion10 Nov 2018
Study completion20 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Tooth ExtractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03443726
Sponsor's protocol ID: UBarcelonaOralSurgery1
Status last verified: Mar 2020
First submitted: 20 Dec 2017
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 21881058
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.
PubMed 16554198
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.
PubMed 19228214
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.
PubMed 18436027
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.
PubMed 20831926
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.
PubMed 10916328
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.
PubMed 21072069
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.
PubMed 16343853
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.
PubMed 19718006
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.
PubMed 21531935
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.
PubMed 20831934
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.
PubMed 20592403
Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.
PubMed 19840499
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.
PubMed 11217590

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 4
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Recruiting
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All Tooth Extraction trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
ClinicalTrials.gov ID: NCT03443726
Acronym / sponsor ID: UBarcelonaOralSurgery1
Conditions: Tooth Extraction, Dental Anesthesia
Keywords: Lower third molar extraction, Infiltration anesthesia, Articaine
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of BarcelonaUniversity, hospital or other
Study start: 10 Jun 2017 (actual)
Primary completion: 10 Nov 2018 (actual)
Study completion: 20 Dec 2018 (actual)
First posted: 23 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Infiltrative technique	Experimental	Procedure: Infiltrative technique, Drug: 4% articaine 1:100.000 epinephrine, Procedure: Third molar extractionPatients in this arm will have buccal and lingual infiltrative anesthesia with 4% articaine 1:100.000 epinephrine for third molar extraction.
Nerve block technique	Active comparator	Procedure: Nerve block technique, Drug: 4% articaine 1:100.000 epinephrine, Procedure: Third molar extractionPatients in this arm will have inferior alveolar nerve and buccal nerve block with 4% articaine 1:100.000 epinephrine for third molar extraction.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nerve block techniqueAlso: Standard interventionInferior 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.	Procedure or surgery	Nerve block technique
Infiltrative techniqueAlso: Experimental interventionInfiltrative 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.	Procedure or surgery	Infiltrative technique
4% articaine 1:100.000 epinephrineArticaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)	Drug	Infiltrative technique, Nerve block technique
Third molar extractionThird molar extraction under local anesthesia.	Procedure or surgery	Infiltrative technique, Nerve block technique

Primary outcome

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)

27 secondary outcomes

Local anesthetic injection pain
Time frame: After local anesthetic injection (minute 0)
Morbidity
Time frame: After local anesthetic injection (minute 0)
Latency
Time frame: After anesthetic injection (approximately 0 to 360 seconds)
Pulpal anesthesia
Time frame: Minute 1 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 1.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 2 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 2.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 3 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 3.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 4 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 4.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 5.5 (after Vincent's sign is achieved)
Pulpal anesthesia
Time frame: Minute 6 (after Vincent's sign is achieved)
Surgery pain
Time frame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
Post operative pain
Time frame: 2 hours
Post operative pain
Time frame: 6 hours
Post operative pain
Time frame: 12 hours
Post operative pain
Time frame: 24 hours
Post operative pain
Time frame: Day 1
Post operative pain
Time frame: Day 2
Post operative pain
Time frame: Day 3
Post operative pain
Time frame: Day 4
Post operative pain
Time frame: Day 5
Post operative pain
Time frame: Day 6
Post operative pain
Time frame: Day 7
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
BackgroundBerini 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: PubMed 21881058Meechan 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.
Background: PubMed 16554198Kanaa 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.
Background: PubMed 19228214Kanaa 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.
Background: PubMed 18436027Corbett 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.
Background: PubMed 20831926Meechan JG. Infiltration anesthesia in the mandible. Dent Clin North Am. 2010 Oct;54(4):621-9. doi: 10.1016/j.cden.2010.06.003.
Background: PubMed 10916328Pogrel 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.
Background: PubMed 21072069Renton 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.
Background: PubMed 16343853Hillerup 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.
Background: PubMed 19718006Delgado-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.
Background: PubMed 21531935Hillerup 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.
Background: PubMed 20831934Moore PA, Haas DA. Paresthesias in dentistry. Dent Clin North Am. 2010 Oct;54(4):715-30. doi: 10.1016/j.cden.2010.06.016.
Individual participant dataSharing planned: Undecided

Related trials for Tooth Extraction

RecruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rui Figueiredo, DDS, MS, PhD study director

University of Barcelona

Eduard Valmaseda-Castellon, DDS, MS. PhD study chair

University of Barcelona

Stavros J Sofos, DDS, MS. principal investigator

University of Barcelona, Nova Southeastern University.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for supplemental anesthesia [Efficacy] (time frame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443726, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.