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

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ClinicalTrials.gov Identifier: NCT03443726
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rui Figueiredo, University of Barcelona

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.

Condition or disease Intervention/treatment Phase
Tooth Extraction Dental Anesthesia Procedure: Nerve block technique Procedure: Infiltrative technique Drug: 4% articaine 1:100.000 epinephrine Procedure: Third molar extraction Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
Actual Study Start Date : June 10, 2017
Estimated Primary Completion Date : June 10, 2018
Estimated Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Articaine

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.
Procedure: 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.
Other Name: Experimental intervention

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.

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.
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.
Other Name: Standard intervention

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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]

  2. Morbidity [ Time Frame: After local anesthetic injection (minute 0) ]
    Using a questionnaire. Electrical shock sensation affecting lower lip and/or tongue (yes/no).

  3. 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).

  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.


  10. 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.


  11. 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.


  12. 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.


  13. 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.


  14. 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.


  15. 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]

  16. 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]

  17. 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]

  18. 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]

  19. 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]

  20. 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]

  21. 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]

  22. 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]

  23. 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]

  24. 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]

  25. 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]

  26. 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]

  27. 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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443726


Contacts
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Contact: Stavros J Sofos, DDS, MS. +19548125541 stavros.sofos@gmail.com
Contact: Octavi J Camps-Font, DDS, MS. +34665980569 occafo@gmail.com

Locations
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Spain
University of Barcelona Recruiting
L´hospitalet de Llobregat, Catalunya, Spain, 08903
Contact: Octavi Camps-Font, DDS, MS    +34667378126    occafo@gmail.com   
Contact: Rui Figueiredo, DDS, MS, PhD    +34665980569    ruipfigueiredo@hotmail.com   
Principal Investigator: Stavros Sofos, DDS, MS.         
Principal Investigator: Rui Figueiredo, DDS, MS, PhD         
Principal Investigator: Eduard Valmaseda-Castellon, DDS, MS, PhD         
Sub-Investigator: Octavi Camps-Font, DDS, MS         
Sub-Investigator: Gemma Sammarti-Garcia, DDS, MS         
Sub-Investigator: Eduard Soriano-Pons, DDS         
Principal Investigator: Leonardo Berini-Aytes, MD, DDS, PhD         
Sponsors and Collaborators
University of Barcelona
Investigators
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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:
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.
Gay Escoda C, Berini Aytés. Técnicas anestésicas en Cirugía Bucal. En: Tratado de Cirugía Bucal. Madrid: Ergon; 2004. p. 155-98

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Responsible Party: Rui Figueiredo, Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT03443726     History of Changes
Other Study ID Numbers: UBarcelonaOralSurgery1
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rui Figueiredo, University of Barcelona:
Lower third molar extraction
Infiltration anesthesia
Articaine

Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Anesthetics
Carticaine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anesthetics, Local
Sensory System Agents