Skip to main content
OpenTrials
Completed

NCT Number: NCT03443726

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tooth Extraction Dental Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08903, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Standard intervention

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.

Other names: Experimental intervention

4% articaine 1:100.000 epinephrine

Drug

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

Third molar extraction

Procedure

Third molar extraction under local anesthesia.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.