Clinical trial NCT03443726: Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
Official title: Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Dental Anesthesia
Keywords: Lower third molar extraction
Infiltration anesthesia
Articaine
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: Need for supplemental anesthesia [Efficacy]
timeFrame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
Secondary outcomes:
measure: Local anesthetic injection pain
timeFrame: After local anesthetic injection (minute 0)
measure: Morbidity
timeFrame: After local anesthetic injection (minute 0)
measure: Latency
timeFrame: After anesthetic injection (approximately 0 to 360 seconds)
measure: Pulpal anesthesia
timeFrame: Minute 1 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 1.5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 2 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 2.5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 3 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 3.5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 4 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 4.5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 5.5 (after Vincent's sign is achieved)
measure: Pulpal anesthesia
timeFrame: Minute 6 (after Vincent's sign is achieved)
measure: Surgery pain
timeFrame: At the end of surgery (≤60 minutes after pulpal anesthesia is achieved)
measure: Post operative pain
timeFrame: 2 hours
measure: Post operative pain
timeFrame: 6 hours
measure: Post operative pain
timeFrame: 12 hours
measure: Post operative pain
timeFrame: 24 hours
measure: Post operative pain
timeFrame: Day 1
measure: Post operative pain
timeFrame: Day 2
measure: Post operative pain
timeFrame: Day 3
measure: Post operative pain
timeFrame: Day 4
measure: Post operative pain
timeFrame: Day 5
measure: Post operative pain
timeFrame: Day 6
measure: Post operative pain
timeFrame: Day 7
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Day 7
Other outcomes:
Locations:
city: L´hospitalet de Llobregat
country: Spain
facility: University of Barcelona
state: Catalunya
Study officials:
affiliation: University of Barcelona
name: Rui Figueiredo, DDS, MS, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Eduard Valmaseda-Castellon, DDS, MS. PhD
role: STUDY_CHAIR
affiliation: University of Barcelona, Nova Southeastern University.
name: Stavros J Sofos, DDS, MS.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Leonardo Berini-Aytes, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Octavi Camps-Font, DDS, MS
role: PRINCIPAL_INVESTIGATOR
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