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MolarNCT06009302

Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars

A study testing US guided block of mandibular nerve and Intraoral block of lower alveolar nerve in people with Molar and Impacted Teeth, run by Varazdin General Hospital at 1 site in Croatia.

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 is a study about the dynamics and effects of different types of blocks (intraoral conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve) for extraction of lower third molars. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Molar, Impacted Teeth
What is being tested?
US guided block of mandibular nerve and Intraoral block of lower alveolar nerve
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCroatia
Study dates
1 Sep 2023to 31 Dec 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18-64 years
  • horizontally placed lower third molars
  • ASA I or II group

Who cannot join

  • allergy to local anesthetics
  • local infection at the site of needle puncture
  • parotitis
  • serious liver disease
  • use of antiarrhythmics group III (eg amiodarone), anticoagulant or antithrombotic drugs
  • lactation
  • people who took an analgesic as a preventive measure before coming to the procedure

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Varazdin General Hospital

    Varaždin, 42000

Other trials in Croatia

About this study

This is a study about the dynamics and effects of different types of blocks (intraoral conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve) for extraction of lower third molars.

Read the detailed description

Standard method of anesthesia for extraction of horizontally positioned lower thirdmolars is intraoral conduction anesthesia of the inferior alveolar nerve. However, the analgesiceffect of block is short and it is necessary to use analgesics. In this prospective clinical study,analgesic effect of ultrasound (US) -guided extraoral block of mandibular nerve will beinvestigated, in order to prolong pain-free time and reduce the use of analgesics associated withrisks (bleeding, hepatotoxicity).

Characteristics of alveolar nerve block and US block of the mandibular nerve will becompared, such as: pain during application of anesthesia, amount of anesthetic, duration ofanesthesia, need to use analgesics, time to and level of pain when using analgesics, andcomplications

Being tested
US guided block of mandibular nerve, Intraoral block of lower alveolar nerve
Keywords
dental anesthesia, inferior alveolar nerve, regional anesthesia, ultrasound, mandibular nerve
Medical subject headings
Tooth, Impacted

What participants receive

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

  • US guided block of mandibular nerveProcedure or surgery

    Extraoral ultrasound-guided block of the mandibular nerve will be performed in the examined group using an ultrasound device, using ropivacaine (0.75%, 2.5 mL).

  • Intraoral block of lower alveolar nerveProcedure or surgery

    Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline

Study groups in NCT06009302
Study groupRoleWhat they receive
US block of mandibular nerveExperimentalExtraoral ultrasound-guided block of the mandibular nerve will be performed iusing an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic ropivacaine (0.75%, 2.5 mL) will be applied.
Receives: Procedure: US guided block of mandibular nerve
intraoral block of lower alveolar nerveActive comparatorDuring the intraoral block of the inferior alveolar nerve, the patient will lie with his mouth wide open, and the inferior alveolar, lingual and buccal nerves will be anesthetized using two injections. The anesthetic used will be 40 mg/mL articaine chloride+0.01 mg/mL epinephrine: the planned amount of anesthetic is 2×1.7 mL, and if anesthesia is not achieved, an additional volume of anesthetic will be added as needed, until anesthesia
Receives: Procedure: Intraoral block of lower alveolar nerve

What is being measured

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

  1. Time without pain

    Measured: first 24 postoperative hours

Secondary outcomes (3)

  1. Time of numbness

    Measured: first 24 postoperative hours

  2. Pain level when anesthesia is applied

    0-10 on VAS

    Measured: first 24 postoperative hours

  3. Pain level when painkiller is needed

    0-10 on VAS

    Measured: first 24 postoperative hours

Timeline

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

  1. First posted24 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06009302
Sponsor's protocol ID
12071987
Status last verified
Aug 2023
First submitted
18 Aug 2023
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prospects. 2010 Fall;4(4):105-9. doi: 10.5681/joddd.2010.027. Epub 2010 Dec 21.

    PubMed 23346335

  • Fisher SE, Frame JW, Rout PG, McEntegart DJ. Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J. 1988 Jun 11;164(11):351-4. doi: 10.1038/sj.bdj.4806453. No abstract available.

    PubMed 3165011

  • Teoh L, Moses G, McCullough MJ. A review of drugs that contribute to bleeding risk in general dental practice. Aust Dent J. 2020 Jun;65(2):118-130. doi: 10.1111/adj.12751. Epub 2020 Mar 13.

    PubMed 32064612

  • Plantevin F, Pascal J, Morel J, Roussier M, Charier D, Prades JM, Auboyer C, Molliex S. Effect of mandibular nerve block on postoperative analgesia in patients undergoing oropharyngeal carcinoma surgery under general anaesthesia. Br J Anaesth. 2007 Nov;99(5):708-12. doi: 10.1093/bja/aem242. Epub 2007 Sep 19.

    PubMed 17884802

  • Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.

    PubMed 30532323

  • Stojanovic S, Buric N, Tijanic M, Todorovic K, Buric K, Buric N, Jovanovic M, Bajagic V. The Assessment of Prolonged Inferior Alveolar Nerve Blockade for Postoperative Analgesia in Mandibular Third Molar Surgery by a Perineural Addition of Dexamethasone to 0.5% Ropivacaine: A Randomized Comparison Study. Int J Environ Res Public Health. 2022 Jan 25;19(3):1324. doi: 10.3390/ijerph19031324.

    PubMed 35162346

  • Martinus M, Mihaljevic S, Reiner K, Verzak Z, Panic MK, Strahija A, Gluncic V, Lukic IK, Lukic A. Analgesic effect of ultrasound-guided extraoral mandibular nerve block compared to intraoral conductive block of the inferior alveolar nerve after lower third molar alveolectomy: a clinical prospective study. BMC Oral Health. 2024 Sep 4;24(1):1041. doi: 10.1186/s12903-024-04787-5.

    PubMed 39232703

Questions about this trial

What is this clinical trial studying?

A study testing US guided block of mandibular nerve and Intraoral block of lower alveolar nerve in people with Molar and Impacted Teeth, run by Varazdin General Hospital at 1 site in Croatia.

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 3 inclusion and 7 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 3 Apr 2024. 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 Croatia. 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?

Time without pain (time frame: first 24 postoperative hours). 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 NCT06009302, which also lists 7 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 3 Apr 2024.

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