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Completed

NCT Number: NCT05406895

Use of CBCT to Improve Inferior Alveolar Nerve Block Success

The study looks to compare the success rate of lower jaw anesthesia injection (inferior alveolar nerve) that is guided by pre-treatment 3D dental scan (CBCT) versus standard injection technique.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana State University School of Dentistry

New Orleans, Louisiana, 70119, United States

About this study

A total of 200 participants will be recruited that have existing 3D dental scans (CBCT) and require an implant placement (that will be placed in a two stage procedure) in the lower jaw for which a lower jaw anesthesia injection (inferior alveolar nerve) block will be used. The participants will be randomly assigned into one of two groups. The first group will receive the injection technique that is guided by pre-treatment measurements made from the 3D dental scan (CBCT) during implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. The second group will receive the standard injection technique first at the implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the injection technique guided by the 3D dental scan (CBCT). If the implant is placed as a one-stage procedure, the second visit will not apply. Following this, subjective and objective measurements on the success of the anesthesia will be measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female patients from the age 18 to 70 years old that are assigned to the 3 clinicians of the graduating class of LSUHSC School of Dentistry Post-graduate Periodontics program.
  • Patients have been reported as an ASA I or ASA II patient that has never had an allergic reaction to lidocaine based on previous dental experience.
  • The patient must be missing one or more mandibular teeth and is treatment planned for a mandibular implant that is placed that requires an inferior alveolar nerve block during surgery.
  • Patient must have an existing CBCT scan within the last year or is planned for a CBCT scan for the purpose of dental implant treatment.

Exclusion criteria

  • The exclusion criteria include patients that have undergone long term use or continuous use within the last week of opioids, analgesics, medications of nerve related pathology and non-steroidal anti-inflammatory drugs.
  • Patients diagnosed with trismus.
  • Patients that request for Nitrous and IV anesthesia
  • Patients missing remaining teeth in the quadrant or having a history of endodontic treatment of the remaining teeth in the quadrant.
  • Patients having endodontic or pulpal pathology in the teeth in the quadrant.

Treatment and study plan

2% lidocaine with 1:100,000 epinephrine

Drug

2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block).

Primary outcomes

  1. Lingual nerve numbness

    Time frame: 3 minutes

    Numbness of tongue, numbness of lingual tissue

  2. Lingual nerve numbness

    Time frame: 5 minutes

    Numbness of tongue, numbness of lingual tissue

  3. Lingual nerve numbness

    Time frame: 8 minutes

    Numbness of tongue, numbness of lingual tissue

  4. Lingual nerve numbness

    Time frame: 10 minutes

    Numbness of tongue, numbness of lingual tissue

  5. Lingual nerve numbness

    Time frame: one hour

    Numbness of tongue, numbness of lingual tissue

  6. Lingual nerve numbness

    Time frame: 2 hours

    Numbness of tongue, numbness of lingual tissue

  7. Mental nerve numbness

    Time frame: 3 minutes

    Numbness of lips, numbness of buccal gingival tissue of canine

  8. Mental nerve numbness

    Time frame: 5 minutes

    Numbness of lips, numbness of buccal gingival tissue of canine

  9. Mental nerve numbness

    Time frame: 8 minutes

    Numbness of lips, numbness of buccal gingival tissue of canine

  10. Mental nerve numbness

    Time frame: 10 minutes

    Numbness of lips, numbness of buccal gingival tissue of canine

  11. Mental nerve numbness

    Time frame: 1 hour

    Numbness of lips, numbness of buccal gingival tissue of canine

  12. Mental nerve numbness

    Time frame: 2 hours

    Numbness of lips, numbness of buccal gingival tissue of canine

  13. Inferior alveolar nerve numbness

    Time frame: 3 minutes

    Numbness of buccal gingival tissue of molar

  14. Inferior alveolar nerve numbness

    Time frame: 5 minutes

    Numbness of buccal gingival tissue of molar

  15. Inferior alveolar nerve numbness

    Time frame: 8 minutes

    Numbness of buccal gingival tissue of molar

  16. Inferior alveolar nerve numbness

    Time frame: 10 minutes

    Numbness of buccal gingival tissue of molar

  17. Inferior alveolar nerve numbness

    Time frame: 1 hour

    Numbness of buccal gingival tissue of molar

  18. Inferior alveolar nerve numbness

    Time frame: 2 hours

    Numbness of buccal gingival tissue of molar

  19. Inferior alveolar nerve numbness

    Time frame: 3 minutes

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

  20. Inferior alveolar nerve numbness

    Time frame: 5 minutes

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

  21. Inferior alveolar nerve numbness

    Time frame: 8 minutes

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

  22. Inferior alveolar nerve numbness

    Time frame: 10 minutes

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

  23. Inferior alveolar nerve numbness

    Time frame: 1 hour

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

  24. Inferior alveolar nerve numbness

    Time frame: 2 hours

    Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

Secondary outcomes

  1. Pain during surgery

    Time frame: At the end of the procedure

    Pain during surgery will be measured using Visual Analog Scale (VAS) which is a linear scale from 0-100 with a lower number suggesting a more successful anesthesia.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2022
Registry last updated
May 3, 2024

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.

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