NCT05406895

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

May 27, 2022

Last Update Submit

May 1, 2024

Conditions

Inferior Alveolar NerveMandibular Nerve Blocks

Outcome Measures

Primary Outcomes (24)

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    3 minutes

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    5 minutes

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    8 minutes

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    10 minutes

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    one hour

  • Lingual nerve numbness

    Numbness of tongue, numbness of lingual tissue

    2 hours

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    3 minutes

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    5 minutes

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    8 minutes

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    10 minutes

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    1 hour

  • Mental nerve numbness

    Numbness of lips, numbness of buccal gingival tissue of canine

    2 hours

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    3 minutes

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    5 minutes

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    8 minutes

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    10 minutes

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    1 hour

  • Inferior alveolar nerve numbness

    Numbness of buccal gingival tissue of molar

    2 hours

  • Inferior alveolar nerve numbness

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

    3 minutes

  • Inferior alveolar nerve numbness

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

    5 minutes

  • Inferior alveolar nerve numbness

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

    8 minutes

  • Inferior alveolar nerve numbness

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

    10 minutes

  • Inferior alveolar nerve numbness

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

    1 hour

  • Inferior alveolar nerve numbness

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

    2 hours

Secondary Outcomes (1)

  • Pain during surgery

    At the end of the procedure

Study Arms (2)

CBCT first

EXPERIMENTAL

This 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 the implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. If the implant is placed as a one-stage procedure, the second visit will not apply.

Drug: 2% Lidocaine with 1:100,000 epinephrine

Standard technique first

ACTIVE COMPARATOR

This group will receive the standard injection technique first at the implant placement surgery and if the 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.

Drug: 2% Lidocaine with 1:100,000 epinephrine

Interventions

2% Lidocaine with 1:100,000 epinephrineDRUG

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

CBCT firstStandard technique first

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Interventions

LidocaineEpinephrine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be masked to which technique they are receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel model for either CBCT guided or intra-oral technique. If the patients receive a two-stage implant placement technique then a cross-over model will be used.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 7, 2022

Study Start

May 25, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)