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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during surgery | 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. | At the end of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University School of Dentistry | New Orleans | Louisiana | 70119 | United States |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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The participants will be masked to which technique they are receiving.
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 |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |