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In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?
Inter/Intra observer agreement will be made for administration of local subperiosteal, loco-regional anesthesia, operatory evaluation of pain and radiologic examination.
One group will receive articaine 1:100.000, 4% epinephrine subperiosteal and the other 1:100.000 4% epinephrine loco-regional for dental implant installation in posterior mandible.
The evaluation parameters will focus on intraoperatory pain, Intraoperatory anesthetic complications, anesthetic efficiency, correlation between distance from implant to inferior alveolar nerve, intraoperatory pain, post-operatory at 3 and 10 days and correlate changes, and survival rate of dental implants during and post osseointegration period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subepriosteal Articaine | Experimental | Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible |
|
| Loco-regional Articaine | Active Comparator | Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implants in Posterior Mandible | Device | Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia efficiency | Evaluate subperiosteal vs loco-regional anesthesia for implant installation in posterior mandible. It will be measured by the amount (mean) of anesthesia pre and intraoperatory | During Surgery for Dental Implant installation |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperatory Pain | It will be measured with a direct measure composed by pre and post operatory questionnaires with Visual Analog Scales (VAS) to patient and by two indirect measures, one to the clinician that performed the surgery and one by an external clinic psychologist, both by means of VAS score | During Surgery for Implant Installation in posterior mandible |
| Measure | Description | Time Frame |
|---|---|---|
| Osseointegration | evaluate the ability of dental implants to integrate into bone, comparison between the two groups, subperiosteal vs loco-regional) | At 8 Weeks post-surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Chen, Msc | Implantology Institute | Principal Investigator |
| João Caramês, Phd | Implantology Institute | Study Director |
| Helena Francisco, Msc | Implantology Institute | Study Chair |
| Elena Cervino, Msc | Implantology Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Implantologia | Lisbon | 1500-662 | Portugal |
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|
| Subperiosteal 1:100.000 Articaine 4% epinephrine | Drug | Administration of subperiosteal anesthesia for implant placement |
|
|
| Loco-regional 1:100.000 Articaine 4% epinephrine | Drug | Administer loco-regional anesthesia for implant placement in posterior mandible |
|
|
| Intraoperatory Anesthesia Complications | measure the amount of adverse effects of both types of procedure (subperiosteal vs loco-regional) | During Surgery for implant installation in posterior mandible |
| Post-Operatory Outcome Changes | measure post-operatory magnitude changes in both groups (subperiosteal vs loco-regional anesthesia) from baseline to 10 Days. It will be measured in VAS the amount of pain experienced by the patient. | Baseline (T0) 3 Days (T1) 10 Days (T2) |
| Time of Surgery | Measure the amount of time needed to perform dental implant installation in posterior mandible in both groups (subperiosteal Vs loco-regional) | During Surgical Procedure |
| Distance To Inferior Alveolar Nerve (IAN) | measure in a panoramic (orthopantomography) the distance from the implant apex to the most coronal part of the IAN and correlate to the anesthesia efficacy and operatory pain | Post operative Panoramic radiograph |
| ID | Term |
|---|---|
| D015921 | Dental Implants |
| D002355 | Carticaine |
| D004837 | Epinephrine |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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