Compare Subperiosteal and Loco-Regional Anesthesia in Posterior Mandible Dental Implant Installation

Study Overview
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Brief Summary
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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 ?

Detailed Description
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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.

Official Title
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Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial

Conditions
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Surgical Complications From Local Anesthesia, Dental Implant Failed, Anesthesia Complications, Anesthesia Morbidity

Intervention / Treatment
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* Device: Dental Implants in Posterior Mandible
* Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine
* Drug: Loco-regional 1:100.000 Articaine 4% epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single unit implant rehabilitation Maxilla and mandible Must accept treatment plan Must sign informed consent dental extraction performed at least 3 month prior Must have at least 6 mm of residual bone Absence of oral lesions keratinized tissue must be present Exclusion Criteria: If smoking and/or other drug addiction is present If local anesthetic allergy is present Patient subjected to chemical or radiotherapy if Hepatic disease is present If immunodepression is present If Pregnancy is present If Diabetes is present If Heart disease is present

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subepriosteal Articaine<br>Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible | Device: Dental Implants in Posterior Mandible<br>* Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations<br>* Other names: Dental Fixtures;Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine<br>* Administration of subperiosteal anesthesia for implant placement<br>* Other names: Local Anesthesia;|
| Active Comparator: Loco-regional Articaine<br>Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible | Device: Dental Implants in Posterior Mandible<br>* Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations<br>* Other names: Dental Fixtures;Drug: Loco-regional 1:100.000 Articaine 4% epinephrine<br>* Administer loco-regional anesthesia for implant placement in posterior mandible<br>* Other names: Local Anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Articaine 1:100.000, Dental Implants, Posterior mandible, Loco-regional Anesthesia, Subperiosteal Anesthesia