Anesthesia Complications, Anesthesia Morbidity, Dental Implant Failed, Surgical Complications From Local Anesthesia
Conditions
Keywords
Articaine 1:100.000, Dental Implants, Posterior mandible, Loco-regional Anesthesia, Subperiosteal Anesthesia
Brief summary
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
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.
Interventions
DEVICEDental Implants in Posterior Mandible
Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations
DRUGSubperiosteal 1:100.000 Articaine 4% epinephrine
Administration of subperiosteal anesthesia for implant placement
DRUGLoco-regional 1:100.000 Articaine 4% epinephrine
Administer loco-regional anesthesia for implant placement in posterior mandible
Sponsors
Implantology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia efficiency | During Surgery for Dental Implant installation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperatory Pain | During Surgery for Implant Installation in posterior mandible | 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 |
| Intraoperatory Anesthesia Complications | During Surgery for implant installation in posterior mandible | measure the amount of adverse effects of both types of procedure (subperiosteal vs loco-regional) |
| Time of Surgery | During Surgical Procedure | Measure the amount of time needed to perform dental implant installation in posterior mandible in both groups (subperiosteal Vs loco-regional) |
| Distance To Inferior Alveolar Nerve (IAN) | Post operative Panoramic radiograph | 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-Operatory Outcome Changes | Baseline (T0) 3 Days (T1) 10 Days (T2) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Osseointegration | At 8 Weeks post-surgery | evaluate the ability of dental implants to integrate into bone, comparison between the two groups, subperiosteal vs loco-regional) |
Countries
Portugal
Outcome results
None listed