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

Phase 4UnknownNCT01963754

Implantology Institute88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Dental Implants in Posterior MandibleDEVICE

Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations

Subperiosteal 1:100.000 Articaine 4% epinephrineDRUG

Administration of subperiosteal anesthesia for implant placement

Loco-regional 1:100.000 Articaine 4% epinephrineDRUG

Administer loco-regional anesthesia for implant placement in posterior mandible

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto de Implantologia

Lisbon, Portugal

Outcomes

Primary Outcomes

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

Time frame: During Surgery for Dental Implant installation

Secondary Outcomes

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

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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