Clinical trial NCT01963754: Compare Subperiosteal and Loco-Regional Anesthesia in Posterior Mandible Dental Implant Installation
Official title: Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Complications From Local Anesthesia
Dental Implant Failed
Anesthesia Complications
Anesthesia Morbidity
Keywords: Articaine 1:100.000
Dental Implants
Posterior mandible
Loco-regional Anesthesia
Subperiosteal Anesthesia
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anesthesia efficiency
timeFrame: During Surgery for Dental Implant installation
Secondary outcomes:
measure: Intraoperatory Pain
timeFrame: During Surgery for Implant Installation in posterior mandible
measure: Intraoperatory Anesthesia Complications
timeFrame: During Surgery for implant installation in posterior mandible
measure: Post-Operatory Outcome Changes
timeFrame: Baseline (T0) 3 Days (T1) 10 Days (T2)
measure: Time of Surgery
timeFrame: During Surgical Procedure
measure: Distance To Inferior Alveolar Nerve (IAN)
timeFrame: Post operative Panoramic radiograph
Other outcomes:
measure: Osseointegration
timeFrame: At 8 Weeks post-surgery
Locations:
city: Lisbon
country: Portugal
facility: Instituto de Implantologia
Study officials:
affiliation: Implantology Institute
name: Andre Chen, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Implantology Institute
name: João Caramês, Phd
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Helena Francisco, Msc
role: STUDY_CHAIR
affiliation: Implantology Institute
name: Elena Cervino, Msc
role: STUDY_CHAIR
References: