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

Phase 4

• Conditions: Surgical Complications From Local Anesthesia; Anesthesia Complications; Anesthesia Morbidity; Dental Implant Failed
• Interventions: Device: Dental Implants in Posterior Mandible

• Registration Number: NCT01963754
• Lead Sponsor: Implantology Institute

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.

Study Timeline

• Study First Submitted: 2013-10-12
• Study First Submitted QC: 2013-10-12
• Study First Posted: 2013-10-16
• Study Start: 2017-04-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-21
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subepriosteal Articaine	Dental Implants in Posterior Mandible	Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible
Loco-regional Articaine	Dental Implants in Posterior Mandible	Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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.

Trial Locations

Locations (1)

Instituto de Implantologia; 🇵🇹 Lisbon, Portugal