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

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

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 ?

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia Morbidity; Dental Implant Failed; Anesthesia Complications; Surgical Complications From Local Anesthesia
• Intervention / Treatment: Device: Dental Implants in Posterior Mandible; Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine; Drug: Loco-regional 1:100.000 Articaine 4% epinephrine

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1500-662
    • Instituto de Implantologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osseointegration	evaluate the ability of dental implants to integrate into bone, comparison between the two groups, subperiosteal vs loco-regional)	At 8 Weeks post-surgery

Collaborators and Investigators

• Sponsor: Implantology Institute
• Investigators: Principal Investigator: Andre Chen, Msc, Implantology Institute; Study Chair: Helena Francisco, Msc, Implantology Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: October 12, 2013
• First Submitted That Met QC Criteria: October 12, 2013
• First Posted (ESTIMATE): October 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Dental Implants; Loco-regional Anesthesia; Articaine 1:100.000; Posterior mandible; Subperiosteal Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Anesthetics; Epinephrine; Racepinephrine; Epinephryl borate; Carticaine
• Other Study ID Numbers: II-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No