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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Andre Chen, Instituto de Implantologia
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia
ClinicalTrials.gov Identifier:
NCT01963754
First received: October 12, 2013
Last updated: April 29, 2017
Last verified: April 2017
  Purpose
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 ?

Condition Intervention Phase
Surgical Complications From Local Anesthesia Dental Implant Failed Anesthesia Complications Anesthesia Morbidity Device: Dental Implants in Posterior Mandible Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine Drug: Loco-regional 1:100.000 Articaine 4% epinephrine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Andre Chen, Instituto de Implantologia:

Primary Outcome Measures:
  • Anesthesia efficiency [ Time Frame: 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:
  • Intraoperatory Pain [ Time Frame: 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 [ Time Frame: During Surgery for implant installation in posterior mandible ]
    measure the amount of adverse effects of both types of procedure (subperiosteal vs loco-regional)

  • Post-Operatory Outcome Changes [ Time Frame: 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.

  • Time of Surgery [ Time Frame: 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) [ Time Frame: 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


Other Outcome Measures:
  • Osseointegration [ Time Frame: At 8 Weeks post-surgery ]
    evaluate the ability of dental implants to integrate into bone, comparison between the two groups, subperiosteal vs loco-regional)


Estimated Enrollment: 88
Actual Study Start Date: April 1, 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dental Fixtures
Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine
Administration of subperiosteal anesthesia for implant placement
Other Name: 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 Name: Dental Fixtures
Drug: Loco-regional 1:100.000 Articaine 4% epinephrine
Administer loco-regional anesthesia for implant placement in posterior mandible
Other Name: Local Anesthesia

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963754

Contacts
Contact: André Chen, Msc 00351919774343 tsouchen@gmail.com
Contact: Elena Cervino, Msc 00351919074338 elecer@gmail.com

Locations
Portugal
Instituto de Implantologia Recruiting
Lisbon, Portugal, 1500-662
Contact: Joana Velez       joana.velez@institutodeimplantologia.com   
Principal Investigator: Andre Chen, Msc         
Principal Investigator: João Caramês, Phd         
Principal Investigator: Helena Francisco, Msc         
Sub-Investigator: Elena Cervino, Msc         
Sponsors and Collaborators
Instituto de Implantologia
Investigators
Principal Investigator: Andre Chen, Msc Instituto de Implantologia
Study Director: João Caramês, Phd Instituto de Implantologia
Study Chair: Helena Francisco, Msc Instituto de Implantologia
Study Chair: Elena Cervino, Msc Instituto de Implantologia
  More Information

Responsible Party: Andre Chen, Msc, Instituto de Implantologia
ClinicalTrials.gov Identifier: NCT01963754     History of Changes
Other Study ID Numbers: II-03
Study First Received: October 12, 2013
Last Updated: April 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andre Chen, Instituto de Implantologia:
Articaine 1:100.000
Dental Implants
Posterior mandible
Loco-regional Anesthesia
Subperiosteal Anesthesia

Additional relevant MeSH terms:
Anesthetics
Carticaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on July 21, 2017