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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01963754
Recruitment Status : Active, not recruiting
First Posted : October 16, 2013
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Implantology Institute

Study Description
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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 ?

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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)

  3. 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.

  4. 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)

  5. 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:
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963754


Locations
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Portugal
Instituto de Implantologia
Lisbon, Portugal, 1500-662
Sponsors and Collaborators
Implantology Institute
Investigators
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Principal Investigator: Andre Chen, Msc Implantology Institute
Study Director: João Caramês, Phd Implantology Institute
Study Chair: Helena Francisco, Msc Implantology Institute
Study Chair: Elena Cervino, Msc Implantology Institute
More Information
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Responsible Party: Andre Chen, Msc, Implantology Institute
ClinicalTrials.gov Identifier: NCT01963754    
Other Study ID Numbers: II-03
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andre Chen, Implantology Institute:
Articaine 1:100.000
Dental Implants
Posterior mandible
Loco-regional Anesthesia
Subperiosteal Anesthesia
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Anesthetics
Carticaine
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