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

NCT ID: NCT01963754

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Surgical Complications From Local Anesthesia Dental Implant Failed Anesthesia Complications Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Subepriosteal Articaine

Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible

Group Type EXPERIMENTAL

Dental Implants in Posterior Mandible

Intervention Type DEVICE

Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations

Subperiosteal 1:100.000 Articaine 4% epinephrine

Intervention Type DRUG

Administration of subperiosteal anesthesia for implant placement

Loco-regional Articaine

Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible

Group Type ACTIVE_COMPARATOR

Dental Implants in Posterior Mandible

Intervention Type DEVICE

Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations

Loco-regional 1:100.000 Articaine 4% epinephrine

Intervention Type DRUG

Administer loco-regional anesthesia for implant placement in posterior mandible

Interventions

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Dental Implants in Posterior Mandible

Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations

Intervention Type DEVICE

Subperiosteal 1:100.000 Articaine 4% epinephrine

Administration of subperiosteal anesthesia for implant placement

Intervention Type DRUG

Loco-regional 1:100.000 Articaine 4% epinephrine

Administer loco-regional anesthesia for implant placement in posterior mandible

Intervention Type DRUG

Other Intervention Names

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Dental Fixtures Local Anesthesia Local Anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Implantology Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Chen

Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre Chen, Msc

Role: PRINCIPAL_INVESTIGATOR

Implantology Institute

João Caramês, Phd

Role: STUDY_DIRECTOR

Implantology Institute

Helena Francisco, Msc

Role: STUDY_CHAIR

Implantology Institute

Elena Cervino, Msc

Role: STUDY_CHAIR

Implantology Institute

Locations

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Instituto de Implantologia

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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II-03

Identifier Type: -

Identifier Source: org_study_id

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