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

NCT01963754 | Unknown Phase 4 DMC

• 1 other identifier: II-03
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 ?

Conditions

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

Keywords

Articaine 1:100.000; Dental Implants; Posterior mandible; Loco-regional Anesthesia; Subperiosteal Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intraoperatory Pain

  During Surgery for Implant Installation in posterior mandible

• Intraoperatory Anesthesia Complications

  During Surgery for implant installation in posterior mandible

• Post-Operatory Outcome Changes

  Baseline (T0) 3 Days (T1) 10 Days (T2)

• Time of Surgery

  During Surgical Procedure

• Distance To Inferior Alveolar Nerve (IAN)

  Post operative Panoramic radiograph

Other Outcomes (1)

• Osseointegration

  At 8 Weeks post-surgery

Study Arms (2)

Subepriosteal Articaine

EXPERIMENTAL

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

Device: Dental Implants in Posterior Mandible; Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine

Loco-regional Articaine

ACTIVE COMPARATOR

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

Device: Dental Implants in Posterior Mandible; Drug: Loco-regional 1:100.000 Articaine 4% epinephrine

Interventions

Dental Implants in Posterior Mandible DEVICE

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

Also known as: Dental Fixtures

Loco-regional Articaine; Subepriosteal Articaine

Subperiosteal 1:100.000 Articaine 4% epinephrine DRUG

Administration of subperiosteal anesthesia for implant placement

Also known as: Local Anesthesia

Subepriosteal Articaine

Loco-regional 1:100.000 Articaine 4% epinephrine DRUG

Administer loco-regional anesthesia for implant placement in posterior mandible

Also known as: Local Anesthesia

Loco-regional Articaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Instituto de Implantologia

Lisbon, 1500-662, Portugal

Location

MeSH Terms

Interventions

Dental Implants; Carticaine; Epinephrine; Anesthesia, Local

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Andre Chen, Msc

  Implantology Institute

  PRINCIPAL INVESTIGATOR

• João Caramês, Phd

  Implantology Institute

  STUDY DIRECTOR

• Helena Francisco, Msc

  Implantology Institute

  STUDY CHAIR

• Elena Cervino, Msc

  Implantology Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: October 12, 2013
• First Posted: October 16, 2013
• Study Start: April 1, 2017
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)