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

Dental Implant Failed Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01963754
• Other study ID #: II-03
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: August 2024

Study information

• Verified date: April 2020
• Source: Instituto de Implantologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Dental Implants in Posterior Mandible
Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations

Drug:
• Subperiosteal 1:100.000 Articaine 4% epinephrine
Administration of subperiosteal anesthesia for implant placement
• Loco-regional 1:100.000 Articaine 4% epinephrine
Administer loco-regional anesthesia for implant placement in posterior mandible

Locations

Country	Name	City	State
Portugal	Instituto de Implantologia	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Implantologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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