Compare Subperiosteal and Loco-Regional Anesthesia in Posterior Mandible Dental Implant Installation
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| 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 Names:
Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine
Administration of subperiosteal anesthesia for implant placement
Other Names:
|
| 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 Names:
Drug: Loco-regional 1:100.000 Articaine 4% epinephrine
Administer loco-regional anesthesia for implant placement in posterior mandible
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Anesthesia efficiency [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 [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 [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 [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 [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) [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 [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
Criteria
Inclusion Criteria:
-
Single unit implant rehabilitation
-
Maxilla and mandible
-
Must accept treatment plan
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Must sign informed consent
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dental extraction performed at least 3 month prior
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Must have at least 6 mm of residual bone
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Absence of oral lesions
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keratinized tissue must be present
Exclusion Criteria:
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If smoking and/or other drug addiction is present
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If local anesthetic allergy is present
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Patient subjected to chemical or radiotherapy
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if Hepatic disease is present
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If immunodepression is present
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If Pregnancy is present
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If Diabetes is present
-
If Heart disease is present
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Implantologia | Lisbon | Portugal | 1500-662 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- II-03