N/A
N=96
Comparing Two Anesthetic Techniques for Implant Placement
Edentulous Jaw · Dental Implant · Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT04395690 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Pain Perception by Numerical Rating Scale — 0; 0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental Implant Placement in the posterior mandible (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Aula Dental Avanzada
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Perception by Numerical Rating Scale |
0; 0 | — |
| PRIMARY Satisfaction of the Patient by Numerical Rating Scale |
9; 8.8 | — |
Summary
To evaluate in a comparative way the patient's perception in implant surgery in the posterior mandibular quadrants depending on whether the operation is performed under trunk anaesthesia or infiltrative anaesthesia, in both cases with Articaine.
Randomized and multicenter prospective study to be developed in eight centers with similar socio-professional characteristics, with the same operative protocol.
A significant sample of patients will be randomized to undergo the same intervention (surgery to place implants in the posterior mandible) under one or another type of anesthesia (inferior alveolar block nerve or infiltrative) and data will be collected using a Numerical Rate scale on four occasions (after the incision, after drilling, after suturing and after 12h).
Eligibility Criteria
Inclusion Criteria
- Patient in health status American Society of Anesthesiologists (ASA) I and ASA II
- Any age and gender
- Unitary or multiple posterior mandibular edentulism.
- Need to replace at least one implant and at least 2mm distal to mental foramen
- Absence of orofacial neurological symptoms
Exclusion Criteria
- Any contraindication for implant surgery.
- Hypersensitivity to any of the products used in the study
- ASA patients ≦ II
- Pharmacological allergies that contraindicate the intervention
- Patients medicated with sedatives or analgesics up to 24h before the intervention
- Psychotropic drug abuse or medication that may alter painful perception 15 days before the intervention
- Pregnant or nursing women
- Interventions with conscious sedation
- Women on contraceptive treatment
- Bisphosphonate-treated patients
- Pathological mental state (dementia, psychosis)
- Severe dental anxiety
- Lack of collaboration
- Signs of infection in the area to be operated
- Unconventional surgical requirements (split crest, vertical regeneration, block graft, etc.)
Data sourced from ClinicalTrials.gov (NCT04395690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.