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NCT04395690

Comparing Two Anesthetic Techniques for Implant Placement

Completed NA Results posted Last updated 30 July 2024
What this trial tests

NA trial testing Dental Implant Placement in the posterior mandible in Edentulous Jaw in 96 participants. Completed in 1 July 2021.

Timeline
4 January 2019
Primary endpoint
1 July 2021
1 July 2021

Quick facts

Lead sponsorAula Dental Avanzada
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment96
Start date4 January 2019
Primary completion1 July 2021
Estimated completion1 July 2021
Sites8 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Aula Dental Avanzada

Who can join

Eligibility, any sex, with Edentulous Jaw or Dental Implant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Perception by Numerical Rating Scale Primary · Pain perceived by the patient during surgery after the incision, the osteotomy and the suture

Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain

GroupValue95% CI
Inferior Alveolar Block Nerve (IABN)00 – 0
Infiltration (INF)00 – 0
Satisfaction of the Patient by Numerical Rating Scale Primary · Satisfaction of the patient 12 hours after surgery.

Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied

GroupValue95% CI
Inferior Alveolar Block Nerve (IABN)9± 1
Infiltration (INF)8.8± 1.7

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Edentulous Jaw

Currently open trials in the same condition.

Other Aula Dental Avanzada trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04395690.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing