Trial Outcomes & Findings for Comparing Two Anesthetic Techniques for Implant Placement (NCT NCT04395690)

Last Updated: 2024-07-30

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

Pain perceived by the patient during surgery after the incision, the osteotomy and the suture

Results posted on

2024-07-30

Participant Flow

The study population was composed by all patients scheduled for the placement of implants in the area distal to the mental foramen, in each of the 8 participating centers, between January 4, 2019 and March 7, 2021.

Two patients, 1 of each group, out of the initial 96 included in the study, had to be excluded from the analysis classified as "anesthetic failures". In the IANB group, 1 nerve block resulted in being ineffective and the operator had to use an intraosseous technique. In the INF group, 1 patient needed additional injections to continue the surgery and was also excluded.

Participant milestones

Participant milestones
Measure	Inferior Alveolar Block Nerve (IABN) Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Infiltration (INF) Infiltration (INF) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.
Overall Study STARTED	48	48
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Inferior Alveolar Block Nerve (IABN) Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Infiltration (INF) Infiltration (INF) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inferior Alveolar Block Nerve (IABN) n=47 Participants Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Infiltration (INF) n=47 Participants Infiltration (INF) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=47 Participants	0 Participants n=47 Participants	0 Participants n=94 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=47 Participants	40 Participants n=47 Participants	79 Participants n=94 Participants
Age, Categorical >=65 years	8 Participants n=47 Participants	7 Participants n=47 Participants	15 Participants n=94 Participants
Sex: Female, Male Female	23 Participants n=47 Participants	30 Participants n=47 Participants	53 Participants n=94 Participants
Sex: Female, Male Male	24 Participants n=47 Participants	17 Participants n=47 Participants	41 Participants n=94 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	47 participants n=47 Participants	47 participants n=47 Participants	94 participants n=94 Participants
Pain perception	0 units on a scale n=47 Participants	0 units on a scale n=47 Participants	0 units on a scale n=94 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Inferior Alveolar Block Nerve (IABN) n=47 Participants Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Infiltration (INF) n=47 Participants Infiltration (INF) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.
Pain Perception by Numerical Rating Scale	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Satisfaction of the patient 12 hours after surgery.

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

Outcome measures

Outcome measures
Measure	Inferior Alveolar Block Nerve (IABN) n=47 Participants Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.	Infiltration (INF) n=47 Participants Infiltration (INF) anesthesia technique before posterior mandibular implant placement. Dental Implant Placement in the posterior mandible: Surgery done in the posterior mandible with missing teeth for placing dental implants.
Satisfaction of the Patient by Numerical Rating Scale	9 score on a scale Standard Deviation 1	8.8 score on a scale Standard Deviation 1.7

Adverse Events

Inferior Alveolar Block Nerve (IABN)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infiltration (INF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

G. Esteve-Pardo

Aula Dental Avanzada

Phone: 965215755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place