Anesthesia, Local, Dental Implant, Edentulous Jaw
Conditions
Keywords
Anesthesia, Inferior Alveolar Block Nerve, Infiltration, Dental implant, Mandible
Brief 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).
Detailed description
The optimal anesthesia for posterior mandibular implant surgery remains controversial and dependent on operator's preferences. Although not evidence-based, most operators usually avoid infiltration anesthesia in the posterior mandible due to its uncertain efficacy. However, various comparative studies with articaine 4% have not found differences between infiltration (INF) and inferior alveolar nerve block (IANB) but current research is still conflicting. Infiltration anesthesia is easier for the operator and more tolerable for the patient. Should it were sufficient for surgical procedures in the posterior mandible it could become the first option in routine surgeries. The purpose of this prospective, randomized and multicenter study is to clarify the efficacy of infiltration anesthesia for placing implants in the posterior mandible. The study will take place in eight centers with similar socio-professional characteristics and the same operative protocol. The study has been approved by the Ethical Research Committee of the University Hospital of San Juan (Alicante, Spain). On a significant sample of patients (96n) that meet the in-exclusion criteria, the same intervention (implant placement surgery in posterior area of the mandible) has been carried out randomly (List Randomizer, www.random.org/lists) with one or another type of anesthesia (group A: IANB or group B: INF). Data of pain perception from patients were collected intraoperatively, by means of a Numerical Rating Scale, in three moments (after incision, after drilling, after suturing) and global satisfaction one week post surgery. Five confounding variables were also recorded, gender, use of release incision, number of implants placed, wether or not Guided Bone Regeneration (GBR) was applied and the distance from the implant apex to the mandibular canal. A non-parametric statistical analysis was applied.
Interventions
PROCEDUREDental Implant Placement in the posterior mandible
Surgery done in the posterior mandible with missing teeth for placing dental implants.
Sponsors
Aula Dental Avanzada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients were not told what type of anesthesia was being used and surgeons obtains the method of anesthesia to be used in this particular patient thirty minutes before intervention started.
Intervention model description
48 receiving infiltrative anesthesia and 48 patients receiving Inferior Alveolar Block Nerve anesthesia. (n=96)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception by Numerical Rating Scale | 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 |
| Satisfaction of the Patient by Numerical Rating Scale | Satisfaction of the patient 12 hours after surgery. | Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied |
Countries
Spain
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 47 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Inferior Alveolar Block Nerve (IABN) | Infiltration (INF) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 8 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 39 Participants | 40 Participants |
| Pain perception | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Spain | 94 participants | 47 participants | 47 participants |
| Sex: Female, Male Female | 53 Participants | 23 Participants | 30 Participants |
| Sex: Female, Male Male | 41 Participants | 24 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Pain Perception by Numerical Rating Scale
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
Time frame: Pain perceived by the patient during surgery after the incision, the osteotomy and the suture
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inferior Alveolar Block Nerve (IABN) | Pain Perception by Numerical Rating Scale | 0 score on a scale |
| Infiltration (INF) | Pain Perception by Numerical Rating Scale | 0 score on a scale |
Primary
Satisfaction of the Patient by Numerical Rating Scale
Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied
Time frame: Satisfaction of the patient 12 hours after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inferior Alveolar Block Nerve (IABN) | Satisfaction of the Patient by Numerical Rating Scale | 9 score on a scale | Standard Deviation 1 |
| Infiltration (INF) | Satisfaction of the Patient by Numerical Rating Scale | 8.8 score on a scale | Standard Deviation 1.7 |