Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inferior Alveolar Block Nerve (IABN) | Active Comparator | Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement. |
|
| Infiltration (INF) | Experimental | Infiltration (INF) anesthesia technique before posterior mandibular implant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant Placement in the posterior mandible | Procedure | Surgery done in the posterior mandible with missing teeth for placing dental implants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pain perceived by the patient during surgery after the incision, the osteotomy and the suture |
| Satisfaction of the Patient by Numerical Rating Scale | Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied | Satisfaction of the patient 12 hours after surgery. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillem Esteve-Pardo, DDS | Aula Dental Avanzada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dental José Antonio Sánchez Nicolás | Cabezo de Torres | Alicante | 30110 | Spain | ||
| GMD Ambrosio Bernabeu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23527356 | Background | Kim S, Lee YJ, Lee S, Moon HS, Chung MK. Assessment of pain and anxiety following surgical placement of dental implants. Int J Oral Maxillofac Implants. 2013 Mar-Apr;28(2):531-5. doi: 10.11607/jomi.2713. | |
| 23762571 | Background | Alghamdi AS. Pain sensation and postsurgical complications in posterior mandibular implant placement using ridge mapping, panoramic radiography, and infiltration anesthesia. ISRN Dent. 2013 May 21;2013:134210. doi: 10.1155/2013/134210. Print 2013. |
Not provided
Not provided
No plan to share with other researches.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible participants were adult patients of any age and gender, in health status ASA I or ASA II, with posterior mandibular edentulism, requiring to replace at least one implant and at least 2 mm distal to mental foramen (in positions 45, 46, 47, 35, 36, 37, according to the FDI notation) and without contraindication for implant surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | 95% Confidence Interval | score on a scale | Pain perceived by the patient during surgery after the incision, the osteotomy and the suture |
|
7 days
Other (Not Including Serious) such as inferior alveolar nerve injury or local anesthetic toxicity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G. Esteve-Pardo | Aula Dental Avanzada | 965215755 | guillem@clinicaesteve.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2019 | May 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2019 | Jan 6, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
Not provided
Not provided
48 receiving infiltrative anesthesia and 48 patients receiving Inferior Alveolar Block Nerve anesthesia. (n=96)
Not provided
Not provided
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.
|
| Elche |
| Alicante |
| 03202 |
| Spain |
| Salgado Dental Institute | Orihuela | Alicante | 03189 | Spain |
| LG Dental | San Pedro del Pinatar | Murcia | 30740 | Spain |
| Clínica Dental Esteve | Alicante | 03001 | Spain |
| TREES Clinica Dental | Cartagena | 30203 | Spain |
| Clínica Dental García Vega | Madrid | 28039 | Spain |
| Clinica Dental Amigó | Valencia | 46021 | Spain |
| 26791025 | Background | Bataineh AB, Alwarafi MA. Patient's pain perception during mandibular molar extraction with articaine: a comparison study between infiltration and inferior alveolar nerve block. Clin Oral Investig. 2016 Nov;20(8):2241-2250. doi: 10.1007/s00784-016-1712-8. Epub 2016 Jan 21. |
| 30386507 | Background | Garcia-Blanco M, Gualtieri AF, Puia SA. A randomized controlled trial comparing nerve block and mandibular infiltration techniques in posterior mandible implant surgeries. J Clin Exp Dent. 2018 Oct 1;10(10):e1003-e1010. doi: 10.4317/jced.54330. eCollection 2018 Oct. |
| 21196835 | Background | Etoz OA, Er N, Demirbas AE. Is supraperiosteal infiltration anesthesia safe enough to prevent inferior alveolar nerve during posterior mandibular implant surgery? Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e386-9. doi: 10.4317/medoral.16.e386. |
| 12500871 | Background | Heller AA, Shankland WE 2nd. Alternative to the inferior alveolar nerve block anesthesia when placing mandibular dental implants posterior to the mental foramen. J Oral Implantol. 2001;27(3):127-33. doi: 10.1563/1548-1336(2001)0272.3.CO;2. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain perception | Patients' perceived pain by a numerical rating scale (NRS). | Median | Inter-Quartile Range | units 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 | Posted | Mean | Standard Deviation | score on a scale | Satisfaction of the patient 12 hours after surgery. |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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. | 0 | 47 | 0 | 47 | 0 | 47 |
Not provided
Not provided
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |