Clinical trial NCT04395690: Comparing Two Anesthetic Techniques for Implant Placement
Official title: Prospective Randomized Multicenter Study Between Two Anesthetic Techniques for Implant Placement in the Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Dental Implant
Anesthesia, Local
Keywords: Anesthesia
Inferior Alveolar Block Nerve
Infiltration
Dental implant
Mandible
Lead sponsor: Aula Dental Avanzada
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 48 receiving infiltrative anesthesia and 48 patients receiving Inferior Alveolar Block Nerve anesthesia. (n=96)
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Pain Perception by Numerical Rating Scale
timeFrame: Pain perceived by the patient during surgery after the incision, the osteotomy and the suture
measure: Satisfaction of the Patient by Numerical Rating Scale
timeFrame: Satisfaction of the patient 12 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Cabezo De Torres
country: Spain
facility: Clinica Dental José Antonio Sánchez Nicolás
state: Alicante
city: Elche
country: Spain
facility: GMD Ambrosio Bernabeu
state: Alicante
city: Orihuela
country: Spain
facility: Salgado Dental Institute
state: Alicante
city: San Pedro del Pinatar
country: Spain
facility: LG Dental
state: Murcia
city: Alicante
country: Spain
facility: Clínica Dental Esteve
city: Cartagena
country: Spain
facility: TREES Clinica Dental
city: Madrid
country: Spain
facility: Clínica Dental García Vega
city: Valencia
country: Spain
facility: Clinica Dental Amigó
Study officials:
affiliation: Aula Dental Avanzada
name: Guillem Esteve-Pardo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.