Comparing Two Anesthetic Techniques for Implant Placement

Anesthesia, Local Clinical Trial

Official title:

Prospective Randomized Multicenter Study Between Two Anesthetic Techniques for Implant Placement in the Posterior Mandible

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395690
• Other study ID #: ADA-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: Aula Dental Avanzada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Anesthesia, Local
• Dental Implant
• Edentulous Jaw
• Jaw, Edentulous

Intervention

Procedure:
• Dental Implant Placement in the posterior mandible
Surgery done in the posterior mandible with missing teeth for placing dental implants.

Locations

Country	Name	City	State
Spain	Clínica Dental Esteve	Alicante
Spain	Clinica Dental José Antonio Sánchez Nicolás	Cabezo De Torres	Alicante
Spain	TREES Clinica Dental	Cartagena
Spain	GMD Ambrosio Bernabeu	Elche	Alicante
Spain	Clínica Dental García Vega	Madrid
Spain	Salgado Dental Institute	Orihuela	Alicante
Spain	LG Dental	San Pedro del Pinatar	Murcia
Spain	Clinica Dental Amigó	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. Epub 2016 Jan 21. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Pain perceived by the patient during surgery
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	Satisfaction of the patient 12 hours after surgery.