Comparing Two Anesthetic Techniques for Implant Placement

NCT04395690 | Completed Results

• 1 other identifier: ADA-1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 8

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).

Conditions

Edentulous Jaw; Dental Implant; Anesthesia, Local

Keywords

Anesthesia; Inferior Alveolar Block Nerve; Infiltration; Dental implant; Mandible

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Inferior Alveolar Block Nerve (IABN)

ACTIVE COMPARATOR

Inferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement.

Procedure: Dental Implant Placement in the posterior mandible

Infiltration (INF)

EXPERIMENTAL

Infiltration (INF) anesthesia technique before posterior mandibular implant placement.

Procedure: Dental Implant Placement in the posterior mandible

Interventions

Dental Implant Placement in the posterior mandible PROCEDURE

Surgery done in the posterior mandible with missing teeth for placing dental implants.

Also known as: Implant surgery

Inferior Alveolar Block Nerve (IABN); Infiltration (INF)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (8)

Clinica Dental José Antonio Sánchez Nicolás

Cabezo de Torres, Alicante, 30110, Spain

Location

GMD Ambrosio Bernabeu

Elche, Alicante, 03202, Spain

Location

Salgado Dental Institute

Orihuela, Alicante, 03189, Spain

Location

LG Dental

San Pedro del Pinatar, Murcia, 30740, Spain

Location

Clínica Dental Esteve

Alicante, 03001, Spain

Location

TREES Clinica Dental

Cartagena, 30203, Spain

Location

Clínica Dental García Vega

Madrid, 28039, Spain

Location

Clinica Dental Amigó

Valencia, 46021, Spain

Location

Related Publications (6)

• 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.

  PMID: 23527356 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.

  PMID: 23762571 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.

  PMID: 26791025 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.

  PMID: 30386507 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.

  PMID: 21196835 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.

  PMID: 12500871 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: G. Esteve-Pardo
• Organization: Aula Dental Avanzada

guillem@clinicaesteve.com

965215755

Study Officials

• Guillem Esteve-Pardo, DDS

  Aula Dental Avanzada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 48 receiving infiltrative anesthesia and 48 patients receiving Inferior Alveolar Block Nerve anesthesia. (n=96)

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 20, 2020
• Study Start: January 4, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)