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Edentulous JawNCT04395690

Comparing Two Anesthetic Techniques for Implant Placement

A study testing Dental Implant Placement in the posterior mandible in people with Edentulous Jaw and Dental Implant, run by Aula Dental Avanzada at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Edentulous Jaw, Dental Implant, Anesthesia, Local
What is being tested?
Dental Implant Placement in the posterior mandible
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
8 sitesSpain
Study dates
4 Jan 2019to 1 Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Clínica Dental Esteve

    Alicante, 03001

  • Clinica Dental José Antonio Sánchez Nicolás

    Cabezo de Torres, Alicante, 30110

  • TREES Clinica Dental

    Cartagena, 30203

  • GMD Ambrosio Bernabeu

    Elche, Alicante, 03202

  • Clínica Dental García Vega

    Madrid, 28039

  • Salgado Dental Institute

    Orihuela, Alicante, 03189

  • LG Dental

    San Pedro del Pinatar, Murcia, 30740

  • Clinica Dental Amigó

    Valencia, 46021

Other trials in Spain

About this study

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

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).

Read the 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.

Being tested
Dental Implant Placement in the posterior mandible
Keywords
Anesthesia, Inferior Alveolar Block Nerve, Infiltration, Dental implant, Mandible
Medical subject headings
Jaw, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental Implant Placement in the posterior mandibleProcedure or surgery

    Also called Implant surgery

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

Study groups in NCT04395690
Study groupRoleWhat they receive
Inferior Alveolar Block Nerve (IABN)Active comparatorInferior Alveolar Block Nerve (IABN) anesthesia technique before posterior mandibular implant placement.
Receives: Procedure: Dental Implant Placement in the posterior mandible
Infiltration (INF)ExperimentalInfiltration (INF) anesthesia technique before posterior mandibular implant placement.
Receives: Procedure: Dental Implant Placement in the posterior mandible

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pain perceived by the patient during surgery after the incision, the osteotomy and the suture

  2. Satisfaction of the Patient by Numerical Rating Scale

    Patients satisfaction 12 hours after operation, being 0 not satisfied at all, and 10 very satisfied

    Measured: Satisfaction of the patient 12 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start4 Jan 2019
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
48 receiving infiltrative anesthesia and 48 patients receiving Inferior Alveolar Block Nerve anesthesia. (n=96)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395690
Sponsor's protocol ID
ADA-1
Status last verified
Jul 2024
First submitted
12 May 2020
Last updated
30 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share with other researches.

Publications

  • 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.

    PubMed 23527356

  • 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.

    PubMed 23762571

  • 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.

    PubMed 26791025

  • 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.

    PubMed 30386507

  • 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.

    PubMed 21196835

  • 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.

    PubMed 12500871

Questions about this trial

What is this clinical trial studying?

A study testing Dental Implant Placement in the posterior mandible in people with Edentulous Jaw and Dental Implant, run by Aula Dental Avanzada at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Perception by Numerical Rating Scale (time frame: Pain perceived by the patient during surgery after the incision, the osteotomy and the suture). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04395690, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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