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Dental ImplantsNCT06641232

Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.

A study testing Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. in people with Dental Implants and Local Anesthesia, run by University of Barcelona at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this triple blind randomized clinical trial is to compare the safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implants, Local Anesthesia
What is being tested?
Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSpain
Study dates
5 Nov 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients of legal age (≥18 years), partially edentulous, requiring the placement of one or more mandibular implants in the molar area.
  • Patients without relevant systemic pathology (equal or lower than ASA II).
  • Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.

Who cannot join

  • - Pregnant patients.
  • Patients with allergy or hypersensitivity to articaine or adrenaline.
  • Patients with uncontrolled systemic diseases.
  • Patients who may recognize the anesthetic technique used (e.g. dentists).
  • Drugs or systemic diseases (ASA III or higher) that contraindicate surgical intervention or the use of anesthetics and/or vasoconstrictors.
  • Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
  • Immediate implants.
  • Surgeries requiring bone grafts.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital odontológic de Bellvitge, Universitat de Barcelona

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Official title: Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement. A Triple-blind Randomized Clinical Trial.

The goal of this triple blind randomized clinical trial is to compare the safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism.

The main questions it aims to answer are:

Read more
  • The anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area.
  • The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area.
  • The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area.

The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.

The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block.

The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch.

Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such.

  • Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the surgery will not know to which group each patient belongs.
  • The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.
Being tested
Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
Keywords
dental implants, local anesthesia, block nerve

What participants receive

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

  • Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.Procedure or surgery

    The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.

    The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.

Study groups in NCT06641232
Study groupRoleWhat they receive
Inferior dental nerve blockExperimentalOne articaine cartridge (1.8 mL of articaine 4% at 1:100,000) with the direct technique for the inferior dental nerve block and half a cartridge (0.9 mL) for the buccal nerve block.
Receives: Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.
InfiltrativeActive comparatorOne anesthetic cartridge (1.8 mL of articaine 4% 1:100,000) using the vestibular infiltrative technique (supraperiosteal paraapical). Subsequently administer half a cartridge of anesthetic (0.9 mL of articaine 4% 1:100,000) using the infiltrative technique (supraperiosteal paraapical) lingually in the sublingual area of the tooth to be treated.
Receives: Procedure: Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement.

What is being measured

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

  1. To compare the efficacy of the inferior dental nerve block and the infiltrative technique in the placement of mandibular posterior dental implants in patients with partial edentulism.

    Determined by: Reporting a negative response to the pulpometer within 6 minutes after injection. Absence of need for reanesthesia during the surgical procedure.

    Measured: 1 hour

Secondary outcomes (2)
  1. To evaluate the safety of anesthetic techniques used in the placement of dental implants in the posterior mandibular region.

    Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.

    Measured: 7 days

  2. To analyze the postoperative pain associated with the placement of mandibular implants using an inferior dental nerve block compared to those implanted with infiltrative techniques.

    Determined using a visual anlogical scale of 10 cm at the 2, 6, and 12 hours posteriors to the surgery and then everyday until the 7 days

    Measured: 7 days

Timeline

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

  1. First posted15 Oct 2024
  2. Study start5 Nov 2024
  3. Primary completion10 Jun 2026
  4. Study completionDec 2026 (estimated)

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
Randomized clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06641232
Sponsor's protocol ID
23-2024
Status last verified
May 2026
First submitted
11 Oct 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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
  • Escoda CG, Aytés LB. Tratado De Cirugia Bucal. Anim Genet. 2008;39:561-3.

  • Sancho-Puchades M, Vilchez-Perez MA, Valmaseda-Castellon E, Paredes-Garcia J, Berini-Aytes L, Gay-Escoda C. Bupivacaine 0.5% versus articaine 4% for the removal of lower third molars. A crossover randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e462-8. doi: 10.4317/medoral.17628.

    PubMed 22143739
  • Camps-Font O, Figueiredo R, Sanchez-Torres A, Cle-Ovejero A, Coulthard P, Gay-Escoda C, Valmaseda-Castellon E. Which is the most suitable local anaesthetic when inferior nerve blocks are used for impacted mandibular third molar extraction? A network meta-analysis. Int J Oral Maxillofac Surg. 2020 Nov;49(11):1497-1507. doi: 10.1016/j.ijom.2020.04.016. Epub 2020 May 27.

    PubMed 32473767
  • 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
  • Esteve-Pardo G, De-Larriva E, Salgado A, Bernabeu-Esclapez A, Bardaji JA, Esteve-Colomina L. Is Inferior Alveolar Nerve Block Needed to Perform Implant Surgery in the Posterior Mandible? A Randomized Controlled Trial. J Oral Maxillofac Surg. 2022 Mar;80(3):490-500. doi: 10.1016/j.joms.2021.09.028. Epub 2021 Oct 10.

    PubMed 34762850
  • Sanchez-Siles M, Torres-Diez LC, Camacho-Alonso F, Salazar-Sanchez N, Ballester Ferrandis JF. High volume local anesthesia as a postoperative factor of pain and swelling in dental implants. Clin Implant Dent Relat Res. 2014 Jun;16(3):429-34. doi: 10.1111/cid.12005. Epub 2012 Sep 21.

    PubMed 22998596
  • Gaffen AS, Haas DA. Retrospective review of voluntary reports of nonsurgical paresthesia in dentistry. J Can Dent Assoc. 2009 Oct;75(8):579.

    PubMed 19840499
  • Garisto GA, Gaffen AS, Lawrence HP, Tenenbaum HC, Haas DA. Occurrence of paresthesia after dental local anesthetic administration in the United States. J Am Dent Assoc. 2010 Jul;141(7):836-44. doi: 10.14219/jada.archive.2010.0281.

    PubMed 20592403
  • Haas DA, Lennon D. A 21 year retrospective study of reports of paresthesia following local anesthetic administration. J Can Dent Assoc. 1995 Apr;61(4):319-20, 323-6, 329-30.

    PubMed 7736335
  • Hillerup S, Jensen R. Nerve injury caused by mandibular block analgesia. Int J Oral Maxillofac Surg. 2006 May;35(5):437-43. doi: 10.1016/j.ijom.2005.10.004. Epub 2005 Dec 15.

    PubMed 16343853
  • Renton T, Janjua H, Gallagher JE, Dalgleish M, Yilmaz Z. UK dentists' experience of iatrogenic trigeminal nerve injuries in relation to routine dental procedures: why, when and how often? Br Dent J. 2013 Jun;214(12):633-42. doi: 10.1038/sj.bdj.2013.583.

    PubMed 23787854
  • Kim C, Hwang KG, Park CJ. Local anesthesia for mandibular third molar extraction. J Dent Anesth Pain Med. 2018 Oct;18(5):287-294. doi: 10.17245/jdapm.2018.18.5.287. Epub 2018 Oct 31.

    PubMed 30402548
  • Santos-Sanz L, Toledano-Serrabona J, Gay-Escoda C. Safety and efficacy of 4% articaine in mandibular third-molar extraction: A systematic review and meta-analysis of randomized clinical trials. J Am Dent Assoc. 2020 Dec;151(12):912-923.e10. doi: 10.1016/j.adaj.2020.08.016.

    PubMed 33228884
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Comparison of anesthetic efficacy and safety between nerve block and infiltrative technique for mandibular posterior implant placement. in people with Dental Implants and Local Anesthesia, run by University of Barcelona at 1 site 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

To compare the efficacy of the inferior dental nerve block and the infiltrative technique in the placement of mandibular posterior dental implants in patients with partial edentulism. (time frame: 1 hour). 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 NCT06641232, which also lists 19 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 6 Oct 2026.

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