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Alveolar Bone LossNCT05811741

Impact of Mandibular Canal Trajectory on Paresthesia After Inferior Alveolar Nerve Lateralization

An observational study of Alveolar Bone Loss and Neurosensory Disorder, run by Marmara University at 1 site in Turkey (Türkiye).

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

This prospective cohort study aims to investigate the relationship between mandibular canal trajectory and the duration of postoperative paresthesia in patients undergoing inferior alveolar nerve lateralization. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alveolar Bone Loss, Neurosensory Disorder
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2016to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Adult, Older adult

Study population: The study population consisted of consecutive patients who were treated with inferior alveolar nerve lateralization (IANL) at Marmara University Faculty of Dentistry between June 2016 and December 2022. The patients had missing teeth in the posterior region of the mandible, in whom standard or short implant placement was not possible due to mandibular atrophy.

Who may be able to join

  • Patients with atrophied posterior mandible with less than or equal to 6 mm of bone over the inferior alveolar canal
  • No previous grafting or implant surgery at the site where nerve lateralization is planned
  • No neurosensory impairment
  • No contra-indications for implant surgery

Who cannot join

  • Patients who have undergone radiotherapy in the associated area
  • Patients using bone-modifying agents
  • Smokers with daily consumption of more than ten cigarettes
  • Patients with neurosensory impairment due to trauma, tumor, or cancer

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University School of Dentistry

    Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluating the Influence of Mandibular Canal Trajectory on the Duration of Postoperative Paresthesia in Patients Undergoing Inferior Alveolar Nerve Lateralization: A Prospective Cohort Study

This prospective cohort study aims to investigate the relationship between mandibular canal trajectory and the duration of postoperative paresthesia in patients undergoing inferior alveolar nerve lateralization. The study will assess mandibular canal trajectory using anatomic factors and evaluate nerve sensory function using subjective and objective tests. Implant success criteria will also be assessed. The study will be conducted on patients who underwent IANL due to mandibular atrophy and were unable to receive standard or short implant placement. Data will be collected at regular follow-up visits up to 1-year post-surgery.

Keywords
Mandibular canal, Paresthesia, Dental implants, Survival analysis, Inferior alveolar nerve lateralization
Medical subject headings
Alveolar Bone Loss, Sensation Disorders, Paresthesia

What is being measured

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

  1. Light touch test results

    The light touch test is a common diagnostic tool used to assess sensory perception. Patients' lower lip and chin areas will be gently stroked with a soft object, such as a piece of cotton or a brush. The patients will then be asked to report their sensation. If they feel the touch, the response is considered normal. However, any reported changes, such as numbness or tingling, can indicate possible nerve damage or recovery after surgery.

    Measured: Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery

  2. 2-point discrimination test results

    The 2-point discrimination test is a neurological examination used to measure tactile spatial acuity. Two points of a caliper will be applied to the patients' lower lip and chin areas. The distance at which a patient can no longer differentiate between the two points provides an indicator of sensory nerve function. Any reported changes in the ability to distinguish between two points may suggest alterations in nerve sensitivity or recovery after surgery.

    Measured: isits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery.

Secondary outcomes (8)

  1. Thickness of the buccal cortex

    This outcome measure evaluates the thickness of the buccal cortex using radiographic measurements obtained from CBCT scans.

    Measured: At baseline

  2. Thickness of the mandibular inferior border

    This outcome measure evaluates the thickness of the mandibular inferior border using radiographic measurements obtained from CBCT scans.

    Measured: At baseline

  3. Diameter of the nerve canal

    This outcome measure evaluates the diameter of the nerve canal using radiographic measurements obtained from CBCT scans.

    Measured: At baseline

  4. Distance from the nerve canal to the buccal cortex

    This outcome measure evaluates the distance from the nerve canal to the buccal cortex using radiographic measurements obtained from CBCT scans.

    Measured: At baseline

  5. Distance from the nerve canal to the inferior border of the mandible

    This outcome measure evaluates the distance from the nerve canal to the inferior border of the mandible using radiographic measurements obtained from CBCT scans.

    Measured: At baseline

  6. Change in Implant stability quotient (ISQ) values:

    The Implant Stability Quotient (ISQ) is a metric ranging from 1 to 100 that is used to assess implant stability within the bone, with higher values indicating greater stability. To determine ISQ values, resonance frequency analysis (RFA) or sound waves are passed through a specialized peg attached to the implant.

    Measured: During implant placement and follow-up visits at 3 months.

  7. Change in peri-implant bone resorption

    This outcome measure evaluates peri-implant bone resorption using OPTG. The amount of bone loss around the implant will be assessed and recorded.

    Measured: At 3 months, and 12 months after surgery.

  8. Patient satisfaction

    This outcome measure assesses patient satisfaction using a visual analog scale. Patients will be asked to rate their satisfaction with the treatment outcome at the 12-month follow-up visit.

    Measured: At 12 month follow-up visit

Timeline

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

  1. First posted13 Apr 2023
  2. Study start1 Jun 2016
  3. Primary completion1 Dec 2021
  4. Study completion1 Apr 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811741
Sponsor's protocol ID
MUDHF_FB_006
Status last verified
Jul 2023
First submitted
1 Apr 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jung RE, Al-Nawas B, Araujo M, Avila-Ortiz G, Barter S, Brodala N, Chappuis V, Chen B, De Souza A, Almeida RF, Fickl S, Finelle G, Ganeles J, Gholami H, Hammerle C, Jensen S, Jokstad A, Katsuyama H, Kleinheinz J, Kunavisarut C, Mardas N, Monje A, Papaspyridakos P, Payer M, Schiegnitz E, Smeets R, Stefanini M, Ten Bruggenkate C, Vazouras K, Weber HP, Weingart D, Windisch P. Group 1 ITI Consensus Report: The influence of implant length and design and medications on clinical and patient-reported outcomes. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:69-77. doi: 10.1111/clr.13342.

    PubMed 30328189

  • Alling CC. Lateral repositioning of inferior alveolar neurovascular bundle. J Oral Surg. 1977 May;35(5):419. No abstract available.

    PubMed 265383

  • Jensen O, Nock D. Inferior alveolar nerve repositioning in conjunction with placement of osseointegrated implants: a case report. Oral Surg Oral Med Oral Pathol. 1987 Mar;63(3):263-8. doi: 10.1016/0030-4220(87)90187-3.

    PubMed 3473351

  • Lorean A, Kablan F, Mazor Z, Mijiritsky E, Russe P, Barbu H, Levin L. Inferior alveolar nerve transposition and reposition for dental implant placement in edentulous or partially edentulous mandibles: a multicenter retrospective study. Int J Oral Maxillofac Surg. 2013 May;42(5):656-9. doi: 10.1016/j.ijom.2013.01.020. Epub 2013 Mar 6.

    PubMed 23481542

  • Palacio Garcia-Ochoa A, Perez-Gonzalez F, Negrillo Moreno A, Sanchez-Labrador L, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM, Lopez-Quiles Martinez J. Complications associated with inferior alveolar nerve reposition technique for simultaneous implant-based rehabilitation of atrophic mandibles. A systematic literature review. J Stomatol Oral Maxillofac Surg. 2020 Sep;121(4):390-396. doi: 10.1016/j.jormas.2019.12.010. Epub 2020 Jan 2.

    PubMed 31904530

  • Kan JY, Lozada JL, Goodacre CJ, Davis WH, Hanisch O. Endosseous implant placement in conjunction with inferior alveolar nerve transposition: an evaluation of neurosensory disturbance. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):463-71.

    PubMed 9274075

  • Abayev B, Juodzbalys G. Inferior Alveolar Nerve Lateralization and Transposition for Dental Implant Placement. Part II: a Systematic Review of Neurosensory Complications. J Oral Maxillofac Res. 2015 Mar 30;6(1):e3. doi: 10.5037/jomr.2014.6103. eCollection 2015 Jan-Mar.

    PubMed 25937874

  • Lee JH, Son YJ, Hwang JH, Baek SH, Jeon JH. Influence of anatomic position and intraoperative exposure of the inferior alveolar nerve on neurosensory disturbance after sagittal split ramus osteotomy: a three-dimensional computed tomography study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Sep;122(3):300-5. doi: 10.1016/j.oooo.2016.04.008. Epub 2016 Apr 23.

    PubMed 27373586

  • Rathod M, Kshirsagar RA, Joshi S, Pawar S, Tapadiya V, Gupta S, Mahajan V. Evaluation of Neurosensory Function Following Inferior Alveolar Nerve Lateralization for Implant Placement. J Maxillofac Oral Surg. 2019 Jun;18(2):273-279. doi: 10.1007/s12663-018-1124-1. Epub 2018 Jun 2.

    PubMed 30996551

  • Zarb GA, Albrektsson T. Consensus report: towards optimized treatment outcomes for dental implants. J Prosthet Dent. 1998 Dec;80(6):641. doi: 10.1016/s0022-3913(98)70048-4. No abstract available.

    PubMed 9830066

Questions about this trial

What is this clinical trial studying?

An observational study of Alveolar Bone Loss and Neurosensory Disorder, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 4 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 10 Jul 2023. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Light touch test results (time frame: Visits at 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year after surgery). 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 NCT05811741, which also lists 10 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 10 Jul 2023.

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