Clinical trial NCT05659069: Influence of Mandibular Nerve Lateralization on Nutrition and Speech
Official title: The Effect of Inferior Alveolar Nerve Lateralization on Nutritional Status, Masticatory Performance and Speech; Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alveolar Bone Loss
Bone Deformity
Keywords: Dental implants
Mandibular nerve
Nutritional status
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with missing teeth in the posterior mandibular region and planned dental implant construction will constitute the study population.

Brief summary: This study aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. The control group will include patients with standard implant placement in the mandibular posterior region. The test group will consist of patients with implant placement in the mandibular posterior region with inferior alveolar nerve lateralization. The patients will be evaluated before implant surgery and followed up for four months until the final prosthesis is placed. Changes in nutritional status, masticatory performance and speech abilities will be assessed during this process.


Eligibility criteria: Inclusion Criteria:

* A standard dental implant with or without lateralization of the inferior alveolar nerve in the posterior region of the mandible at the Marmara University Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery clinic.
* The patient accepted to participate in the study and gave written/verbal consent

Exclusion Criteria:

* Dental implant placement in the posterior region of the mandible with additional surgical methods (onlay/inlay graft, directed tissue regeneration, etc.) other than nerve lateralization.
* Patients had a neurosensory disorder in the maxillofacial region before implant surgery

Primary outcomes:
measure: Change from baseline in a neurosensory disturbance with a two-point discrimination test
timeFrame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in lip sensitivity pattern with semmes-weinstein monofilament test
timeFrame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in nutritional status
timeFrame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change in acoustic characteristics of speech
timeFrame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary outcomes:
measure: Change from baseline in the masticatory performance
timeFrame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in body weight
timeFrame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in food consumption
timeFrame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in depression test
timeFrame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
measure: Change from baseline in observational assessment of chewing
timeFrame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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