The Effect of Inferior Alveolar Nerve Lateralization on Nutritional Status, Masticatory Performance and Speech; Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in a neurosensory disturbance with a two-point discrimination test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in a neurosensory disturbance with a two-point discrimination test
时间窗: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Using a calliper, this test will be carried out. Care should be given to ensure that both calliper tips are touching the lower lip simultaneously until the patient can distinguish between two points of contact, at which point the distance between the two points is noted.
Change from baseline in nutritional status
时间窗: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
The Subjective Global Assessment (SGA) will be used to assess changes in nutritional status. SGA is an easy-to-apply, a low-cost and reliable method frequently used to evaluate malnutrition status. After the patient is assessed according to specific criteria, the level of malnutrition is determined by the evaluator's subjective point of view. It is a four-part evaluation. These are weight loss and food intake history, gastrointestinal system symptoms, functional capacity, metabolic requirements, and physical examination. The analysis of the information and the results from it are scored as A, B, C. If the patient is well-nourished, he is classified as A, moderately malnourished, B, and severely malnourished, C. SGA will be applied by the researchers in face-to-face meetings.
Change in acoustic characteristics of speech
时间窗: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
PRAAT software will be used for scientific analysis of speech and phonetics. In our study, the acoustic properties of speech will be recorded and compared with the help of PRAAT before and after the implant, and it will be examined whether these properties have changed or not. Pitch characteristics, jitter values, shimmer values, intensities and speech breaks, if any, will be observed. Shimmer (dB): Shimmer is a parameter that shows the relative change between the sound wave amplitudes at short intervals. The peak amplitude of each period is compared with the peak amplitude of the next period, and shimmer can be calculated in dB. Jitter: Jitter is the parameter that shows the variability of the vibratory cycle frequency with respect to the subsequent cycle frequency.
Change from baseline in lip sensitivity pattern with semmes-weinstein monofilament test
时间窗: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Mapping of the Semmes-Weinstein monofilament pressure thresholds in the lower lip's predetermined regions.
次要结局
- Change from baseline in the masticatory performance(Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.)
- Change from baseline in observational assessment of chewing(Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.)
- Change from baseline in body weight(Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.)
- Change from baseline in depression test(Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.)
- Change from baseline in food consumption(Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.)
研究者
Ferit Bayram
Assist. Prof.
Marmara University