EVALUATION OF ELECTRICAL AND THERMAL PULP SENSORY THRESHOLDS AND MASSETER INHIBITORY REFLEX RESPONSES IN PATIENTS WITH DIABETIC POLYNEUROPATHY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Electrical Pulp Testing Threshold
研究概览
简要总结
Accurate evaluation of dental pulp health is essential to avoid unnecessary endodontic treatments. In routine dental practice, pulp sensibility is commonly assessed using electric pulp testing and thermal (cold) testing. However, these tests depend on patient perception and may be influenced by various factors such as systemic diseases, nerve damage, anxiety, trauma, or medication use.
Diabetic polyneuropathy is a common complication of diabetes mellitus and may alter peripheral nerve function, potentially affecting dental pulp sensibility test responses. This clinical study aims to evaluate how the severity of diabetic polyneuropathy influences dental pulp sensibility responses and masseter inhibitory reflex (MIR) parameters. The MIR is an objective neurophysiological reflex that allows quantitative assessment of trigeminal nerve function.
In this study, individuals with mild diabetic polyneuropathy, severe diabetic polyneuropathy, and healthy controls will be evaluated. All participants will undergo electric pulp testing, cold testing, and MIR measurements using standardized protocols.
The primary hypothesis of this study is that increasing severity of diabetic polyneuropathy leads to reduced dental pulp sensibility responses and altered MIR parameters compared to healthy individuals. It is further hypothesized that conventional pulp sensibility tests may produce false-negative results in patients with advanced neuropathy.
The findings of this study are expected to contribute to more accurate endodontic diagnosis and improved understanding of orofacial neurophysiological changes in diabetic patients.
详细描述
Accurate assessment of dental pulp health is fundamental for correct endodontic diagnosis and for preventing unnecessary or inappropriate treatment decisions. In routine dental practice, pulp sensibility is commonly evaluated using electric pulp testing (EPT) and thermal (cold) testing. These methods primarily assess neural response rather than true pulp vitality and rely on patient perception, which makes them inherently subjective.
Several factors may influence pulp sensibility test outcomes, including systemic diseases affecting peripheral nerves, such as diabetic polyneuropathy, as well as trauma, anxiety levels, medication use, and metabolic disease duration. Diabetic polyneuropathy is a frequent complication of diabetes mellitus and is characterized by progressive sensory nerve dysfunction. This condition may alter trigeminal nerve conduction and pain perception, potentially leading to altered or reduced responses in conventional pulp sensibility tests and increasing the risk of false-negative results.
The masseter inhibitory reflex (MIR) is a well-established neurophysiological reflex mediated by trigeminal afferent and efferent pathways and can be objectively recorded using electromyography. Unlike conventional pulp tests, MIR provides quantitative and objective information about orofacial sensory and motor nerve function. However, the relationship between diabetic polyneuropathy severity, dental pulp sensibility responses, and MIR parameters has not been sufficiently investigated.
The aim of this clinical study is to evaluate the effect of diabetic polyneuropathy severity on dental pulp sensibility responses and masseter inhibitory reflex parameters. Individuals diagnosed with diabetic polyneuropathy who presented to the Department of Neurology at Bezmialem Vakıf University will be included and categorized into mild and severe neuropathy groups based on neurological evaluation. A healthy control group without systemic or neurological disease will also be included for comparison.
A total of 108 participants aged between 25 and 65 years will be enrolled. Demographic and clinical data including age, sex, duration of diabetes, presence of comorbid systemic diseases other than diabetes, and medication use within the last 24 hours will be recorded for all participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the study procedures and provide written informed consent.
- •For diabetic polyneuropathy groups:
- •Diagnosis of diabetic polyneuropathy confirmed by a neurologist
- •Neuropathy severity (mild or severe) determined by nerve conduction studies
- •For healthy control group:
- •No history of diabetes mellitus
- •No history of peripheral neuropathy or neurological disease
- •Presence of at least one maxillary central incisor suitable for testing, defined as:
- •No previous root canal treatment
- •No extensive caries
- •No clinical or radiographic signs of periapical pathology
- •No periodontal disease affecting the selected tooth
排除标准
- •History of chemotherapy, head and neck radiotherapy, or systemic conditions known to affect peripheral nerve function (other than diabetic polyneuropathy in the patient groups)
- •Presence of acute or chronic orofacial pain disorders
- •Use of medications within the last 24 hours that may affect sensory perception or nerve conduction (e.g., analgesics, sedatives, neuroactive drugs)
- •History of trauma to the maxillary central incisor or surrounding tissues
- •Extensive restorations, fractures, caries, or periodontal pathology involving the selected tooth
- •Pregnancy or breastfeeding
- •Inability to tolerate study procedures or refusal to continue participation at any point
研究组 & 干预措施
Mild Diabetic Polyneuropathy
The severity of diabetic polyneuropathy will be determined based on nerve conduction studies performed by the Department of Neurology. Participants will be classified into mild or severe diabetic polyneuropathy groups according to standardized nerve conduction parameters, including sensory and motor nerve conduction velocities, amplitudes, and latencies. These classifications will be made by an experienced neurologist, and group allocation will be based on objective electrophysiological findings rather than subjective symptoms.
Interventions will be performed in the following order: thermal (cold test), electric pulp test, and masseter inhibitory reflex recording.
Severe Diabetic Polyneuropathy
The severity of diabetic polyneuropathy will be determined based on nerve conduction studies performed by the Department of Neurology. Participants will be classified into mild or severe diabetic polyneuropathy groups according to standardized nerve conduction parameters, including sensory and motor nerve conduction velocities, amplitudes, and latencies. These classifications will be made by an experienced neurologist, and group allocation will be based on objective electrophysiological findings rather than subjective symptoms. Interventions will be performed in the following order: thermal (cold test), electric pulp test, and masseter inhibitory reflex recording.
Healthy Controls Group
The healthy control group will consist of individuals with no history of diabetes mellitus, peripheral neuropathy, or any other systemic or neurological disease. Control participants will have no history of chemotherapy, chronic pain disorders, or conditions known to affect peripheral nerve function. Individuals using medications that may influence sensory perception or nerve conduction within the last 24 hours will be excluded.
Healthy controls will undergo the same standardized examination protocol as the diabetic polyneuropathy groups, including thermal (cold) testing, electric pulp testing, and masseter inhibitory reflex (MIR) recording, performed in the same fixed order. The same tooth selection criteria will be applied, and all procedures will be conducted under identical conditions to allow reliable comparison between groups.
结局指标
主要结局
Electrical Pulp Testing Threshold
时间窗: The total duration of the EPT procedure is expected to be approximately 2-3 minutes per participant, including tooth isolation, probe placement, gradual increase of electrical stimulus intensity, and recording of the response threshold.
Electric pulp sensibility will be evaluated using a standardized electric pulp test (EPT) performed on the maxillary central incisor. The tooth will be isolated and dried, and a conductive medium will be applied to ensure proper electrical contact. The EPT probe will be placed on the mid-facial surface of the tooth, and electrical stimulus intensity will be gradually increased according to the manufacturer's instructions. Participants will be instructed to indicate the first sensation perceived during stimulation. The stimulus will be stopped immediately upon participant response. The response threshold will be recorded as a numerical value on a standardized scale ranging from 0 to 64. The test will be repeated after a short recovery period if necessary to confirm reproducibility.
次要结局
- Time to First Sensation During Thermal (cold) Pulp Sensibility Test(The thermal (cold) pulp sensibility test will require approximately 2-3 minutes, including tooth isolation, application of the cold stimulus, and recording of response times.)
- Time to Disappearance of Sensation After Thermal (cold) Stimulus Removal(The thermal (cold) pulp sensibility test will require approximately 2-3 minutes, including tooth isolation, application of the cold stimulus, and recording of response times.)
- Masseter Inhibitory Reflex Latency(The total duration of MIR recording, including electrode placement, calibration, and electromyographic data acquisition, is expected to be approximately 10-15 minutes per participant.)
- Masseter Inhibitory Reflex Silent Period Duration(The total duration of MIR recording, including electrode placement, calibration, and electromyographic data acquisition, is expected to be approximately 10-15 minutes per participant.)