[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621336":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":18,"collaborators":10,"id":20,"slug":21,"hasResults":22,"nctId":23,"briefTitle":24,"officialTitle":25,"acronym":10,"eligibilityCriteria":26,"healthyVolunteers":27,"sex":28,"minAge":29,"maxAge":30,"enrollmentInfo":31,"targetDuration":10,"studyType":34,"phases":10,"briefSummary":35,"conditions":36,"keywords":39,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":10},{"fullName":5,"class":6},"Bezmialem Vakif University","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Mild Diabetic Polyneuropathy",null,"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.\n\nInterventions will be performed in the following order: thermal (cold test), electric pulp test, and masseter inhibitory reflex recording.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.",{"label":16,"type":10,"description":17,"interventionNames":10},"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.\n\nHealthy 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.",{"type":19,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100621336","pulp-sensibility-and-masseter-inhibitory-reflex-in-diabetic-polyneuropathy-100621336",false,"NCT07369297","PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY","EVALUATION OF ELECTRICAL AND THERMAL PULP SENSORY THRESHOLDS AND MASSETER INHIBITORY REFLEX RESPONSES IN PATIENTS WITH DIABETIC POLYNEUROPATHY","Inclusion Criteria:\n\nAbility to understand the study procedures and provide written informed consent.\n\nFor diabetic polyneuropathy groups:\n\n* Diagnosis of diabetic polyneuropathy confirmed by a neurologist\n* Neuropathy severity (mild or severe) determined by nerve conduction studies\n\nFor healthy control group:\n\n* No history of diabetes mellitus\n* No history of peripheral neuropathy or neurological disease\n\nPresence of at least one maxillary central incisor suitable for testing, defined as:\n\n* No previous root canal treatment\n* No extensive caries\n* No clinical or radiographic signs of periapical pathology\n* No periodontal disease affecting the selected tooth\n\nExclusion Criteria:\n\n* History of chemotherapy, head and neck radiotherapy, or systemic conditions known to affect peripheral nerve function (other than diabetic polyneuropathy in the patient groups)\n* Presence of acute or chronic orofacial pain disorders\n* Use of medications within the last 24 hours that may affect sensory perception or nerve conduction (e.g., analgesics, sedatives, neuroactive drugs)\n* History of trauma to the maxillary central incisor or surrounding tissues\n* Extensive restorations, fractures, caries, or periodontal pathology involving the selected tooth\n* Pregnancy or breastfeeding\n* Inability to tolerate study procedures or refusal to continue participation at any point",true,"ALL","25 Years","65 Years",{"count":32,"type":33},108,"ESTIMATED","OBSERVATIONAL","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.\n\nDiabetic 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.\n\nIn 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.\n\nThe 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.\n\nThe findings of this study are expected to contribute to more accurate endodontic diagnosis and improved understanding of orofacial neurophysiological changes in diabetic patients.",[37,38],"Diabetic Polyneuropathy","Healthy Individuals (Controls)",[37,40,41,42],"Electrical Pulp Test","Cold Test","Masseter Inhibitory Reflex","NOT_YET_RECRUITING","2026-04-02",{"date":46,"type":47},"2026-04-03","ACTUAL",{"date":49,"type":33},"2026-04-15",{"date":51,"type":33},"2027-01-15",{"name":5,"class":6}]