Clinical Trial

PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY

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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-18.
Trial Details
NCT Number NCT07369297
Lead Sponsor Bezmialem Vakif University
Conditions Diabetic Polyneuropathy, Healthy Individuals (Controls)
Enrollment 108 participants
Start Date 2026-04-15
Primary Completion 2026-09-15 (estimated)
Study Completion 2027-01-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-03