Not Yet RecruitingNot Applicable

PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY

108 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range25 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: * 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

What they're measuring

Electrical Pulp Testing Threshold

Timeframe: 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.

Trial details

NCT IDNCT07369297

SponsorBezmialem Vakif University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-15