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Efficacy of Vitamin B Complex in the Recovery of Inferior Alveolar Nerve Paresthesia
NCT07592897Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Primary completion
- Nov 2026
- Sponsor
- Universidade de São Paulo
- Modality
- Small Molecules
- Drugs
- Compound Vitamin B
- Conditions
- paresthesiaHypoesthesia ((none))
01
Overview
Phase 4, randomised, double-blind trial of Compound Vitamin B in paresthesia and Hypoesthesia ((none)) (2 arms), sponsored by Universidade de São Paulo. Primary endpoint: Static Two-Point Discrimination Threshold at 8 weeks. Planned start Jun 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vitamin B Complex
One oral capsule taken daily for 56 days (8 weeks).
Placebo
One oral capsule taken daily for 56 days (8 weeks).
03
Who it enrols
Adults aged 18-70 with paresthesia of the inferior alveolar nerve following mandibular third molar extraction, with symptom onset 7-30 days prior to screening, excluding those with allergies to vitamin B complex or taking other neurotropic agents.
04
Endpoints
Primary
Static Two-Point Discrimination Threshold
Secondary
Semmes-Weinstein Monofilament Threshold
Visual Analog Scale
Pinprick Sensation Category
Thermal Sensation Accuracy
Proportion of Participants Achieving Clinically Meaningful Improvement
Global Perception of Change
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