Vitamin B Complex for Inferior Alveolar Nerve Paresthesia Recovery

NCT07592897 | Not Yet Recruiting Phase 4

• 2 other identifiers: 2025-727194630525.7.0000.0075
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Why is this study being done? Paresthesia is a change in sensation that can cause numbness, tingling, or loss of feeling in a part of the body. This condition can occur after dental procedures such as wisdom tooth (third molar) extraction, dental implant placement, or jaw surgery. When this happens, the inferior alveolar nerve - which is responsible for sensation in the lower lip, chin, and gum area on the side of the jaw - may be injured. This can affect a person's quality of life, making everyday activities like eating, drinking, speaking, and even smiling feel different or uncomfortable. What is being studied? This study is testing whether taking B vitamins (vitamin B complex) can help the inferior alveolar nerve recover faster and more completely compared to a placebo (an inactive pill that looks the same but contains no active medicine). B vitamins - especially B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin) - are known to play important roles in nerve health, including helping repair damaged nerves and maintaining the protective covering around nerves called myelin. Who can participate? Adults between 18 and 70 years old who have numbness or altered sensation in the lower lip, chin, or gum area caused by damage to the inferior alveolar nerve following a dental procedure (specifically wisdom tooth extraction), and whose symptoms began between 7 and 30 days ago. What will happen in the study? Participants will be randomly assigned (like flipping a coin) to one of two groups: Vitamin B complex group: Takes one capsule daily containing B vitamins Placebo group: Takes one identical-looking capsule daily with no active ingredients Neither the participants nor the doctors performing the sensory tests will know which group they are in. This is called a "blinded" study and helps ensure the results are reliable. Participants will attend 6 scheduled visits over 8 weeks: T0 (baseline): Initial sensory testing, questionnaires, and receiving the study medication T1 (1 week): Follow-up sensory testing T2 (2 weeks): Follow-up sensory testing T3 (4 weeks): Follow-up sensory testing T4 (6 weeks): Follow-up sensory testing T5 (8 weeks): Final sensory testing and end of study participation At each visit, researchers will perform simple, non-invasive tests to measure sensation in the affected area, including: Light touch tests with soft nylon filaments (monofilaments) Two-point discrimination (testing the ability to feel one or two points touching the skin) Pinprick sensation (testing sharp touch) Temperature sensation (warm and cold) Visual Analog Scale (VAS) where participants rate their sensation on a scale What are the possible benefits? Participants who receive the vitamin B complex may experience faster or more complete recovery of sensation in their lower lip, chin, or gum area. Even those in the placebo group may experience some improvement due to the body's natural healing process. All participants will receive close monitoring of their nerve function over 8 weeks. What are the possible risks? The risks are considered low. B vitamins are generally safe at the doses used in this study. Some people may experience mild side effects such as nausea or stomach discomfort. Rarely, allergic reactions may occur. The sensory tests may cause mild, temporary discomfort but no pain. If any side effects occur, the study medication will be stopped and appropriate care will be provided. Is participation voluntary? Yes. Participants can withdraw from the study at any time without any impact on their regular dental or medical care. Where will the study take place? The study will be conducted at the Faculdade de Odontologia da Universidade de São Paulo (FOUSP) and the Fundação para o Desenvolvimento da Odontologia (FUNDECTO).

Conditions

Paresthesia and Hypoesthesia

Keywords

paresthesia; third molar; surgery, oral

Outcome Measures

Primary Outcomes (1)

• Change in Static Two-Point Discrimination (2PD) Threshold

  Mean change in the smallest detectable distance (in millimeters) between two points applied to the skin of the affected lower lip or chin area, measured from baseline (T0) to 8 weeks (T5). A reduction in 2PD threshold indicates improved tactile discrimination and sensory recovery following inferior alveolar nerve injury. Testing is performed using a calibrated two-point discriminator (disk-criminator) applied along the longitudinal axis of the lip. Three measurements are taken, and the median value is recorded. Normal threshold for the lower lip is 2-5 mm. Higher thresholds (e.g., \>10 mm) indicate greater sensory impairment.

  Baseline (Day 0) to 8 weeks (Day 56 / T5)

Study Arms (2)

1

EXPERIMENTAL

Vitamin B Complex

Drug: Vitamin B Complex

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Vitamin B Complex DRUG

One oral capsule taken daily for 56 days (8 weeks). Each capsule contains a fixed-dose combination of eight B vitamins: thiamine (B1) 10 mg, riboflavin 10 mcg, niacin (91% niacinamide/9% niacin) 100 mg, pyridoxine (B6) 10 mg, folate (folic acid) 400 mcg, cyanocobalamin (B12) 12 mcg, biotin 45 mcg, and pantothenic acid 20 mg. This specific formulation targets multiple neurotrophic pathways-myelin synthesis (B12), axonal regeneration (B6), and neuronal energy metabolism (B1)-at doses within the therapeutic range for peripheral neuropathy. Capsules are opaque, size #0, white, and packaged in a white bottle labeled only with participant ID and dosing instructions.

1

Placebo DRUG

One oral capsule taken daily for 56 days (8 weeks). Each capsule contains only the inert pharmaceutical vehicle (microcrystalline cellulose) without any active B vitamins. Placebo capsules are identical in appearance to the active intervention: same size #0, opaque white shell, same weight, and same packaging in a white bottle labeled only with participant ID and dosing instructions. This ensures successful blinding of participants, outcome assessors, and the principal investigator. The placebo controls for the psychological expectation of improvement (placebo effect) and allows isolation of the true physiological effect of vitamin B complex on nerve regeneration.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of mandibular neurossensorial disturbances.
• Must be able to swallow tablets

You may not qualify if:

• \- Any known allergy to complex B supplementation or its components.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (3)

• Barroso AB, Lima V, Guzzo GC, Moraes RA, Vasconcellos MC, Bezerra MM, Viana FA, Bezerra RC, Santana GS, Frota-Bezerra FA, Moraes MO, Moraes ME. Efficacy and safety of combined piroxicam, dexamethasone, orphenadrine, and cyanocobalamin treatment in mandibular molar surgery. Braz J Med Biol Res. 2006 Sep;39(9):1241-7. doi: 10.1590/s0100-879x2006000900012.

  PMID: 16981050 RESULT

• Ang CD, Alviar MJ, Dans AL, Bautista-Velez GG, Villaruz-Sulit MV, Tan JJ, Co HU, Bautista MR, Roxas AA. Vitamin B for treating peripheral neuropathy. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD004573. doi: 10.1002/14651858.CD004573.pub3.

  PMID: 18646107 RESULT

• Ghasemi S, Babaloo A, Sadighi M, Torab Z, Mohammadi H, Khodadust E. Effect of vitamin B complex administration on pain and sensory problems related to inferior alveolar nerve damage following mandibular implant placement surgery. J Adv Periodontol Implant Dent. 2022 May 30;14(1):13-19. doi: 10.34172/japid.2022.007. eCollection 2022.

  PMID: 35919449 RESULT

MeSH Terms

Conditions

Paresthesia; Hypesthesia

Interventions

Vitamin B Complex

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Ricardo Grillo Assistant Professor, PhD

CONTACT

+5511997117767; grillo@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. The following parties are masked to group assignment (vitamin B complex vs. placebo): Participants: Unaware of which capsule they receive (active or placebo). Outcome Assessors: Clinicians performing all sensory tests (monofilaments, two-point discrimination, pinprick, thermal) are blinded. Principal Investigator (during data collection): Unaware of treatment allocation while participants are actively enrolled and undergoing follow-up. Data Analyst / Statistician: Remains blinded until database lock and final analysis. A blinded sample size re-estimation will be performed after the pilot phase, during which the statistician will only observe pooled variance without group identifiers. Study Coordinator (during visits): May interact with participants but does not have access to the randomization list or medication kit contents. Only one individual (Pharmacy Custodian) is unblinded. This person: Generates the randomization sequence. Prepares and label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a parallel-group, superiority trial with a 1:1 allocation ratio. Participants are randomly assigned to either the vitamin B complex arm or the placebo arm and remain in that single arm for the entire 8-week study duration. No crossover between arms occurs. The study employs a superiority framework to test whether vitamin B complex yields significantly greater sensory recovery compared to placebo. A parallel-group design was chosen over a crossover design because sensory recovery from nerve injury may not return to baseline after washout, making crossover inappropriate. Additionally, the natural history of inferior alveolar nerve paresthesia includes spontaneous improvement over time, which would confound interpretation in a crossover design. The parallel design eliminates carryover effects and simplifies interpretation of treatment effects, while maintaining adequate statistical power through the planned sample size of 50 participants.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): June 10, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05