Vitamin B Complex for Inferior Alveolar Nerve Paresthesia Recovery

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

Interventions

DRUG

Vitamin B Complex

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-10

Primary Completion

2026-11-10

Completion

2028-06-10