Not Yet RecruitingNot Applicable

The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

30 participantsStarted 2023-09-01

Plain-language summary

Dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. However, regeneration of functional dental pulp has proved difficult. Therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * Patients aged 18 to 45 years * Patients with pulp necrosis of a single canal permanent tooth due to trauma or caries * Patients who have signed informed consent Exclusion Criteria: * Patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc * Patients with calcification of the apical foramen at the root of the tooth * History of hereditary disorders of abnormal tooth development * Dental occlusal trauma, bruxism, malocclusion * Bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.) * Presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity) * Malnutrition (serum albumin concentration\<2 g/dl) * Patients with history of other systemic, communicable or hereditary diseases have been diagnosed * Pregnant, nursing, planning to become pregnant * The investigators determined that the patient was not suitable for the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of pulp vitality

Timeframe: 1、3、6、12、18、24 months

Trial details

NCT IDNCT05728346

SponsorFifth Affiliated Hospital of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Pulp Necroses trials