CompletedNot Applicable

Periapical Bleeding Versus PRF Techniques in Regenerative Endodontic Therapy: A Randomized Controlled Trial

Turkey (Türkiye)48 participantsStarted 2024-02-03

Plain-language summary

This study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative endodontic treatment is a novel approach that enables the tooth to repair itself. This treatment method involves inducing bleeding in the root area or applying special blood derivatives (PRF types) to accumulate healing-supporting cells and growth factors. The aim of the study is to compare the effects of different biological treatment methods on the healing process, postoperative pain, and tooth discoloration. The results may help develop more effective and aesthetically successful treatment options in the future.

Who can participate

Age range

14 Years – 65 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: * Single-rooted teeth with mature teeth with necrotic pulp requiring endodontic treatment, and a periapical lesion (Periapical Index Score (PAI) ≥3). * Individuals without systemic diseases, not using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications, and not pregnant. * Patients without acute pain. * Patients without extraoral swelling, sinus tract, or acute apical abscess. * Individuals willing to participate and able to attend follow-up sessions regularly. Exclusion Criteria: * Teeth with internal or external root resorption or vertical root fractures. * Immature teeth. * Individuals outside the age range of 14-65 years. * Patients with complicated systemic diseases or those using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications. * Patients with acute pain, those who have taken analgesic medication in the last 24 hours, or those who have used antibiotics within two weeks before treatment. * Patients who are unlikely to attend follow-up sessions.

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

Radiographic Assessment of Lesion Healing at 6 Months

Timeframe: Baseline and 6 months

Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment

Timeframe: Post-Treatment at 24 Hours, 72 Hours, and 1 Week

Assessment of Tooth Discoloration at 6 Months

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT06886438

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-10

View on ClinicalTrials.gov More Necrotic Pulp trials