CompletedNot Applicable

Biodentine as an Apical Plug in Immature Permanent Molars

Syria24 participantsStarted 2020-01-01

Plain-language summary

Following the randomization procedure, patients will be divided into 2 groups (12 immature molars in each group): Group I will be treated with MTA as apical plug, whereas group II will be treated with Biodentine as apical plug. After working length determination, instrumentation and sterilizing root canals, apical plug will be done as following: Biodentine Group: Biodentine will be placed into the apical portion of canals. After 12 min the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown. MTA Group: MTA will be placed into the apical portion of canals, then a moist cotton pellet will be placed and the access cavity will be restored with temporary filling. Next day, temporary filling and the cotton pellet will be removed, then the coronal restoration will be performed as Biodentine group. Patients of both groups will be recalled for clinical and radiographical follow-up within 12 months after treatment.

Who can participate

Age range

8 Years – 9 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: * Cooperative children. * Healthy children without any systemic disease or compromised immune status. * Children with first immature mandibular molar with at least one canal sized #60 or more with an apical lesion. Exclusion Criteria: * Patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss). * Molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external). * Molars that had previous endodontic treatment.

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

Change in the apical lesion size

Timeframe: after 1,3,6 and 12 months of root canal obturation

Change in the clinical assessment of success

Timeframe: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation

Trial details

NCT IDNCT05719987

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-30

View on ClinicalTrials.gov More Periapical Periodontitis trials