CompletedPhase 3

Assessment of the Number of Missing Tooth Surfaces and the Molecular Findings on the Outcomes of Vital Pulp Therapy Using Two Calcium Silicate Materials

Egypt60 participantsStarted 2022-09-21

Plain-language summary

The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to: A. Number of tooth surfaces defects: * Class I cavity defect. * Class II cavity defect. B. Using two types of pulpotomy dressing materials: * MTA+ (Cerkamed, Stalowa, Poland). * Well-Root PT (Vericom, Gangwon-Do, Korea). And., To correlate this outcome to the quantification of two biomolecules: * Tumor necrosis factor-alpha (TNF-⍺). * Matrix metalloproteinases-9 (MMP-9). Based on the results of the present study, it was concluded that: 1. Full pulpotomy using calcium silicate cements (CSCs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis. 2. Class I and class II cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials. 3. Although MTA+ and Well-Root PT yielded similar outcomes for pulpotomy in terms of success rates. Well-root PT is easier to handle compared to MTA+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with MTA+. 4. Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome. 5. The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.

Who can participate

Age range

21 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: * Mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis. * Age range of 21-45 years old. * Males or females. * No disabilities. * Class I and/or class II cavity defects. * Teeth reveal positive response to cold tests. Exclusion Criteria: * Presence of open apices. * Non-restorable teeth. * Teeth in which the pulpal bleeding time is more than 10 minutes. * Presence of large carious lesions approaching the root. * Presence of calcification or resorption. * Periodontally affected teeth. * Patients who are taking antibiotics within one week before treatment. * Patients consumed taking analgesics within 24 hours before treatment. * Systemically compromised patients. * Pregnant females.

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

success/failure

Timeframe: Patients were scheduled for follow-up appointments (one week, 3, 6, and 12 months)

Pain assessment

Timeframe: every 24 hours in the evening for 7 days

Trial details

NCT IDNCT06787742

SponsorSuez Canal University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

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