Color Stability of NeoMTA Pulpotomized Primary Teeth (NCT03254290) | Clinical Trial Compass
UnknownEarly Phase 1
Color Stability of NeoMTA Pulpotomized Primary Teeth
15 participantsStarted 2017-10-01
Plain-language summary
This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15 teeth will be treated for each treatment group. The specific treated tooth will be randomized as to which side will receive the MTA or formocresol using sealed, opaque envelopes. Approximately 15 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis.
Who can participate
Age range
30 Months – 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:
Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months
Exclusion Criteria:
Teeth with a history of spontaneous pain. Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space
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
1
Color stability
Timeframe: 3 month recall
Trial details
NCT IDNCT03254290
SponsorTexas A & M University Baylor College Of Dentistry