Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT (NCT02702505) | Clinical Trial Compass
UnknownPhase 4
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
United States50 participantsStarted 2014-11
Plain-language summary
Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use in vital teeth has demonstrated significant color change post-treatment leaving it ineffective for esthetic use..
The new formulation will be tested to see if has the same effect.
Who can participate
Age range
2 Years – 8 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 8 years of age
* Patient must have two, contralateral primary molars that are matched for type of molar (first or second), size of carious lesion (same level of approximation of carious lesion to the pulp), and arch (maxillary or mandibular) 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 two years
* Each patient must have an updated medical history form in the dental record, be examined by the operator, and be classified as ASA I or II (in good general health)
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: 2 years
2
Internal resorption
Timeframe: 2 years
3
external resorption
Timeframe: 2 years
4
Bone loss
Timeframe: 2 years
5
Widening of periodontal ligament space
Timeframe: 2 years
Trial details
NCT IDNCT02702505
SponsorTexas A & M University Baylor College Of Dentistry