A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpo… (NCT05479877) | Clinical Trial Compass
UnknownEarly Phase 1
A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars
40 participantsStarted 2022-09
Plain-language summary
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized.
The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption.
Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing.
Enamel and dentin contain Collagen as one of the components in their organic ground matrix.
Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential.
The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles
Who can participate
Age range
4 Years – 7 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
. Aged 4 to 7, in good general health and medically free.
. Cooperative patients who will comply to follow ups.
. Parents provided with written informed consent. • Teeth:
. Bilaterally Carious vital primary molars with reversible pulpitis.
. Restorable teeth with no more than 1/3 of root resorption.
Exclusion criteria
. Children with medical, physical, or mental conditions.
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.