CompletedPhase 2/3

Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Chile169 participantsStarted 2014-04

Plain-language summary

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Who can participate

Age range

7 Years – 16 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: * Systemically healthy patients * Patients with at least one full or partial tooth root development * Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis * Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration * Teeth that have pulp exposure not exceeding 1 mm in size. Exclusion Criteria: * Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic * Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

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

Parameters Evaluated After Treatment

Timeframe: 3 months, 6 moths and 12 months

Trial details

NCT IDNCT02492841

SponsorUniversidad de los Andes, Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2017-05-01

View on ClinicalTrials.gov More Caries trials