Indirect and Direct Pulp Therapy in Primary Second Molars (NCT07382115) | Clinical Trial Compass
CompletedNot Applicable
Indirect and Direct Pulp Therapy in Primary Second Molars
Turkey (Türkiye)45 participantsStarted 2019-04-30
Plain-language summary
The purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Children with deep dentin caries in primary molars were randomly assigned to receive either IPT or DPC. Clinical and radiographic evaluations were performed at 6 and 12 months to assess treatment success. The findings of this study aim to provide evidence-based guidance for the management of deep dentin caries in primary teeth.
Who can participate
Age range
7 Years – 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:
* Systemically healthy children aged 7 to 9 years
* Primary second molars with deep dentin caries indicated for vital pulp therapy
* Absence of clinical signs or symptoms of irreversible pulpitis
* No spontaneous or prolonged pain
* Teeth with no tenderness to percussion or palpation
* No pathological mobility, swelling, fistula, or abscess
* Radiographic findings showing intact lamina dura and normal periodontal ligament space
* Absence of periapical or furcation radiolucency
* No evidence of pathological internal or external root resorption
* Teeth considered restorable
* Written informed consent obtained from parents
Exclusion Criteria:
* Children with systemic diseases or medical conditions affecting healing
* Teeth with signs or symptoms of irreversible pulpitis
* Presence of spontaneous pain, night pain, or prolonged pain
* Teeth with periapical or furcation radiolucency
* Teeth with pathological internal or external root resorption
* Presence of pulpal calcifications or pulp stones
* Non-restorable teeth
* Lack of parental consent
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
Clinical success of indirect pulp treatment and direct pulp capping
Timeframe: 12 months
2
Radiographic success of indirect pulp treatment and direct pulp capping