Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars (NCT06433297) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars
India106 participantsStarted 2024-05-23
Plain-language summary
Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Who can participate
Age range
18 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
. The patient should be ≥18 years of age.
. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)
. Tooth should give positive response to pulp sensibility testing.
. Clinical diagnosis of moderate pulpitis.
. Radiographic finding of periapical index (PAI) score ≤2.
. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
. Pulp exposure after complete caries excavation.
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 Rate
Timeframe: 12 months
2
Radiographic success
Timeframe: 12 months
Trial details
NCT IDNCT06433297
SponsorPostgraduate Institute of Dental Sciences Rohtak
. No pulp exposure after incomplete caries excavation
Exclusion criteria
. Teeth with immature roots.
. Pulp exposure after incomplete caries excavation.
. No pulp exposure after complete caries excavation.
. Bleeding could not be controlled in 5 minutes.
. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
. Internal/external resorption.
. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)