Evaluating pulp capping agents on human teeth
Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
PHASE4 · Maharishi Markendeswar University (Deemed to be University) · NCT06435065
This study is testing how well four different materials can protect the nerves in healthy teeth from young patients who need their teeth removed for braces.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | All |
| Sponsor | Maharishi Markendeswar University (Deemed to be University) (other) |
| Locations | 1 site (Ambāla, Haryana) |
| Trial ID | NCT06435065 on ClinicalTrials.gov |
What this trial studies
This study investigates the response of human pulp tissue after applying four different direct pulp capping agents on premolars scheduled for extraction due to orthodontic treatment. A total of 40 healthy premolars from patients aged 15-25 years will be selected, ensuring they show no signs of caries or pulpitis. The teeth will be randomly assigned to one of four groups, each receiving a different pulp capping agent: Biodentine, MTA, TheraCal LC, or Tristrontium aluminate. The procedure will involve controlled exposure of the pulp and subsequent application of the assigned agent, followed by restoration of the teeth.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 15-25 with caries-free premolars planned for extraction due to orthodontic reasons.
Not a fit: Patients with irreversible pulpitis, caries, or other dental pathologies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of reversible pulpitis and enhance dental treatment outcomes.
How similar studies have performed: Previous studies have shown promising results with similar pulp capping agents, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons. * Teeth that show no reaction to percussion. * Teeth with no previous restorations. * Teeth that show vitality, when checked with an electric pulp tester. * Teeth that show no signs of caries or periapical pathology when examined * radiographically. * Fully erupted teeth, that allowed proper application of rubber dam. EXCLUSION CRITERIA: * caries are present * Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain * or spontaneous pain. * Teeth that show sensitivity to hot and/or cold. * Radiographic examination reveals any signs of caries, periapical pathology, * internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction * and/or calcifications in the pulp chamber or canals. * Medically compromised patient. * Pregnant patient.
Where this trial is running
Ambāla, Haryana
- Swati — Ambāla, Haryana, India (RECRUITING)
Study contacts
- Study coordinator: swati chhabra, MDS
- Email: drswatichhabra@gmail.com
- Phone: 7015070095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Reversible Pulpitis, DIRCT PULP CAPPING, Biodentine, MTA, TheraCal LC, Tristrontium Aluminate