Investigating a new cement for treating deep tooth decay
A Clinical Investigation of the Effectiveness of a Calcium Silicate Cement Used in the Treatment of Deep Lesions
This study is testing a new type of cement to see if it works better than an older one for treating deep tooth decay in adults aged 18 to 45.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06256601 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the effectiveness of calcium silicate cement compared to calcium hydroxide in treating deep caries lesions over an 18-month period. Eighty patients aged 18-45 with at least one deep dentin caries will be recruited from the Restorative Dentistry Clinic at Hacettepe University. The study will involve careful removal of carious tissue and application of the respective materials to the pulpal floor, followed by sealing with resin-modified glass ionomer cement. Clinical and radiographic evaluations will be conducted to assess the performance of the materials used.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with at least one deep dentin caries (D3) and no history of spontaneous pain in the affected teeth.
Not a fit: Patients with poor oral hygiene, severe periodontal pathology, or those undergoing orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with deep caries, potentially improving dental health outcomes.
How similar studies have performed: Other studies have shown promising results with calcium silicate materials in dental applications, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The age of the patient should be ranged between 18-45. * The score of the caries lesion should be D3. * Absence of a history of spontaneous pain in the teeth to be included. * Absence of periapical pathology * No displacement or mobility of the teeth. * Caries should not have reached the pulp tissue, and there should be no root fractures. * Restorable by direct restoration and functional Exclusion Criteria: * Poor oral hygiene of the participant. * Parafunctional habits such as teeth clenching or grinding. * Caries extending to the underneath of gingival margin * Severe periodontal pathology * Previous restored teeth * Teeth undergoing orthodontic treatment
Where this trial is running
Ankara
- Hacettepe University — Ankara, Turkey (Recruiting)
Study contacts
- Principal investigator: Uzay Koç Vural, Assoc. Prof. — Hacettepe University
- Study coordinator: Betül Kesim
- Email: bethulkesim@gmail.com
- Phone: +009005445768716
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.