Phase 3
Completed N=169
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
Caries · Dental Pulp Exposure
Source: ClinicalTrials.gov NCT02492841 ↗
Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Parameters Evaluated After Treatment — 19; 19; 25; 3 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parameters Evaluated After Treatment |
19; 19; 25; 3; 3; 0 | — |
| SECONDARY Number of Participants With Adverse Effects |
0; 0; 0 | — |
Eligibility Criteria
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 .
Data sourced from ClinicalTrials.gov (NCT02492841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.