Trial | NCT03403985  Report issue

Title

Long-term Evaluation of Direct Pulp Capping
Long-term Evaluation of Direct Pulp Capping Using Either Mineral Trioxid Aggregate or Calcium Hydroxide in Permanent Mature Teeth: A Randomized Controlled Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.
Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.

The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.

A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.
Study Started
Jun 01
2017
Primary Completion
Jun 28
2017
Study Completion
Jun 30
2022
Anticipated
Last Update
Sep 25
2019

Drug Calcium Hydroxide (Ca(OH)2)

Ca(OH)2 will be used in this group

  • Other names: Ca(OH)2

Drug Mineral Trioxide Aggregate

MTA will be used in this group

  • Other names: MTA

calcium hydroxide direct pulp capping Experimental

calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group

MTA direct pulp capping Experimental

Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group

Criteria 

Inclusion Criteria:

carious teeth that had no previous root canal treatment
Pulpal diagnosis of normal or reversible pulpitis

Exclusion Criteria:

History of irreversible pulpal pain
Immature teeth
Non restorable teeth
Teeth with active periodontal disease
History of any systemic disease
Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
No Results Posted