Long-term Evaluation of Direct Pulp Capping

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dental Pulp Capping, Dental Caries Extending to Pulp

Intervention / Treatment
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* Drug: Calcium Hydroxide (Ca(OH)2)
* Drug: Mineral Trioxide Aggregate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Retrospective clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: calcium hydroxide direct pulp capping<br>calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group | Drug: Calcium Hydroxide (Ca(OH)2)<br>* Ca(OH)2 will be used in this group<br>* Other names: Ca(OH)2;|
| Experimental: MTA direct pulp capping<br>Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group | Drug: Mineral Trioxide Aggregate<br>* MTA will be used in this group<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical vital pulp therapy success | Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs | from date of randomization until failure reported for up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success | treatment could be further evaluated based on the absence of canal oblitration | from date of randomization until failure reported for up to 100 months |