Long-term Evaluation of Direct Pulp Capping

NCT ID: NCT03403985

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2022-06-30

Brief Summary

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

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.

Conditions

Dental Pulp Capping; Dental Caries Extending to Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

calcium hydroxide direct pulp capping

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

Group Type: EXPERIMENTAL

Calcium Hydroxide (Ca(OH)2)

Intervention Type: DRUG

Ca(OH)2 will be used in this group

MTA direct pulp capping

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

Group Type: EXPERIMENTAL

Mineral Trioxide Aggregate

Intervention Type: DRUG

MTA will be used in this group

Interventions

Calcium Hydroxide (Ca(OH)2)

Ca(OH)2 will be used in this group

Intervention Type: DRUG

Mineral Trioxide Aggregate

MTA will be used in this group

Intervention Type: DRUG

Other Intervention Names

Ca(OH)2; MTA

Eligibility Criteria

Inclusion Criteria

1. carious teeth that had no previous root canal treatment

2. Pulpal diagnosis of normal or reversible pulpitis

Exclusion Criteria

1. History of irreversible pulpal pain

2. Immature teeth

3. Non restorable teeth

4. Teeth with active periodontal disease

5. History of any systemic disease

6. Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lama Awawdeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Dental health center

Irbid, , Jordan

Countries

Jordan

Other Identifiers

JordanUST2

Identifier Type: -

Identifier Source: org_study_id