Long-term Evaluation of Direct Pulp Capping

Dental Caries Extending to Pulp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03403985
• Other study ID #: JordanUST2
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 2022

Study information

• Verified date: September 2019
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2022
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Extending to Pulp
• Dental Pulp Capping

Intervention

Drug:
• Calcium Hydroxide (Ca(OH)2)
Ca(OH)2 will be used in this group
• Mineral Trioxide Aggregate
MTA will be used in this group

Locations

Country	Name	City	State
Jordan	Dental health center	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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