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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Pulp Capping; Dental Caries Extending to Pulp
• Intervention / Treatment: Drug: Calcium Hydroxide (Ca(OH)2); Drug: Mineral Trioxide Aggregate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Dental health center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Lama Awawdeh, PhD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 28, 2017
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: JordanUST2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No