Pulp capping Direct pulp capping

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Long-term Evaluation of Direct Pulp Capping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03403985
Recruitment Status :
Active, not recruiting

First Posted : January 19, 2018
Last Update Posted : April 17, 2018

Sponsor:
Jordan University of Science and Technology
Information provided by (Responsible Party):
Jordan University of Science and Technology

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Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Pulp Capping
Dental Caries Extending to Pulp
Drug: Calcium Hydroxide (Ca(OH)2)
Drug: Mineral Trioxide Aggregate
Not Applicable

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.

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Study Type : Interventional
 (Clinical Trial)

Estimated
Enrollment :
80 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Intervention Model Description: Randomized Controlled Retrospective clinical trial
Masking: Single (Participant)
Masking Description: patients are not aware about type of capping material used
Primary Purpose: Treatment
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
Actual Study Start Date :June 1, 2007
Actual Primary Completion Date :June 2017
Estimated Study Completion Date :June 2022
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Calcium
Minerals
Drug Information available for:
Calcium Gluconate
Calcium hydroxide
U.S. FDA Resources

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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 Name: 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 Name: MTA

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Primary Outcome Measures :

  1. clinical vital pulp therapy success [ Time Frame: from date of randomization until failure reported for up to 100 months ]
    Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs

Secondary Outcome Measures :

  1. Radiographic success [ Time Frame: from date of randomization until failure reported for up to 100 months ]
    treatment could be further evaluated based on the absence of canal oblitration

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.


Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403985

Locations
Jordan
Dental health center
Irbid, Jordan
Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
Principal Investigator:Lama Awawdeh, PhDJordan University of Science and Technology
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Responsible Party:Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03403985    
History of Changes
Other Study ID Numbers: JordanUST2
First Posted:January 19, 2018
  
Key Record Dates
Last Update Posted:April 17, 2018
Last Verified:April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:Undecided

Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No

Additional relevant MeSH terms:

Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
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