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Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure (PULPOTOMY)

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: NCT03522051
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Jordan University of Science and Technology

Brief Summary:
Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.

Condition or disease Intervention/treatment Phase
Pulpotomy Other: calcium silicate based material, Not Applicable

Detailed Description:

Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.

The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.

Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with carious teeth
female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.
Other: calcium silicate based material,
Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation
Other Name: Neo MTA plus, Avalon Biomed




Primary Outcome Measures :
  1. Change in pain symptoms [ Time Frame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years. ]
    The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.


Secondary Outcome Measures :
  1. Periapical normalcy at follow up radiographs . [ Time Frame: 6months , 1 year, 2, 3,4,5 years ]

    Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years.

    no emerging pathosis should be evident in the roots or surrounding bone.


  2. The tooth and restoration should be present in the mouth [ Time Frame: 3, 6 months, 1 year, 2, 3,4,5 years ]
    The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times



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Ages Eligible for Study:   7 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Permanent teeth with mature or immature apices
  • Have no significant medical problems
  • The tooth should give positive response to cold test and electric pulp test (EPT)
  • Probing pocket depth and mobility within normal limits
  • No Signs of pulp necrosis including sinus tract or swelling
  • Radiographically ; caries either exposing the pulps or reaching more than 2\3 the distance from the dentino-enamel junction (DEJ) to the pulp
  • The tooth can be restored via direct restoration

Exclusion Criteria:

  • Medically compromised patients
  • Negative response to cold test
  • Mobility
  • Sinus tract
  • Swelling
  • Non restorable teeth or badly broken teeth

Information from the National Library of Medicine

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): NCT03522051


Locations
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Jordan
Jordan University of science and technology
Irbid, Jordan, 22110
Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
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Study Director: Nessrin A Taha, PhD Jordan University of Science and Technology
  Study Documents (Full-Text)

Documents provided by Jordan University of Science and Technology:
Study Protocol  [PDF] October 10, 2016

Publications:
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Responsible Party: Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03522051    
Other Study ID Numbers: JUST14-4-2018
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Baseline demographic data and follow-up results may be shared after manuscript acceptance by international journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordan University of Science and Technology:
teeth
pulpitis
deep caries
pulpotomy
Mineral Trioxide Aggregate (MTA)
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs