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Clinical and Radiographic Assessments of Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as Pulpotomy Biomaterials in Immature Mandibular First Permanent Molars

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ClinicalTrials.gov Identifier: NCT03166748
Recruitment Status : Unknown
Verified May 2017 by Mohammed Ibrahim Ahmed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Ibrahim Ahmed, Cairo University

Brief Summary:
The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital immature permanent lower first molar and this will help to clinically evaluate the use of alternative capping material in vital pulpotomy in young permanent teeth with pathologic pulpal injuries emphasis is set on avoiding total pupectomy and maintaining radicular pulp vitality and function and therefore maintain the tooth in a viable condition that help root completion.

Condition or disease Intervention/treatment Phase
Pulpotomy of Immature Lower First Molar(Apexegenesis) Combination Product: Potassium Nitrate in Polycarboxylate cement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Compare the Clinical/Radiographic Outcomes of Potassium Nitrate in Polycarboxylate Cement and MTA as Pulpotomy Biomaterials Used for Asymptomatic Vital Immature Permanent Lower First Molars
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Potassium

Arm Intervention/treatment
Active Comparator: MTA pulpotomy
mineral trioxide aggregates (MTA) is accepted as an optimum material for use in vital pulp therapy of permanent teeth
Combination Product: Potassium Nitrate in Polycarboxylate cement

The application of polycarboxylate cement containing 5% KNO3 for direct capping of traumatically exposed pulp in animal models did not result in any degenerative changes in dental pulp, thought creating optimal conditions for preservation of pulp vitality and root completion.

Polycarboxylate cement has very thin film thickness and bonds firmly to the tooth structure, is capable of withstanding the overlying pressure during restoration procedures. The good adhesive properties of polycarboxylate cement containing 5% KNO3 guaranteed the closure of cavity, good and lasting protection of traumatically exposed dental pulp and the formation of alkaline environment possessing a strong antiacidic, anti-inflammatory and antibacterial effect of this pulp capping material, creating optimal conditions for expression of its natural reparative potential. The increased release of potassium nitrate from polycarboxylate cement by time, might be the cause of decreasing the inflammatory intensity


Experimental: Potassium Nitrate in Polycarboxylate cement
Potassium nitrate (KNO3) is a superior desensitizer for hypersensitive teeth. Used with polycarboxylate cement, it serves as an effective liner for deep carious lesions. Also when placed under deep restorations with less than 1 mm of protective dentin remaining, it was effective in preserving pulpal vitality and it diminished the incidence and severity of post-restoration pain. As temporary cement (Kno3/zinc oxide eugenol [ZOE]) It reduced pain following full crown preparation.
Combination Product: Potassium Nitrate in Polycarboxylate cement

The application of polycarboxylate cement containing 5% KNO3 for direct capping of traumatically exposed pulp in animal models did not result in any degenerative changes in dental pulp, thought creating optimal conditions for preservation of pulp vitality and root completion.

Polycarboxylate cement has very thin film thickness and bonds firmly to the tooth structure, is capable of withstanding the overlying pressure during restoration procedures. The good adhesive properties of polycarboxylate cement containing 5% KNO3 guaranteed the closure of cavity, good and lasting protection of traumatically exposed dental pulp and the formation of alkaline environment possessing a strong antiacidic, anti-inflammatory and antibacterial effect of this pulp capping material, creating optimal conditions for expression of its natural reparative potential. The increased release of potassium nitrate from polycarboxylate cement by time, might be the cause of decreasing the inflammatory intensity





Primary Outcome Measures :
  1. clinical signs and symptoms assessment [ Time Frame: 1 week, 3 month, 6 and 12 months after treatment ]

    patient will take a chart to make yes or no in this cases spontaneous pain,

    sensitivity to percussion ⁄ palpation

    excessive mobility

    soft tissue swelling

    sinus tract



Secondary Outcome Measures :
  1. radiographic assessment of root completion [ Time Frame: post operative,3 month, 6 and 12 months after treatment) ]
    radiographic assessment of root completion using radiometric analysis will be used to evaluate change in root length and dentin wall thickness at the end of study by aids of image j soft ware



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Egyptian children from 6-9 years
  • Pathological caries or traumatic exposure
  • lower immature first molar
  • Asymptomatic irreversible pulpitis (no clinical symptoms of tooth or periapical pain in case of deep dental caries with pulp exposure during caries excavation

Exclusion Criteria:

  • -Case of necrotic pulp tissue
  • Pulp polyp
  • Tooth tender to percussion
  • Clinical progression into abscess formation.
  • Medically compromised patient
  • Tooth with abnormal anatomy
  • Furcation involvement or canal calcification
  • Excessive bleeding from root canal
  • Tooth is unrestorable

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): NCT03166748


Contacts
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Contact: mohammed ibrahim ahmed, master degree candidate +201006619722 mohammed-ahmed@dentistry.cu.edu.eg
Contact: . Hamdy Adly, Professor of Endodontics

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ghada El Hilaly eid, Professor of Endodontics operator

Publications:
Borissov, S. Tsanova, D. Sivrev. Tissue Response of Dental Pulp in Dogs Following Direct Capping With Potassium Nitrate in Polycarboxylate Cement. Bulgarian Journal of Veterinary Medicine. 2007;10:35−43
Kamel M S, Ahmed G M, Yousef H A, AL-Mogy S A. An Improved Technique OF pulp capping by using the Metal Cap with Different Types of Materials. Cairo dental journal .2014;30:1955-1963.

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Responsible Party: Mohammed Ibrahim Ahmed, master candidate at endodontic department faculty of dentistry cu, Cairo University
ClinicalTrials.gov Identifier: NCT03166748     History of Changes
Other Study ID Numbers: CBC-CU-2017-0518
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Mohammed Ibrahim Ahmed, Cairo University:
Incomplete lower first molar
Immature permanent molar
Potassium nitrate in polycarboxylate
Mineral trioxide aggregate .Mineral trioxid