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Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

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ClinicalTrials.gov Identifier: NCT04710160
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Nashwa Ossama Ahmed Elshaer, Cairo University

Study Description
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Brief Summary:
The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Condition or disease Intervention/treatment Phase
Clinical Evaluation Including Pain and Swelling Drug: Novel fast-setting calcium silicate cement (Protooth) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Minerals

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Novel fast setting calcium silicate ( Protooth)
In the form of powder and liquid to be mixed together to form paste.
 Drug: Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.
Other Name: mineral trioxide aggregate (MTA )
Experimental: MTA
In form of powder to be mixed with saline to form paste.
 Drug: Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.
Other Name: mineral trioxide aggregate (MTA )


Outcome Measures
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Primary Outcome Measures :
  1. Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS [ Time Frame: 12 months ]

    Post-operative pain following pulpotomy treatment will be measured.

    A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:

    0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.



Secondary Outcome Measures :
  1. Radiographic evaluation following the Pulpotomy treatment will be measured [ Time Frame: 12 months ]
    Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
  • No allergic reactions recorded in patient history
  • Having primary molar teeth in one jaw, having deep caries and vital pulp.
  • No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule

  • Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

    • Radiographic criteria:
  • No sign of radiolucency in periapical or furcation area
  • No widening of PDL space or loss of lamina dura continuity
  • No evidence of internal/external pathologic root resorption

Exclusion Criteria:

  • Lack of informed consent by the child patient's parent
  • Lack of informed consent by the child patient's parent
  • Unable to attend follow-up visits.
  • Refusal of participation.
Contacts and Locations
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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): NCT04710160


Contacts
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Contact: Adel Elbardissy, professor 01271289999 adelbardissy@dentistry.cu.edu.eg
Contact: Passant Nagy, Doctorat 0128557107 passant.nagi@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of Dentsitry , Cairo University
Cairo, El Manial, Egypt, 11553
Contact: Adel Elbardissy, Professor    01271289999    adelbardissy@dentistry.cu.edu.eg   
Contact: Passant Nagy, Doctorat    01280557107    passant.nagi@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Nashwa Ossama Ahmed Elshaer, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04710160    
Other Study ID Numbers: Pedo193
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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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 Nashwa Ossama Ahmed Elshaer, Cairo University:
Pulpotomy , Primary molars , Protooth , MTA
Additional relevant MeSH terms:
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Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs