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Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.

Primary Purpose

Reversible Pulpitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA
TheraCal PT
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reversible Pulpitis

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 4 to 7 years , in good general health and mentally free.
  • The parents provided written informed consent.
  • Cariously exposed primary molars with reversible pulpitis.
  • Teeth should be vital.
  • Restorable teeth.
  • Hemostasis achieved after complete pulpotomy

Exclusion Criteria:

  • With systemic disease.
  • Physical or mental disability.
  • Unable to attend follow-up visits.
  • Refusal of participation.
  • Previously accessed teeth.
  • History of spontaneous or prolonged pain.
  • Swelling, tenderness to percussion or palpation, or pathological mobility.
  • Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
  • Haemorrhage control is unachievable after pulpotomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Mineral trioxide aggregate (MTA)

    TheraCal PT

    Arm Description

    Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)

    Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)

    Outcomes

    Primary Outcome Measures

    Survival rate (Absence of spontaneous pain)
    Binary outcome measured with direct questioning to the patient
    Survival rate (Absence of spontaneous pain)
    Binary outcome measured with direct questioning to the patient
    Survival rate (Absence of swelling)
    Binary outcome measured visually by intraoral/extraoral examination
    Survival rate (Absence of swelling)
    Binary outcome measured visually by intraoral/extraoral examination

    Secondary Outcome Measures

    Absence of periapical radiolucency or absence of internal/external root resorption
    Binary outcome detected with periapical x-ray by parallel technique using XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
    Time lapse till final restoration performed.
    Continuous outcome measured with a Stopwatch in minutes.

    Full Information

    First Posted
    October 22, 2020
    Last Updated
    March 2, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04617600
    Brief Title
    Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
    Official Title
    Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars: A Randomized Controlled Pilot Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    November 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
    Detailed Description
    for both interventions , Informed consent from participating parents. Baseline records photographs, percussion test, periapical radiograph and personal data collection. Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of dressing material that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity). Diagnostic chart with personal, medical and dental history will be filled. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnosis is established after clinical examination). Preoperative and Postoperative photographs will be taken. The radiographic examination will be performed by taking periapical x-ray using (parallel technique) through machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using x-ray holding device. Preoperative and postoperative radiograph will be taken by parallel technique using extension cone paralleling (XCP) film holder. Administration of inferior alveolar nerve block (Septodont, Scandonest® 2% L Mepivacaine hydrochloride (HCl). 2% and Levonordefrin 1:20,000 Injection, U.S.P.) at the side of the affected tooth. Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet. Children will then be allocated into either one of the groups alternatively depending on the pulpotomy medicament used as follows: Group I (Experimental group) TheraCal PT pulpotomy. Group II (Control group) MTA pulpotomy. Group I (Experimental group) TheraCal PT: After complete hemostasis, TheraCal PT (BISCO Dental Products, Schamberg illinois (IL), U.S.A.) will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement. Tooth will then be restored with stainless steel crown. Group II (Control group) MTA pulpotomy: After complete hemostasis, MTA+ Curamed (ul. Kwiatkowskiego 1, 37-450 stylosa Wola, Polka) will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement. Tooth will then be restored with stainless steel crown.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reversible Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mineral trioxide aggregate (MTA)
    Arm Type
    Active Comparator
    Arm Description
    Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)
    Arm Title
    TheraCal PT
    Arm Type
    Experimental
    Arm Description
    Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)
    Intervention Type
    Drug
    Intervention Name(s)
    MTA
    Other Intervention Name(s)
    Mineral trioxide aggregate
    Intervention Description
    Survival rate using MTA in cariously exposed vital primary molars
    Intervention Type
    Drug
    Intervention Name(s)
    TheraCal PT
    Other Intervention Name(s)
    TheraCal PT®
    Intervention Description
    Survival rate using TheraCal PT in cariously exposed vital primary molars
    Primary Outcome Measure Information:
    Title
    Survival rate (Absence of spontaneous pain)
    Description
    Binary outcome measured with direct questioning to the patient
    Time Frame
    "3 months"
    Title
    Survival rate (Absence of spontaneous pain)
    Description
    Binary outcome measured with direct questioning to the patient
    Time Frame
    "6 months"
    Title
    Survival rate (Absence of swelling)
    Description
    Binary outcome measured visually by intraoral/extraoral examination
    Time Frame
    "3 months"
    Title
    Survival rate (Absence of swelling)
    Description
    Binary outcome measured visually by intraoral/extraoral examination
    Time Frame
    "6 months"
    Secondary Outcome Measure Information:
    Title
    Absence of periapical radiolucency or absence of internal/external root resorption
    Description
    Binary outcome detected with periapical x-ray by parallel technique using XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
    Time Frame
    "6 months"
    Title
    Time lapse till final restoration performed.
    Description
    Continuous outcome measured with a Stopwatch in minutes.
    Time Frame
    "During procedure".

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 4 to 7 years , in good general health and mentally free. The parents provided written informed consent. Cariously exposed primary molars with reversible pulpitis. Teeth should be vital. Restorable teeth. Hemostasis achieved after complete pulpotomy Exclusion Criteria: With systemic disease. Physical or mental disability. Unable to attend follow-up visits. Refusal of participation. Previously accessed teeth. History of spontaneous or prolonged pain. Swelling, tenderness to percussion or palpation, or pathological mobility. Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency. Haemorrhage control is unachievable after pulpotomy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem Mohamed Gaber, B.Sc
    Phone
    01115578688
    Ext
    0020
    Email
    reem.gaber@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Passant Nagi, PHD
    Phone
    01280557107
    Ext
    0020
    Email
    Passant.Nagi@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.

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