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Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA-Anglus
TheraCal
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring pulpotomy, deep caries, permanent molars, MTA

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Restorable permanent molars with deep caries and pain could be relieved with analgesics

Exclusion Criteria:

  • criteria of exclusion of teeth were:

    • pathological mobility, swelling or tenderness to percussion/palpation;
    • pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
    • at the operative procedure, hemorrhage control is unachievable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TheraCal vital pulp therapy

    MTA vital pulp therapy

    Arm Description

    Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.

    Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.

    Outcomes

    Primary Outcome Measures

    Survival rate
    absence of any complication or complementary treatment (absence of spontaneous pain or swelling)

    Secondary Outcome Measures

    periapical radiolucency
    presence or absence of periapical radiolucency radiographically
    internal/ external root resorption
    presence or absence of internal/ external root resorption radiographically
    Root maturation
    Root maturation assessment radiographically

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    July 21, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03119779
    Brief Title
    Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
    Official Title
    The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    April 30, 2017 (Actual)
    Study Completion Date
    April 30, 2017 (Actual)

    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
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient. Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.
    Detailed Description
    Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental
    Keywords
    pulpotomy, deep caries, permanent molars, MTA

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    TheraCal vital pulp therapy
    Arm Type
    Experimental
    Arm Description
    Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
    Arm Title
    MTA vital pulp therapy
    Arm Type
    Active Comparator
    Arm Description
    Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.
    Intervention Type
    Drug
    Intervention Name(s)
    MTA-Anglus
    Other Intervention Name(s)
    MTA-Anglus vital pulp therapy
    Intervention Description
    MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.
    Intervention Type
    Drug
    Intervention Name(s)
    TheraCal
    Other Intervention Name(s)
    TheraCal vital pulp therapy
    Intervention Description
    TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
    Primary Outcome Measure Information:
    Title
    Survival rate
    Description
    absence of any complication or complementary treatment (absence of spontaneous pain or swelling)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    periapical radiolucency
    Description
    presence or absence of periapical radiolucency radiographically
    Time Frame
    12 months
    Title
    internal/ external root resorption
    Description
    presence or absence of internal/ external root resorption radiographically
    Time Frame
    12 months
    Title
    Root maturation
    Description
    Root maturation assessment radiographically
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Time lapse till final restoration performed
    Description
    measured using stop watch to assess which material needs less chair side time to be finished.
    Time Frame
    from 5 till 20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Restorable permanent molars with deep caries and pain could be relieved with analgesics Exclusion Criteria: criteria of exclusion of teeth were: pathological mobility, swelling or tenderness to percussion/palpation; pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space; at the operative procedure, hemorrhage control is unachievable
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Passant Nagi, MSc
    Organizational Affiliation
    Assisternt lecturer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

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