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SDF Modified Hall Technique Vs. Conventional Pulpotomy for Management of Carious Primary Molars

Primary Purpose

Deep Carious Lesions

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SDF modified Hall technique
Conventional pulpotomy and stainless steel crown
Sponsored by
Sondos Naserallah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Carious Lesions

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children: Age 4 to 7 years medically free.
  • Primary molars with deep caries.
  • Vital pulp with no clinical signs and symptoms of irreversible pulpitis such as spontaneous pain.
  • Absence of swelling or pus exudate or fistula.
  • Absence of abnormal teeth mobility
  • Absence of pain on percussion

Exclusion criteria:

  • Patients experience signs or symptoms of pulpal or periapical pathology.
  • Patients requiring special dental consideration.
  • Unmotivated uncooperative patients.
  • Patients can't attend follow up visits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SDF modified Hall technique

    Conventional pulpotomy and stainless steel crown

    Arm Description

    When Hall technique is used an accurate size of PMC is placed without local anesthesia, caries removal, or tooth preparation. SDF is applied directly to carious lesions to arrest caries, the technique is noninvasive and relatively painless that could be a good option for treating dental caries in children

    Amputation of the coronal pulp and treatment of the remaining vital radicular portion with a long term clinically successful medicament. Then using an accurate size of stainless steel crown.

    Outcomes

    Primary Outcome Measures

    Postoperative pain
    Any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R).The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

    Secondary Outcome Measures

    Radiographic success
    Obvious furcation or periapical radiolucency by radiographic examination , (Internal and external) resorption by radiographic examination.
    Chair side time
    Stop watch (min.s)
    Child cooperation
    Evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)

    Full Information

    First Posted
    December 22, 2021
    Last Updated
    March 7, 2022
    Sponsor
    Sondos Naserallah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05240365
    Brief Title
    SDF Modified Hall Technique Vs. Conventional Pulpotomy for Management of Carious Primary Molars
    Official Title
    SDF Modified Hall Technique Versus Conventional Pulpotomy for Management of Carious Primary Molars: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sondos Naserallah

    4. Oversight

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

    5. Study Description

    Brief Summary
    Dental caries in primary teeth is considered the most common oral disease of childhood and it has been investigated in many places throughout the world. In most developed countries, the prevalence of early childhood caries (ECC) ranges between 1% and 12%. In less developed countries, however, the prevalence is much higher, exceeding 70%. Pulpotomy is a clinical procedure usually performed in primary molars with extensive caries, which implies removal of the coronal pulp and preservation of the radicular pulp. It is based on the ability of the remaining pulp tissue to heal after the affected or infected coronal pulp has been surgically removed. Pulpotomy is a technique that is highly dependent on a number of factors, including diagnosis accuracy, caries excavation method, pulp dressing material, final restoration quality and operator experience. Silver diamine fluoride (SDF) has recently become a non-invasive treatment option, it is fluid-form material used in prevention and treatment of teeth cavities (or caries). SDF has been demonstrated to be useful in arresting caries development after a cavity has formed. In hundreds of studies, the only common side effect of SDF has been black staining surrounding the area. SDF has the ability to stain anything it comes into contact with, including clothing and oral tissues. Hall technique is a method for management primary molar decay that involves the use of preformed metal crowns (PMCs) to seal decay. This technique may be able to stop or at least reduce caries progression in primary teeth. The process of fitting the crown is quick and non-invasive.
    Detailed Description
    Dental caries is the most common childhood disease and the most common health issue worldwide, despite a half-century of concerted clinical and public health efforts to eliminate it.Untreated caries causes health issues such as pain, poor quality of life, psychosocial suffering, as well as societal burdens such as reduced productivity at work and school. In order to reduce disease incidence and burden, meet population-level oral health goals, and address patient concerns, oral health education, home hygiene, avoidance of fermentable carbohydrates, consumption of fluoridated water, and access to and utilization of routine dental screenings, examinations, and care are all critical. Caries prevention and treatment strategies that are safe, easy, effective, low-cost, minimally invasive, and amenable to a variety of community settings are desired by dental public health and oral health stakeholders. One of the traditional methods of managing carious primary molars in children is conventional pulpotomy with stainless steel crowns (SSCs). Recently, other treatments are being used as silver diamine fluoride (SDF) and the Hall technique. Primary teeth pulpotomy is defined as amputation of the coronal pulp and treatment of the remaining vital radicular portion with a long term clinically successful medicament. An ideal medicament used for pulpotomy should have a bactericidal effect, enhance healing of the radicular pulp tissue and biocompatible then using an accurate size of stainless steel crown. Hall technique is one of the most common methods for sealing caries in primary molars nowadays. Dr. Norna Hall, a general dentist from Scotland, originally described Hall technique using preformed metal crowns (PMCs) in the literature in 2006. It has very straightforward biological principles. It can protect the primary tooth till shedding and arrest caries. The superficial plaque layer, which is the most essential element in the biofilm for caries growth, is left and sealed together with the carious lesion when using Hall technique. As a result, the plaque biofilm flora will be changed to be less cariogenic that may arrest or reduce the progression of caries in primary teeth. SDF has been proven to be effective in caries arrest. It's used to manage early childhood caries. Silver and fluoride ions combine to form SDF, a colorless ammonia solution. The fluoride in SDF has a long history of exaggerating enamel and dentine remineralization, while silver has been shown to have potent antimicrobial properties.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Carious Lesions

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SDF modified Hall technique
    Arm Type
    Experimental
    Arm Description
    When Hall technique is used an accurate size of PMC is placed without local anesthesia, caries removal, or tooth preparation. SDF is applied directly to carious lesions to arrest caries, the technique is noninvasive and relatively painless that could be a good option for treating dental caries in children
    Arm Title
    Conventional pulpotomy and stainless steel crown
    Arm Type
    Active Comparator
    Arm Description
    Amputation of the coronal pulp and treatment of the remaining vital radicular portion with a long term clinically successful medicament. Then using an accurate size of stainless steel crown.
    Intervention Type
    Device
    Intervention Name(s)
    SDF modified Hall technique
    Intervention Description
    Preparation for Hall technique and selection of the crown. Clinical application of SDF. Cementation of the selected crown.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional pulpotomy and stainless steel crown
    Intervention Description
    Teeth will be anesthetized . Rubber dam will be used and high suction in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. pulpal exposure will be occurred then the roof of pulp chamber will be removed by low speed round bur. Hemostasis will be obtained by applying pressure with moist cotton pellet with saline. Teeth will be treated by using sterile cotton pellet with formcresol for three to five min then, remove it. Pulp stumps of will be dressed with reinforced zinc oxide eugenol, IRM®* Tooth Preparation will be done followed by placement of stainless-steel crown
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R).The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Radiographic success
    Description
    Obvious furcation or periapical radiolucency by radiographic examination , (Internal and external) resorption by radiographic examination.
    Time Frame
    one year
    Title
    Chair side time
    Description
    Stop watch (min.s)
    Time Frame
    immediately after the procedure
    Title
    Child cooperation
    Description
    Evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)
    Time Frame
    immediately after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children: Age 4 to 7 years medically free. Primary molars with deep caries. Vital pulp with no clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Absence of swelling or pus exudate or fistula. Absence of abnormal teeth mobility Absence of pain on percussion Exclusion criteria: Patients experience signs or symptoms of pulpal or periapical pathology. Patients requiring special dental consideration. Unmotivated uncooperative patients. Patients can't attend follow up visits.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sondos A Naserallah, B.D.S
    Phone
    01141004620
    Ext
    002
    Email
    sondos.ahmed@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Passant Nagi, PhD
    Phone
    01280557107
    Ext
    002
    Email
    passant.nagi@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gihan M Abuelniel, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    SDF Modified Hall Technique Vs. Conventional Pulpotomy for Management of Carious Primary Molars

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