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
About this trial
This is an interventional treatment trial for Deep Carious Lesions
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.
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
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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