Deep Carious LesionsNCT05240365
SDF Modified Hall Technique Vs. Conventional Pulpotomy for Management of Carious Primary Molars
A study testing SDF modified Hall technique and Conventional pulpotomy and stainless steel crown in people with Deep Carious Lesions, run by Sondos Naserallah.
Trial 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%. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Carious Lesions
- What is being tested?
- SDF modified Hall technique and Conventional pulpotomy and stainless steel crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SDF Modified Hall Technique Versus Conventional Pulpotomy for Management of Carious Primary Molars: A Randomized Clinical Trial
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.
Read more
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.
Read the 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.
- Conditions
- Deep Carious Lesions
- Being tested
- SDF modified Hall technique, Conventional pulpotomy and stainless steel crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF modified Hall techniqueDevice
- Preparation for Hall technique and selection of the crown.
- Clinical application of SDF.
- Cementation of the selected crown.
Conventional pulpotomy and stainless steel crownDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| SDF modified Hall technique | Experimental | 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 Receives: Device: SDF modified Hall technique |
| Conventional pulpotomy and stainless steel crown | Active comparator | 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. Receives: Device: Conventional pulpotomy and stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Radiographic success
Obvious furcation or periapical radiolucency by radiographic examination , (Internal and external) resorption by radiographic examination.
Measured: one year
Chair side time
Stop watch (min.s)
Measured: immediately after the procedure
Child cooperation
Evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sondos Naserallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sondos Naserallah, Cairo University
- Investigators
- Gihan M Abuelniel, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240365
- Sponsor's protocol ID
- SDF Modified Hall
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SDF Modified Hall Technique Versus Conventional Pulpotomy for Management of Carious Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05240365
- Acronym / sponsor ID
- SDF Modified Hall
- Conditions
- Deep Carious Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sondos NaserallahUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF modified Hall technique | Experimental | Device: SDF modified Hall techniqueWhen 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 |
| Conventional pulpotomy and stainless steel crown | Active comparator | Device: Conventional pulpotomy and stainless steel crownAmputation 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDF modified Hall technique* Preparation for Hall technique and selection of the crown. * Clinical application of SDF. * Cementation of the selected crown. | Device | SDF modified Hall technique |
| Conventional pulpotomy and stainless steel crown* 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 | Device | Conventional pulpotomy and stainless steel crown |
Primary outcome
Postoperative pain
Time frame: 24 hours postoperatively
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.
3 secondary outcomes
Radiographic success
Time frame: one year
Chair side time
Time frame: immediately after the procedure
Child cooperation
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Deep Carious Lesions
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Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
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Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gihan M Abuelniel, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing SDF modified Hall technique and Conventional pulpotomy and stainless steel crown in people with Deep Carious Lesions, run by Sondos Naserallah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sondos A Naserallah, B.D.S (01141004620 ext. 002, sondos.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.