- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04765904
Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar.
Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar: Randomized Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description:
Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2
Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gihan Abuelniel, professor
- Phone Number: +201002807060
- Email: gihan.abuelniel@dentistry.cu.edu.eg
Study Contact Backup
- Name: Ahmed Elkhadem, Associate Professor
- Email: ahmed.elkhadem@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: From 4 to 6 years
- Caries in primary molars within enamel/dentin without pulp disease
Exclusion Criteria:
- Presence of signs and symptoms of necrosis
- Root caries
- Spontaneous pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hall Technique
The Hall Technique is a non-invasive treatment for decayed molar teeth.
Decay is sealed under preformed (stainless steel) crowns, avoiding drilling
|
Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.)
2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up
|
Experimental: SDF
a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a topical therapeutic agent for managing caries lesions in young children
|
1)Dry with cotton to affected tooth surfaces 2) Apply the SDF material 3)Dry with a gentle flow of compressed air for at least one minute.
and Remove excess SDF with gauze
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of Treatment failure:
Time Frame: one year
|
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine overbite
Time Frame: one year
|
measure the canine over bite discrepancy by Boley Gauge by Millimeter
|
one year
|
Arresting caries in SDF
Time Frame: one year
|
assess caries activity according to (ICDAS) through Codes 0-1-2-3-4-5-6
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gihan Abuelniel, professor, Cairo University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CairoU 1357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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