Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar.
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 3, 2021
July 1, 2021
1 month
February 12, 2021
July 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of Treatment failure:
1. Obvious furcation or periapical radiolucency by radiographic examination. 2. (Internal and external) resorption by radiographic examination. 3. Sensitivity to percussion by clinical examination ( dental mirror ). 4. Loss of SSC crown by clinical examination ( visual examination ).
one year
Secondary Outcomes (2)
Canine overbite
one year
Arresting caries in SDF
one year
Study Arms (2)
Hall Technique
ACTIVE COMPARATORThe Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding drilling
SDF
EXPERIMENTALa 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Age: From 4 to 6 years
- Caries in primary molars within enamel/dentin without pulp disease
You may not qualify if:
- Presence of signs and symptoms of necrosis
- Root caries
- Spontaneous pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Gihan Abuelniel, professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- not possible, since interventions are different
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 23, 2021
Study Start
August 1, 2021
Primary Completion
September 1, 2021
Study Completion
September 1, 2022
Last Updated
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 2 years