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.
Sponsors |
Lead Sponsor: Cairo University |
||||||
---|---|---|---|---|---|---|---|
Source | Cairo University | ||||||
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. |
||||||
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) |
||||||
Overall Status | Not yet recruiting | ||||||
Start Date | May 1, 2021 | ||||||
Completion Date | September 1, 2022 | ||||||
Primary Completion Date | September 1, 2021 | ||||||
Phase | N/A | ||||||
Study Type | Interventional | ||||||
Primary Outcome |
|
||||||
Secondary Outcome |
|
||||||
Enrollment | 120 | ||||||
Condition | |||||||
Intervention |
Intervention Type: Procedure Intervention Name: SDF Description: 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 Arm Group Label: SDF Other Name: Silver Diamine Fluoride Intervention Type: Procedure Intervention Name: Hall technique Description: 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 Arm Group Label: Hall Technique |
||||||
Eligibility |
Criteria:
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 Gender: All Minimum Age: 4 Years Maximum Age: 6 Years Healthy Volunteers: No |
||||||
Overall Contact |
Last Name: gihan abo el neil,, professor |
||||||
Verification Date |
February 2021 |
||||||
Responsible Party |
Type: Principal Investigator Investigator Affiliation: Cairo University Investigator Full Name: Mostafa Amin Mahmoud El.byoumi Investigator Title: principle investigator |
||||||
Keywords | |||||||
Has Expanded Access | No | ||||||
Number Of Arms | 2 | ||||||
Arm Group |
Label: Hall Technique Type: Active Comparator Description: The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding drilling Label: SDF Type: Experimental Description: 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 |
||||||
Patient Data | Yes | ||||||
Study Design Info |
Allocation: Non-Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: None (Open Label) Masking Description: not possible, since interventions are different |