Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar.

Early Childhood Caries Clinical Trial

Official title:

Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar: Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04765904
• Other study ID #: CairoU 1357
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Gihan Abuelniel, professor
• Phone: +201002807060
• Email: gihan.abuelniel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Procedure:
• SDF
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
• Hall technique
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of Treatment failure:	Obvious furcation or periapical radiolucency by radiographic examination.; (Internal and external) resorption by radiographic examination.; Sensitivity to percussion by clinical examination ( dental mirror ).; Loss of SSC crown by clinical examination ( visual examination ).	one year
Secondary	Canine overbite	measure the canine over bite discrepancy by Boley Gauge by Millimeter	one year
Secondary	Arresting caries in SDF	assess caries activity according to (ICDAS) through Codes 0-1-2-3-4-5-6	one year