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

Not Applicable

• Conditions: Early Childhood Caries
• Interventions: Procedure: Hall technique; Procedure: SDF

• Registration Number: NCT04765904
• Lead Sponsor: 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)

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-23
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Study Start: 2021-08-01
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hall Technique	Hall technique	The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding drilling
SDF	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

Primary Outcome Measures

Name	Time	Method
percentage of Treatment failure:	one year	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 ).

Secondary Outcome Measures

Name	Time	Method
Canine overbite	one year	measure the canine over bite discrepancy by Boley Gauge by Millimeter
Arresting caries in SDF	one year	assess caries activity according to (ICDAS) through Codes 0-1-2-3-4-5-6