Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:

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.

Study Overview

• Status: Unknown
• Conditions: Early Childhood Caries
• Intervention / Treatment: Procedure: SDF; Procedure: Hall technique

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: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: From 4 to 6 years
2. Caries in primary molars within enamel / dentin without pulp disease

Exclusion Criteria:

1. Presence of signs and symptoms of necrosis
2. Root caries
3. Spontaneous pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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 injections and drilling. It is one of a number of biologically orientated strategies for managing dental decay	Procedure: SDF; Apply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze; Other Names: Silver Diamine Fluoride; Procedure: Hall technique; this technique is performed through :1) 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 to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position
EXPERIMENTAL: SDF; a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children and those with special care needs	Procedure: SDF; Apply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze; Other Names: Silver Diamine Fluoride; Procedure: Hall technique; this technique is performed through :1) 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 to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's behavior	evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canine overbite	measure the canine over bite discrepancy by Boley Gauge by Millimeter	one year
Arresting caries in SDF	assess caries activity according to International Caries Detection and Assessment System (ICDAS) through Codes 0-1-2-3-4-5-6 ,( higher scores mean a worse outcome)	one year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: gihan abo el neil, professor, Cairo University; Study Director: ahmed alkhadem, assistant professor, Cairo Univeristy

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (ACTUAL): February 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: hall technique; Silver diamide fluoride; non invasive technique
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: CairoU1234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No