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

NCT04737057 | Unknown

• 1 other identifier: CairoU1234
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: 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.

Conditions

Early Childhood Caries

Keywords

hall technique; Silver diamide fluoride; non invasive technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Canine overbite

  one year

• Arresting caries in SDF

  one year

Study Arms (2)

Hall Technique

ACTIVE COMPARATOR

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; Procedure: Hall technique

SDF

EXPERIMENTAL

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; Procedure: Hall technique

Interventions

SDF PROCEDURE

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

Also known as: Silver Diamine Fluoride

Hall Technique; SDF

Hall technique PROCEDURE

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

Hall Technique; SDF

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• gihan abo el neil, professor

  Cairo University

  STUDY CHAIR

• ahmed alkhadem, assistant professor

  Cairo univeristy

  STUDY DIRECTOR

Central Study Contacts

lamia S El-Sheikh, bachelor

CONTACT

+2 01004733637; lamiaa.alsheikh@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: January 20, 2021
• First Posted: February 3, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2 years