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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04737057
Collaborator
(none)
72
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: SDF
  • Procedure: Hall technique
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
not possible, since interventions are different
Primary Purpose:
Treatment
Official Title:
Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Child's behavior [immediately after the procedure]

      evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)

    Secondary Outcome Measures

    1. Canine overbite [one year]

      measure the canine over bite discrepancy by Boley Gauge by Millimeter

    2. Arresting caries in SDF [one year]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: gihan abo el neil, professor, Cairo University
    • Study Director: ahmed alkhadem, assistant professor, Cairo univeristy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lamiaa Saeed Ahmed Elshiekh, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04737057
    Other Study ID Numbers:
    • CairoU1234
    First Posted:
    Feb 3, 2021
    Last Update Posted:
    Feb 5, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lamiaa Saeed Ahmed Elshiekh, principle investigator, Cairo University
    hall technique
    Silver diamide fluoride
    non invasive technique
    Additional relevant MeSH terms:
    Fluorides

    Study Results

    No Results Posted as of Feb 5, 2021