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

NCT ID: NCT04765904

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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)

Conditions

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Early Childhood Caries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

not possible, since interventions are different

Study Groups

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Hall Technique

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

Group Type ACTIVE_COMPARATOR

Hall technique

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

SDF

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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Silver Diamine Fluoride

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Amin Mahmoud El.byoumi

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gihan Abuelniel, professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Gihan Abuelniel, professor

Role: CONTACT

+201002807060

Ahmed Elkhadem, Associate Professor

Role: CONTACT

Other Identifiers

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CairoU 1357

Identifier Type: -

Identifier Source: org_study_id

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