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Clinical Trials/NCT04765904
NCT04765904UnknownNot Applicable

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

Cairo University0 sites120 target enrollmentStarted: August 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
120
Primary Endpoint
percentage of Treatment failure:

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

not possible, since interventions are different

Eligibility Criteria

Ages
4 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

percentage of Treatment failure:

Time Frame: 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 Outcomes

  • Canine overbite(one year)
  • Arresting caries in SDF(one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mostafa Amin Mahmoud El.byoumi

principle investigator

Cairo University

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