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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04737057
Other study ID # CairoU1234
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date September 1, 2022

Study information

Verified date February 2021
Source Cairo University
Contact lamia S El-Sheikh, bachelor
Phone +2 01004733637
Email lamiaa.alsheikh@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date September 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Canine overbite measure the canine over bite discrepancy by Boley Gauge by Millimeter one year
Secondary 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
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