Parental Satisfaction of Hall Technique Versus SDF in the Management of Carious Primary Molars

Not Applicable

• Conditions: Caries
• Interventions: Device: Hall technique; Drug: Silver diamine fluoride

• Registration Number: NCT05249231
• Lead Sponsor: Cairo University

Brief Summary

* The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp.

* primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4

* secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

Detailed Description

dental caries is a critical disease that affects primary teeth in early childhood. It occurs through interaction between acid-producing bacteria and carbohydrates on tooth surface. progression of caries depends on several factors such as type of diet, oral hygiene, cariogenic bacterial load and salivary flow. to control caries, the life style of a child should be improved by having healthy non-cariogenic diet and proper oral hygiene.

caries can be treated by advanced non-invasive methods such as: Hall technique and Silver diamine fluoride which are based on controlling the acidic medium of a cariogenic biofilm without removal of caries thus, arresting the progression of demineralization and restoring the function of diseased molars.

The first report on 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 through a more simplified method.

Previous studies have recommended silver diamine fluoride (SDF) to arrest early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention.

The trial is seeking the measurement of effectiveness of two modalities (Hall \& SDF techniques) to achieve best acceptable treatment for caries in developing countries which have high caries index.

Study Timeline

• Study First Submitted: 2021-12-31
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Start: 2022-04
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 1 age: from 4 to 6 years old
• 2 primary molars with enamel/dentin caries without pulp exposure

Exclusion Criteria

• 1 signs and symptoms of necrosis
• 2 root caries
• 3 spontaneous pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hall technique	Hall technique	group of carious primary molars to be treated by hall technique
silver diamine fluoride	Silver diamine fluoride	group of carious primary molars to be treated by silver diamine fluoride

Primary Outcome Measures

Name	Time	Method
parental satisfaction of Hall technique versus silver diamine fluoride	during procedure	To estimate parental satisfaction with treatment, parents are going to be asked, "What's the level of your satisfaction with the treatment your child received? "Using a 4 point likert scale (very low equals 1, low equals 2, medium equals 3 and high equals 4)

Secondary Outcome Measures

Name	Time	Method
treatment time	during procedure	Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.