Clinical trial NCT05249231: Parental Satisfaction of Hall Technique Versus SDF in the Management of Carious Primary Molars
Official title: Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: parental satisfaction of Hall technique versus silver diamine fluoride
timeFrame: during procedure
Secondary outcomes:
measure: treatment time
timeFrame: during procedure
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherif B Eltaweil, prof
role: STUDY_DIRECTOR
References:
citation: Ebrahimi M, Shirazi AS, Afshari E. Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth. Pediatr Dent. 2020 May 15;42(3):187-192.