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

Caries Clinical Trial

Official title:

Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05249231
• Other study ID #: 6393
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Hadeer E alazhary, B.D.S
• Phone: 01022593594
• Email: hadeer.rizk[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: July 30, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries

Intervention

Drug:
• Silver diamine fluoride
Previous studies have recommended silver diamine fluoride (SDF) to 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 result is useful in arresting early childhood caries (ECC)

Device:
• Hall technique
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 method

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parental satisfaction of Hall technique versus silver diamine fluoride	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)	during procedure
Secondary	treatment time	Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.	during procedure

External Links

•   success and behavior during atraumatic restorative treatment, the hall technique and the stainless steel crown technique for primary molar teeth