The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars

Caries Clinical Trial

Official title:

The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04889196
• Other study ID #: 120
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: Sarah A Abdalla, B.S.S
• Phone: 01064038625
• Email: sarah.ibrahim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PICO question:

In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?

population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:

Primary outcome:

Gingival health measurement device modified gingival index, measurement unit score(0-1-2)

Secondary outcomes:

1. Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)

2. Time of Treatment measurement device digital chronometer, measurement unit minutes

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 method

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: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Age: From 4 to 6 years

• Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion Criteria:

• Tooth with signs and symptoms of pulp necrosis

• Tooth with Root caries

• Tooth with Spontaneous pain

Related Conditions & MeSH terms

• Caries

Intervention

Drug:
• Silver diamine fluoride
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)

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
Sarah Abdalla Ibrahim Abdalla

References & Publications (1)

Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival health	Modified Gingival index (0 = no swelling; = mild swelling, no bleeding after gentle probing; = moderate to severe gingival swelling, bleeding after air drying	up to 1 day
Primary	Gingival health	Modified Gingival index (0 = no swelling; = mild swelling, no bleeding after gentle probing; = moderate to severe gingival swelling, bleeding after air drying	at 3 months
Primary	Gingival health	Modified Gingival index (0 = no swelling; = mild swelling, no bleeding after gentle probing; = moderate to severe gingival swelling, bleeding after air drying	at 6 months
Secondary	Oral hygiene	Modified Plaque index(0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	up to one day
Secondary	Oral hygiene	Modified Plaque index(0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	at 3 months
Secondary	Oral hygiene	Modified Plaque index (0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	at 6 months
Secondary	Treatment time	Digital chronometer	during procedure
Secondary	Treatment time	Digital chronometer	during procedure in the second application at 6 monthes

External Links

•   A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan.