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

Phase 3

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

• Registration Number: NCT04889196
• Lead Sponsor: Sarah Abdalla Ibrahim Abdalla

Brief 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

Detailed 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)

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-14
• Last Update Submitted: 2021-05-14
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Study Start: 2021-09-01
• Primary Completion: 2022-05-20
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Silver diamine fluoride	the group that have caries in primary molars and treat them with silver diamine fluoride (SDF) solution would exert a prevention result in managing early childhood caries ECC
control group	hall technique	The group that have caries in primary molars and treat them with hall technique

Primary Outcome Measures

Name	Time	Method
Gingival health	at 6 months	Modified Gingival index (0 = no swelling; 1. = mild swelling, no bleeding after gentle probing; 2. = moderate to severe gingival swelling, bleeding after air drying

Secondary Outcome Measures

Name	Time	Method
Oral hygiene	at 6 months	Modified Plaque index (0 = no plaque; 1. = thin visible plaque, difficult to identify; 2. = thick visible plaque, easily detected
Treatment time	during procedure in the second application at 6 monthes	Digital chronometer