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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Caries
• Intervention / Treatment: Drug: Silver diamine fluoride; Device: hall technique

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sarah A Abdalla, B.S.S; Phone Number: 002 01064038625; Email: sarah.ibrahim@dentistry.cu.edu.eg
• Study Contact Backup: Name: Ahmed B Elkhadem, Ass.Prof; Phone Number: 002 01064440888; Email: Ahmed.Elkhadem@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; The group that have caries in primary molars and treat them with hall technique	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.
Experimental: experimental group; 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral hygiene	Modified Plaque index(0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	up to one day
Oral hygiene	Modified Plaque index(0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	at 3 months
Oral hygiene	Modified Plaque index (0 = no plaque; = thin visible plaque, difficult to identify; = thick visible plaque, easily detected	at 6 months
Treatment time	Digital chronometer	during procedure
Treatment time	Digital chronometer	during procedure in the second application at 6 monthes

Collaborators and Investigators

• Sponsor: Sarah Abdalla Ibrahim Abdalla
• Investigators: Study Chair: sherif B Eltaeil, Prof, Cairo University

Publications and helpful links

General Publications

• 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 2019.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): May 20, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 120 (Tumor Vaccine Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No