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

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

• 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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadeer E alazhary, B.D.S; Phone Number: +2 01022593594; Email: hadeer.rizk@dentistry.cu.edu.eg
• Study Contact Backup: Name: Ahmed M Elkhadem, assistant professor; Phone Number: +2 01064440888; Email: Ahmed.Elkhadem2@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:

• 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

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: Hall technique; group of carious primary molars to be treated by 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; Other Names: HT
Experimental: silver diamine fluoride; group of carious primary molars to be treated by silver diamine fluoride	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); Other Names: SDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Sherif B Eltaweil, prof, Cairo University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 6393 (NYSPI IRB)

Drug and device information, study documents

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