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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05249231
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Anticipated Duration (Months): 3.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Caries	Drug: Silver diamine fluoride; Device: Hall technique	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. parental satisfaction of Hall technique versus silver diamine fluoride [during procedure]

   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)

Secondary Outcome Measures

1. treatment time [during procedure]

   Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Hadir Emad, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05249231
• Other Study ID Numbers: 6393
• First Posted: Feb 21, 2022
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fluorides

Study Results

No Results Posted as of Feb 21, 2022