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Post-operative Pain and Child Behavior of Hall Technique Versus SDF in the Management of Carious Primary Molars: RCT

Post-operative Pain and Child Behavior of Hall Technique Versus Silver Diamine Fluoride in the Management of Carious Primary Molars: Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04794426
Enrollment
40
Registered
2021-03-12
Start date
2021-06-01
Completion date
2022-07-29
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries

Brief summary

PICO question: Papulation: children suffering from caries Intervention: Silver Diamine Fluoride Comparison: Hall technique Outcome: Primary Outcome: Intraoperative and postoperative pain Measurement device: Face pain scale Revised8 Measurement unit: Score 0-2-4-6-8-10 Secondary Outcome: 1. Child Anxiety Measurement device: Venham Anxiety rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5 2. Child Behavior Measurement device: Venham Behavior rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5

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 1. 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 method2. 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) 3

Interventions

DRUGSilver 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)

DEVICEHall 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.

Sponsors

Noura Mohamed Alhosaini
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: From 4 to 6 years 2. Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion criteria

1. Tooth with signs and symptoms of pulp necrosis 2. Tooth with Root caries 3. Tooth with Spontaneous pain

Design outcomes

Primary

MeasureTime frameDescription
post-operative painat 2 daysFace Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

Secondary

MeasureTime frameDescription
Child AnxietyImmediatelyVenham Anxiety rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
Child behaviorImmediatelyVenham behavior rating scale is a reliable system for rating behavior of children in the dental setting. Six-point scales 0-1-2-3-4-5
Intra operative painImmediatelyFace Pain Scale Revised Immediately after the treatment, any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R). Each child was asked to mark the face that reflected her or his experienced pain during the treatment. The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

Contacts

Primary ContactNoura M Alhosaini, B.D.S
noura.talat@dentistry.cu.edu.eg01115877726
Backup ContactAhmed m Elkhadem, Ass. Prof
Ahmed.Elkhadem@dentistry.cu.edu.eg01064440888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026