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

Noura Mohamed Alhosaini

Status and phase: Unknown; Phase 3

Conditions: Caries

Treatments: Drug: Silver diamine fluoride; Device: Hall Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04794426

113

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

control group

Active Comparator group

Description:

The group that have caries in primary molars and treat them with Hall Technique

Treatment:

Device: Hall Technique

experimental group

Experimental group

Description:

The group that have caries in primary molars and treat them with Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC.

Treatment:

Drug: Silver diamine fluoride