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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04794426
• Other study ID #: 113
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: Noura M Alhosaini, B.D.S
• Phone: 01115877726
• Email: noura.talat[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 29, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Pain, Postoperative

Intervention

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)

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Noura Mohamed Alhosaini

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative pain	Face 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.	at 2 days
Primary	post-operative pain	Face 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.	at 1 week
Primary	post-operative pain	Face 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.	at 2 weeks
Primary	post-operative pain	Face 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.	at 1 month
Primary	post-operative pain	Face 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.	at 6 months
Secondary	Child Anxiety	Venham 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	Immediately
Secondary	Child behavior	Venham 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	Immediately
Secondary	Intra operative pain	Face 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.	Immediately

External Links

•   Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth