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

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

Study Overview

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

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Noura M Alhosaini, B.D.S; Phone Number: 002 01115877726; Email: noura.talat@dentistry.cu.edu.eg
• Study Contact Backup: Name: Ahmed m Elkhadem, Ass. Prof; Phone Number: 002 01064440888; Email: Ahmed.Elkhadem@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
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

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: control group; The group that have caries in primary molars and treat them with 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.
Experimental: experimental group; 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Noura Mohamed Alhosaini
• Investigators: Study Chair: 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): June 1, 2021
• Primary Completion (Anticipated): July 20, 2022
• Study Completion (Anticipated): July 29, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 113 (Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes