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

NCT04794426 | Unknown Phase 3

• 1 other identifier: 113
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.Child Anxiety Measurement device: Venham Anxiety rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5
2. 2.Child Behavior Measurement device: Venham Behavior rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5

Conditions

Caries

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Child Anxiety

  Immediately

• Child behavior

  Immediately

• Intra operative pain

  Immediately

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Device: Hall Technique

experimental group

EXPERIMENTAL

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

Interventions

Silver diamine fluoride DRUG

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)

experimental group

Hall Technique DEVICE

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.

control group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Tooth with signs and symptoms of pulp necrosis
• Tooth with Root caries
• Tooth with Spontaneous pain

Sponsors & Collaborators

• Noura Mohamed Alhosaini: lead

Related 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.

  PMID: 32522320 RESULT

Related Links

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

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• Sherif B Eltaweil, Prof

  Cairo University

  STUDY CHAIR

Central Study Contacts

Noura M Alhosaini, B.D.S

CONTACT

01115877726; noura.talat@dentistry.cu.edu.eg

Ahmed m Elkhadem, Ass. Prof

CONTACT

01064440888; Ahmed.Elkhadem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 12, 2021
• Study Start: June 1, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 29, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share