Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old

Not Applicable

Not yet recruiting

• Conditions: Decayed Primary Molars

• Registration Number: NCT06589622
• Lead Sponsor: Cairo University

Brief Summary

This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-13
• Study Start: 2024-10-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major failure	1 year follow up	Irreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.

Secondary Outcome Measures

Name	Time	Method
Canine overbite	3 months, 6 months and 1 year follow up
Postoperative pain and discomfort	Immediately postoperative	Face pain scale-revised Its a self report measure of pain intenisty from 0 to 10 with 0 being least painful and 10 being most painful
Child anxiety	Intraoperative	Venham anxiety rating scale is a scale from 0 to 5 assessing the anxiety of children in dental setting with 0 being most relaxed and smiling and 5 being most anxious and out of contact with the reality of the threat.
Child behavior	Intraoperative	Venham behavior rating scale Its a scale from 0-5 with 0 being total cooperation and 5 being total uncooperation and physical restraint is required.

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt