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

NCT06589622 | Not Yet Recruiting DMC

• 1 other identifier: ART vs Hall technique
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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)

Conditions

Decayed Primary Molars

Keywords

ART; Hall technique; decayed primary molars

Outcome Measures

Primary Outcomes (1)

• Major failure

  Irreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.

  1 year follow up

Secondary Outcomes (4)

• Canine overbite

  3 months, 6 months and 1 year follow up

• Postoperative pain and discomfort

  Immediately postoperative

• Child anxiety

  Intraoperative

• Child behavior

  Intraoperative

Study Arms (2)

ART

EXPERIMENTAL

Atraumatic restorative technique

Procedure: Atraumatic Restorative Treatment

Hall technique

EXPERIMENTAL

Stainless steel crown placement without tooth preparation

Procedure: Hall technique

Interventions

Atraumatic Restorative Treatment PROCEDURE

Caries excavation with hand instruments only and restoration with Glass ionomer filling

ART

Hall technique PROCEDURE

Crown placement without tooth preparation

Hall technique

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.
• Cooperative children
• Children with no systemic disease, occlusal problems or bad habits.
• Primary molars with vital pulp.
• Class II Caries in primary molars within enamel/dentin.
• Molars in occlusion with the antagonist tooth/teeth.
• Teeth with no developmental anomalies.
• Absence of spontaneous pain and tenderness to percussion.
• Absence of any radiolucency in furcation and/or periradicular regions.
• No pathological and internal/external resorption.

You may not qualify if:

• Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).
• Root caries.
• History of Spontaneous pain.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

EG (1)