Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars

NCT06591143 | Not Yet Recruiting

• 1 other identifier: HT Vs ART
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.

Conditions

Decayed Primary Molars

Keywords

Decayed primary molars ART Hall technique

Outcome Measures

Primary Outcomes (1)

• Periodontal health

  While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) using plaque index (0: no plaque, 2: thick visible plaque easily detected)

  initial, 3 months, 6 months, 12 months

Secondary Outcomes (5)

• Gingival index

  Initial, 3 months, 6 months, 12 months

• Postoperative pain and discomfort

  Immediately postoperative

• Child behaviour

  Intraoperative

• Child anxiety

  Intraoperative

• Canine overbite

  Initial, 3 months, 6 months, 12 months

Study Arms (2)

ART

EXPERIMENTAL

Atraumatic restorative treatment

Procedure: ART

Hall technique

EXPERIMENTAL

Stainless steel crown placement without tooth preparation

Procedure: Hall technique

Interventions

ART PROCEDURE

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

ART

Hall technique PROCEDURE

Stainless steel 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.
• Caries in primary molars within enamel/dentin with vital pulp.
• Healthy children.
• Cooperative children.

You may not qualify if:

• Presence of signs and symptoms of necrosis.
• Root caries.
• History of Spontaneous pain.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

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: principle investigator

Study Record Dates

• First Submitted: September 9, 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)