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

Not Applicable

Not yet recruiting

• Conditions: Decayed Primary Molars
• Interventions: Procedure: ART; Procedure: Hall technique

• Registration Number: NCT06591143
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• 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: 46

Inclusion Criteria

• Age: From 4 to 6 years.
• Caries in primary molars within enamel/dentin with vital pulp.
• Healthy children.
• Cooperative children.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART	ART	Atraumatic restorative treatment
Hall technique	Hall technique	Stainless steel crown placement without tooth preparation

Primary Outcome Measures

Name	Time	Method
Periodontal health	initial, 3 months, 6 months, 12 months	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)

Secondary Outcome Measures

Name	Time	Method
Gingival index	Initial, 3 months, 6 months, 12 months	While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) (0= no swelling, 2= Moderate to severe gingival swelling, bleeding after air drying)
Postoperative pain and discomfort	Immediately postoperative	Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R) (0= no pain, 10=worst)
Child behaviour	Intraoperative	Venham Anxiety Rating Scale (0= total cooperation, best possible working conditions, no crying or physical protest, 5= general protest, no cooperation, physical restraint is required)
Child anxiety	Intraoperative	Venham Anxiety Rating Scale (0= relaxed, smiling, willing, and able to converse, 5= loud crying unable to listen to verbal communication)
Canine overbite	Initial, 3 months, 6 months, 12 months	The canine overbite will be calculated before the preparation by measuring the distance between the incisal points of the maxillary canine on the same side of the mouth to the gingival zenith of the mandibular canine using a Boley Gauge

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt