The Relation Between Oral Hygiene and Microbial Load in the Oral Cavity After Restoring Primary Molars with Two Types of Ready-made Crowns

Recruiting

• Conditions: Carious Lesion; Ready-made Crowns

• Registration Number: NCT06767670
• Lead Sponsor: Al-Azhar University

Brief Summary

Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-05
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-06-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Participants aged between 4 and 8 years.
• Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique).
• No history of any antibiotic consumption 2 weeks before the procedure.
• No history of fluoride application 2 weeks before the procedure.

Exclusion Criteria

• Special children with physical disabilities or emotional disturbances.
• Children are diagnosed with systemic diseases.
• Grossly destructed teeth with non-restorable crown structure.
• Primary teeth with shedding or pathological tooth mobility.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.	one months	Collecting the plaque samples from the gingival crevices, buccal mucosa, and occlusal surfaces of the teeth treated using sterile cotton swabs initially and from the respective crown surfaces. After collecting the samples, they will be inoculated onto a plate of Mitis salivarius-bacitracin agar (MSBA), a selective growth medium for cultivating S. mutans.

Secondary Outcome Measures

Name	Time	Method
Gingival health	one months	by measuring the gingival index (GI) Gingival Index (GI); * Purpose: Measures the severity of gingivitis based on the color, consistency, and bleeding of the gums.; * Scoring: 0: Normal gingiva; 1. Mild inflammation (slight change in color, slight edema, no bleeding).; 2. Moderate inflammation (redness, edema, and bleeding upon probing).; 3. Severe inflammation (marked redness and edema, spontaneous bleeding).
Plaque Index (PI)	one month	* Purpose: Assesses the amount of dental plaque on teeth.; * Scoring: No plaque; 1. A film of plaque adhering to the free gingival margin and adjacent areas of the tooth.; 2. Moderate accumulation of soft deposits on the gingival margin and/or the adjacent tooth surfaces.; 3. Abundance of soft matter on the tooth and gingival margin.

Trial Locations

Locations (2)

Al-Azhar University; 🇪🇬 Cairo, Nasr City, Egypt

Faculty of Dental Medicine at Al-Azhar University.; 🇪🇬 Cairo, Nasr City, Egypt