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

NCT ID: NCT06767670

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-05

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Carious Lesion Ready-made Crowns

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group S

teeth subjected to SSC on one side

stainless steel crown

Intervention Type OTHER

familiar method of managing multi-surface carious lesions in primary teeth

Group B

teeth subjected to Bioflx crowns on the contralateral side

bioflex crown

Intervention Type OTHER

aesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns

Interventions

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stainless steel crown

familiar method of managing multi-surface carious lesions in primary teeth

Intervention Type OTHER

bioflex crown

aesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Alaa M Eldehna

assistant proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa Mohammed Eldehna, Assistant Proffessor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al-Azhar University

Cairo, Nasr City, Egypt

Site Status RECRUITING

Faculty of Dental Medicine at Al-Azhar University.

Cairo, Nasr City, Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Central Contacts

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Alaa Mohammed Eldehna, Assistant Proffessor

Role: CONTACT

02001068837641

Aytallah Mohammed Sallem, Assistant Proffessor

Role: CONTACT

02001068837641

Facility Contacts

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Alaa Mohammed Eldehna, assistant proffessor

Role: primary

02001068837641

Aya Sallem, PhD

Role: backup

00201274067604

Other Identifiers

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P-PD-25-01

Identifier Type: -

Identifier Source: org_study_id

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