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

Evaluation of Oral Hygiene Status in Correlation With Microbial Load in the Oral Cavity Following Restorations of Primary Molars Using Stainless Steel and Bioflex Crowns (Clinical Randomized Trial)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06767670
Acronym
bioflex crown
Enrollment
40
Registered
2025-01-10
Start date
2026-10-05
Completion date
2027-10-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious Lesion, Ready-made Crowns

Keywords

primary crowns,, oral health

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.

Interventions

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

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.one monthsCollecting 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

MeasureTime frameDescription
Gingival healthone monthsby 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.

Countries

Egypt

Contacts

CONTACTAlaa Mohammed Eldehna, Assistant Proffessor
alaaaldehna.26@azhar.edu.eg02001068837641
CONTACTAytallah Mohammed Sallem, Assistant Proffessor
ayasalem.26@azhar.edu.eg02001068837641
PRINCIPAL_INVESTIGATORAlaa Mohammed Eldehna, Assistant Proffessor

Al-Azhar University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026