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Recruiting NCT06767670

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

Observational Carious Lesion Ready-made Crowns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stainless steel crown, bioflex crown.
Who it may be relevant to
Registry conditions: Carious Lesion, Ready-made Crowns. Basic parameters: 4 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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)

Overview

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

  • Other stainless steel crown
    familiar method of managing multi-surface carious lesions in primary teeth
  • Other bioflex crown
    aesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns

Primary outcome measures

  • The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions. [Time frame: one months]
Secondary outcome measures (2)
  • Gingival health [Time frame: one months]
  • Plaque Index (PI) [Time frame: one month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Egypt · 2 centers
  • Al-Azhar University — Cairo
  • Faculty of Dental Medicine at Al-Azhar University. — Cairo

Identifiers

NCT: NCT06767670 · P-PD-25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗