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NCT Number: NCT06767670

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

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.

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Key information

Conditions

Carious Lesion Dental Caries Ready-made Crowns Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Azhar University, Cairo, Nasr City, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stainless steel crown

Other

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

bioflex crown

Other

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

Primary outcomes

  1. The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.

    Time frame: 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 outcomes

  1. Gingival health

    Time frame: 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

    • Mild inflammation (slight change in color, slight edema, no bleeding).
    • Moderate inflammation (redness, edema, and bleeding upon probing).
    • Severe inflammation (marked redness and edema, spontaneous bleeding).

  2. Plaque Index (PI)

    Time frame: one month

    • Purpose: Assesses the amount of dental plaque on teeth.
    • Scoring:

    No plaque

    • A film of plaque adhering to the free gingival margin and adjacent areas of the tooth.
    • Moderate accumulation of soft deposits on the gingival margin and/or the adjacent tooth surfaces.
    • Abundance of soft matter on the tooth and gingival margin.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Mohammed Eldehna, Assistant Proffessor

CONTACT

[email protected]

02001068837641

Aytallah Mohammed Sallem, Assistant Proffessor

CONTACT

[email protected]

02001068837641

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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)

Acronym: bioflex crown

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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