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

May 11, 2026 updated by: Alaa M Eldehna, Al-Azhar University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt
        • Recruiting
        • Al-Azhar University
      • Cairo, Nasr City, Egypt
        • Not yet recruiting
        • Faculty of Dental Medicine at Al-Azhar University.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alaa m. Eldehna, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A total of 10 patients 4-8 years old will be selected according to the established inclusion and exclusion criteria. The study will be conducted on patients attending the outpatient clinic of the pediatric dentistry department, Faculty of Dental Medicine Al-Azhar.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group S
teeth subjected to SSC on one side
Other: stainless steel crown
familiar method of managing multi-surface carious lesions in primary teeth
Group B
teeth subjected to Bioflx crowns on the contralateral side
Other: bioflex crown
aesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

    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).
one months
Plaque Index (PI)
Time Frame: 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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Alaa Mohammed Eldehna, Assistant Proffessor, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-PD-25-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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