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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-8
SponsorAl-Azhar University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • stainless steel crown

    Other intervention

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

  • bioflex crown

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group S1 intervention
Group B: Group B1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
one months

Secondary outcomes

1

Gingival health

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).

Time frame
one months
2

Plaque Index (PI)

* 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.

Time frame
one month

Other outcomes

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