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

NCT06767670 | Recruiting DMC

• 1 other identifier: P-PD-25-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Carious Lesion; Ready-made Crowns

Keywords

primary crowns,; oral health

Outcome Measures

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.

  one months

Secondary Outcomes (2)

• Gingival health

  one months

• Plaque Index (PI)

  one month

Study Arms (2)

Group S

teeth subjected to SSC on one side

Other: stainless steel crown

Group B

teeth subjected to Bioflx crowns on the contralateral side

Other: bioflex crown

Interventions

stainless steel crown OTHER

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

Group S

bioflex crown OTHER

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

Group B

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Al-Azhar University

Cairo, Nasr City, Egypt

RECRUITING

Faculty of Dental Medicine at Al-Azhar University.

Cairo, Nasr City, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Alaa Mohammed Eldehna, Assistant Proffessor

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Mohammed Eldehna, Assistant Proffessor

CONTACT

02001068837641; alaaaldehna.26@azhar.edu.eg

Aytallah Mohammed Sallem, Assistant Proffessor

CONTACT

02001068837641; ayasalem.26@azhar.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant proffesor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 5, 2025
• Primary Completion: June 6, 2025
• Study Completion: July 1, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

EG (2)