Comparative Evaluation of Gingival Health and Bacterial Adhesion in Bioflx vs. Zirconia Crowns on Primary Molars

Not Applicable

Not yet recruiting

• Conditions: Carious Primary Molars

• Registration Number: NCT06933927
• Lead Sponsor: Cairo University

Brief Summary

The goal of this clinical trial is to evaluate the Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question\[s\] it aims to answer is there are the differences in bacterial adhesion and gingival health between bioflx and zirconia crowns The study will also assess the clinical performance of both types of crowns in terms of bacterial adhesion , child and parents satisfaction,as well as preparation time.

Detailed Description

Dental caries is an oral disease most ubiquitous among children, characterized by a series of demineralization and remineralization cycles. If left untreated, it can progress to cavitated lesions. Usually, the familiar method of managing multi-surface carious lesions in primary teeth with stainless steel crowns .Streptococcus mutans is considered to be the main colonizer and primary etiological factor in caries progression as it stimulates the production of glucans from the food substrates. Research has indicated that S. mutans can be isolated from plaque samples. Consequently the long-term success of a restored tooth is significantly affected by the adhesion of S. mutans to the preformed crowns.Bacterial adhesion on zirconia are sparse. An in vitro study reported the initial bacterial adhesion on the surface of zirconia to be less compared with resins. When a primary tooth is restored with a full-coverage restoration, it establishes a fresh environment conducive to microbial adhesion. Bioflx Crowns the first flexible, durable, and esthetic preformedcrown for primary molars .BFCs are monochromatic, metal-free, tooth-colored crowns used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are similar to SSC in tooth preparation. Additionally, they offer a cost benefit compared to zircon crowns,

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-22
• Study Start: 2025-06-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. patients aged 4-8 years.
2. decayed in primary molars require full-coverage crowns.
3. No history of systemic diseases affecting oral health.
4. Cooperative children.

Exclusion Criteria

-patients with severe medical conditions, badly decayed in primary molars and trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival Health	6 months	plaque index using Silness\& Löe plaque index:0 - 3 0: no plaque.1: film at gingival margin.2: moderate accumulation.3: abundance of plaque.
Gingival health	6 months	Gingival index using Löe\& Silness :0 - 3 0: healthy gum.1: mild discoloration and edematous gingiva, no bleeding on probing.2: red oedematous and shiny gingiva,bleeding on probing.3: red oedematous and ulceration gingiva, spontaneous bleeding.

Secondary Outcome Measures

Name	Time	Method
Bacterial adhesion	2 weeks	Method of measurement : by( Mitis salivarius agar) Unit of measurement :Colony-formingunits.
child and parental satisfaction	6 months	5-Point likert's scale / Questionnaire.; 1. Very Happy.2. Happy.3. Neither.4. Unhappy.5. Very Unhappy.
Preparation time	6 months	Method of measurement : stop watch Unit of measurement : minutes

Trial Locations

Locations (1)

Faculty of dentistry cairo university; 🇪🇬 Cairo, Giza, Egypt