Clinical trial NCT06933927: Comparative Evaluation of Gingival Health and Bacterial Adhesion in Bioflx vs. Zirconia Crowns on Primary Molars
Official title: Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carious Primary Molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival Health
timeFrame: 6 months
measure: Gingival health
timeFrame: 6 months
Secondary outcomes:
measure: Bacterial adhesion
timeFrame: 2 weeks
measure: child and parental satisfaction
timeFrame: 6 months
measure: Preparation time
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Manal Ahmed Elsheikh, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Shaimaa Mohamed Sabry mostafa, PHD
role: STUDY_DIRECTOR
References:
citation: Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.
citation: Bin AlShaibah WM, El-Shehaby FA, El-Dokky NA, Reda AR. Comparative study on the microbial adhesion to preveneered and stainless steel crowns. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):206-11. doi: 10.4103/0970-4388.105012.