Faculty of dentistry cairo university
Cairo, Giza Governorate, 12613, Egypt
NCT Number: NCT06933927
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.
Trial opening soon.
Get Notified4 year–8 year
All sexes
Interventional
Not applicable
Cairo, Giza Governorate, 12613, Egypt
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,
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-patients with severe medical conditions, badly decayed in primary molars and trauma.
Minimal preparation will be required due to their flexural adaptability:1. Choose an appropriately sized Bioflex (Nusmile) crown of similar size to the mesiodistal width.2. The tooth will be prepared using a flame stone for occlusal reduction by 1-1.5 mm, including the central groove .3Proximal preparation will be around 0.5 mm, by using a fine, long, tapered diamond stone to cut interproximal slices mesially and distally.4. The crown will be placed with a snug fit and cemented using glass ionomer
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
Method of measurement : by( Mitis salivarius agar) Unit of measurement :Colony-formingunits.
Time frame: 6 months
5-Point likert's scale / Questionnaire.
Time frame: 6 months
Method of measurement : stop watch Unit of measurement : minutes
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Evaluation of Gingival Health and Bacterial Adhesion of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars: A Randomized Clinical Trial
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