Carious Primary Molars
Conditions
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,
Interventions
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
OTHER(Group B) : Preformed Zirconia crown
1\. Size Determination can be achieved by holding a crown up to the existing tooth or, if available, using digital x-ray measurements to match the patient's interproximal width to the corresponding crown size.2. OcclusalPerform an occlusal reduction of about 1.5-2 mm, ensuring adequate space for the crown material. 3. Axial ReductionReduce the buccal and lingual surfaces uniformly, ensuring the removal of any prominent buccal bulges to allow for a passive crown fit. 4. Interproximal ReductionClearance: Ensure sufficient interproximal space by removing enough tooth structure to allow the crown to seat without interference.5. Subgingival PreparationMargin Placement: Extend the preparation subgingivally by approximately 2 mm to achieve optimal crown retention and aesthetics. This involves removing the chamfer margin at the tissue level and ensuring a smooth transition from the root to the coronal tooth structure
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactSalma Ahmed Abdelrazig, Master degree
Outcome results
None listed