About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 4-8 years.
decayed in primary molars require full-coverage crowns.
No history of systemic diseases affecting oral health.
Cooperative children.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
(Group A: Bioflx crowns)
Other interventionMinimal 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
(Group B) : Preformed Zirconia crown
Other intervention1\. 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
Treatment groups
Trial outcomes
Primary outcomes
Gingival Health
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
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 outcomes
Bacterial adhesion
Method of measurement : by( Mitis salivarius agar) Unit of measurement :Colony-formingunits.
child and parental satisfaction
5-Point likert's scale / Questionnaire. 1\. Very Happy.2. Happy.3. Neither.4. Unhappy.5. Very Unhappy.
Preparation time
Method of measurement : stop watch Unit of measurement : minutes
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: