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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • (Group A: Bioflx crowns)

    Other intervention

    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

  • (Group B) : Preformed Zirconia crown

    Other intervention

    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

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Bioflex crownsExperimental treatment 1 intervention
Group B: Zirconia crownsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months

Secondary outcomes

1

Bacterial adhesion

Method of measurement : by( Mitis salivarius agar) Unit of measurement :Colony-formingunits.

Time frame
2 weeks
2

child and parental satisfaction

5-Point likert's scale / Questionnaire. 1\. Very Happy.2. Happy.3. Neither.4. Unhappy.5. Very Unhappy.

Time frame
6 months
3

Preparation time

Method of measurement : stop watch Unit of measurement : minutes

Time frame
6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of dentistry cairo university Status unavailable 12613, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

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