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

NCT06933927 | Not Yet Recruiting

• 1 other identifier: EGHBA-BFXZRC-PM-2025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (3)

• Bacterial adhesion

  2 weeks

• child and parental satisfaction

  6 months

• Preparation time

  6 months

Study Arms (2)

Bioflex crowns

EXPERIMENTAL

Bioflx Crowns (BFCs) 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

Other: (Group A: Bioflx crowns)

Zirconia crowns

EXPERIMENTAL

zirconia crowns are frequently chosen as a comparator due to their established clinical performance and favorable biological properties. Studies have demonstrated that zirconia crowns exhibit lower bacterial adhesion, particularly of Streptococcus mutans, compared to stainless steel crowns (SSCs). highly polished and smooth surface of zirconia, which minimizes plaque accumulation and subsequent gingival inflammation.

Other: (Group B) : Preformed Zirconia crown

Interventions

(Group A: Bioflx crowns) OTHER

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

Bioflex crowns

(Group B) : Preformed Zirconia crown OTHER

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

Zirconia crowns

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients aged 4-8 years.
• decayed in primary molars require full-coverage crowns.
• No history of systemic diseases affecting oral health.
• Cooperative children.

You may not qualify if:

• patients with severe medical conditions, badly decayed in primary molars and trauma.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (2)

• 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.

  PMID: 38616425 BACKGROUND

• 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.

  PMID: 23263423 BACKGROUND

Study Officials

• Manal Ahmed Elsheikh, PHD

  Cairo University

  STUDY DIRECTOR

• Shaimaa Mohamed Sabry mostafa, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Salma Ahmed Abdelrazig, Master degree

CONTACT

00201022584032; Salma.abdelrazig@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 18, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 26, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

EG (1)