Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars

NCT06450093 | Recruiting

• 1 other identifier: A0103024PP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to: Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.

Conditions

Dental Restoration

Keywords

Bioflx Crowns; Wear; Zirconia Crowns; stainless steel Crowns; periodontal changes

Outcome Measures

Primary Outcomes (7)

• Crown retention

  The crown retention will be measured concerning the proper adaptation of the crown or the complete crown loss according to the following: 0 = present. 1 = absent.

  After 3, 6,12,18 months

• Color stability

  The color stability will be evaluated using one crown from the original kit as a standard that will be held up to each crown restoration for color comparison according to the following: 0= Unchanged. 1= Minor deviation from original. 2 = Unacceptable discoloration.

  After 3, 6,12,18 months

• Secondary caries

  Secondary caries will be measured according to USPHS by visual inspection with an explorer to inspect if there is evidence of caries with the margin of the crown restoration according to the following: 0 = no caries 1 = caries present

  After 3, 6, 12,18 months

• Gingival Index (Periodontal Changes)

  The GI (Gingival index) will be measured by the William Gingival Probe; the values will be recorded according to the following: 0 = normal gingiva 1. = mild inflammation: a slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation: redness, edema, glazing, or bleeding on probing 3. = severe inflammation: marked redness or edema, a tendency toward spontaneous bleeding, and ulceration.

  After 3, 6, 12 ,18 months

• Periodontal Index (Periodontal changes)

  The PI (Periodontal Index) will be measured by the William Gingival probe; the values will be recorded according to the following: 0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.

  After 3, 6, 12 ,18 months

• Periodontal pocket depth (Periodontal changes)

  The PPD will be measured using a manual periodontal probe (UNC. 15 mm) according to the following: The pocket depth will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and then move in a walking fashion.

  After 3, 6, 12 ,18 months

• Wear of the opposing natural enamel.

  To evaluate the wear of the antagonistic natural enamel of the primary molar, alginate impressions will be taken immediately (baseline) and 1 year after cementation of the crowns. The resulting casts will be scanned using a 3D scanner and 3D software that will be used to calculate the maximum amount of linear wear using image superimposition techniques. The occlusal points of the crowns will be recorded in the software for measurements and comparisons, then it will be transformed into Standard Tessellation Language (STL) file format by the software

  After 12 months

Study Arms (3)

Group I Stainless steel crowns (control group)

OTHER

It will include 17 molars that will be restored by a stainless steel crown.

Other: Preformed stainless steel crown.

Group II: Preformed zirconia crown (study group)

OTHER

It will include 17 molars that will be restored by Zirconia crowns.

Other: Preformed zirconia crown

Group III: Preformed BioFlx crown (study group)

OTHER

It will include 17 molars that will be restored by BioFlx crowns.

Other: Preformed BioFlx crown

Interventions

Preformed stainless steel crown. OTHER

A well-fitted preformed stainless-steel crown will be chosen by measuring the mesiodistal dimension of the tooth or its contralateral counterpart, using a graduated periodontal probe for guidance. (6) Tooth preparation will be carried out with #835 diamond fissure bur to reduce occlusal surface up to 1 to 1.5 mm. The interproximal reduction will be made mesially and distally using #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. The selected crown size will be checked, and a trial fit will be done before cementation. The crown will be cemented using self-cured RMGI luting cement. The excess will be removed, and proper occlusion will be checked.

Group I Stainless steel crowns (control group)

Preformed zirconia crown OTHER

The material for crown restoration for this group is the preformed zirconia crown. Tooth preparation will be started by occlusal reduction (1 to 1.5 mm) using #835 diamond fissure bur. The interproximal reduction will be done mesially and distally with #169 L tapered diamond bur in such a way that a straight probe passes freely through the contact area. Rounding of line angles will be done and a knife-edge finish margin of the proximal surface will be obtained avoiding any ledge formation. The selected crown will be placed and checked for a passive fit. Consistent firm finger pressure will be applied during cementation with self-cured RMGI luting cement. Finally, crown placement will be checked.

Group II: Preformed zirconia crown (study group)

Preformed BioFlx crown OTHER

The prefabricated BioFlx crown will be used in this group. A similar-sized preformed crown will be selected. Tooth preparation will be carried out similarly to traditional SSCs with #835 diamond fissure bur for occlusal reduction by 1-1.5 mm including the central groove. The proximal preparation will be done mesially and distally with #169 L tapered diamond bur around 0.5 mm to clear the contact area creating a feather edge finish line. Placement of the crown will be achieved by a snug fit. Crown cementation will be carried out using self-cured RMGI luting cement and the excess cement will be removed using a floss or an explorer. (13) Finally, crown placement will be checked

Group III: Preformed BioFlx crown (study group)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are free from any systemic disease.
• Children with a carious lower primary molar indicated for crown restoration.
• Teeth with an intact antagonist and neighboring primary molar.
• Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.

You may not qualify if:

• Children with extremely poor oral hygiene.
• Teeth showing radiographical furcation involvement or root resorption.
• Children with para-functional habits, bruxism, or deep bite.
• Teeth with inadequate non-restorable crown structure.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University.

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Central Study Contacts

Heba 0. Elbadry

CONTACT

+201116121999; Hebaaelbadry@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, peadiatric dentistry department

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 10, 2024
• Study Start: April 4, 2024
• Primary Completion: October 4, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)