Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial

NCT07156838 | Completed

• 1 other identifier: 1003-11/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

• The goal of this clinical trial is to evaluate the clinical effectiveness of bioflex crowns and zirconia crowns compared to stainless steel crowns when
• restoring primary molars 45 participant who their ages range between 6 and 8 years participated in this study. The participants will be divided into three groups: group (A) for Bioflex crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15). The periodontal health will be evaluated using gingival index and plaque index .Clinical success will be assessed according to the Modified United States Public Health Service Evaluation (USPHS) criteria regarding: crown retention ,marginal integrity, surface roughness and color change. Moreover, parental and child satisfaction will be evaluated.

Conditions

Badly Decayed Primary Molars; Preformed Pediatric Posterior Crowns

Keywords

bioflex crown; zerconia crown; stainless steel crown; clinical success

Outcome Measures

Primary Outcomes (1)

• gingival health

  Evaluated using the gingival index, with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation).

  follow up at 3,6 and 9 months

Secondary Outcomes (7)

• plaque accumulation

  3,6 and 9 months

• crown retention

  3,6 and 9 months

• marginal integrity

  3,6 and 9 months

• color change

  3,6 and 9 months

• surface roughness

  3,6 and 9 months

Study Arms (3)

bioflex crown

EXPERIMENTAL

Other: bioflex crown

zerconia crown

EXPERIMENTAL

Other: zerconia crown

stainless steel crown

ACTIVE COMPARATOR

Other: stainless steel crown

Interventions

bioflex crown OTHER

A preformed bioflex crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area, bioflex crown fitting and proper occlusion will be checked then it will be cemented using type-I glass ionomer cement, Any excess cement will be removed.

bioflex crown

zerconia crown OTHER

Occlusal reduction will be done by 1-1.5 mm using coarse football shaped diamond bur following the natural occlusal anatomy. Interproximal contacts will be opened with a tapered fissure bur. The proximal space should be enough to permit the chosen crown to fit passively. The molar will be trimmed down circumferentially 0.5-1.25 mm as needed with the use of tapered diamond burs. •About 1 to 2 mm subgingival preparation will be done to achieve a feather-edge finish line. Prepared tooth should be free from any blood or saliva. Try-in will be done using the pink crowns, to check the occlusion and Passive fit of the crown. The zirconia crown will be luted with type I glass ionemer cement. Consistent firm finger pressure will be applied during cementation, Any excess cement will be removed, and proper occlusion will be verified

zerconia crown

stainless steel crown OTHER

An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified

stainless steel crown

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are free from any systemic disease.
• Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
• Children with good to fair oral hygiene according to Loe and Silness plaque index.
• Primary molars with deep carious lesion, that are indicated for pulpotomy and crown.
• Primary molars having two-thirds of root structure left radiographically
• Parents' willingness to participate through informed written consent

You may not qualify if:

• Children with oral parafunctional habits.
• Primary molars with bifurcation involvement
• Presence of abscess or fistula related to the selected tooth
• Primary molars with insufficient crown structure

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

outpatient clinic of pediatric dentistry -faculty of dentistry- Alexandria university

Alexandria, Azarita, Egypt

Location

Related Publications (6)

• Taran PK, Kaya MS. A Comparison of Periodontal Health in Primary Molars Restored with Prefabricated Stainless Steel and Zirconia Crowns. Pediatr Dent. 2018 Sep 15;40(5):334-339.

  PMID: 30355428 BACKGROUND

• Clark L, Wells MH, Harris EF, Lou J. Comparison of Amount of Primary Tooth Reduction Required for Anterior and Posterior Zirconia and Stainless Steel Crowns. Pediatr Dent. 2016 Jan-Feb;38(1):42-6.

  PMID: 26892214 BACKGROUND

• Salman N, Khattab N, Gomaa Y, Elheeny A. Parental satisfaction regarding two types of commercial crowns for restoring pulpotomized primary molars. Egypt Dent J . 2021;67:2915-21.

  BACKGROUND

• Sai Sarath K, Murali G, Elangovan A, Kalaivanan D. Case series on personalized pediatric posterior Zirconia crowns: Case report. Int J Pedod Rehabil . 2022;7:46-50.

  BACKGROUND

• Mittal GK, Verma A, Pahuja H, Agarwal S, Tomar H. Esthetic crowns in pediatric dentistry: A review. Int J Contemporary Medical Res. 2016;3:1280-2.

  BACKGROUND

• Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.

  PMID: 27306242 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: February 10, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)