Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial
NCT ID: NCT07156838
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-02-10
2025-11-30
Brief Summary
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* restoring primary molars 45 participant their age range between 6 and 8 years participated in this study. The participants are divided into three groups representing group (A) for Bioflx crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15).
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.
Also the periodontal health will be evaluated using gingival index and plaque index according to Silness and Loe. Moreover parental and child satisfaction
* will be evaluated
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bioflex crown
bioflex crown
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.
zerconia crown
zerconia crown
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
stainless steel crown
stainless steel crown
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
Interventions
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bioflex crown
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.
zerconia crown
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
stainless steel crown
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Primary molars with bifurcation involvement
* Presence of abscess or fistula related to the selected tooth
* Primary molars with insufficient crown structure
6 Years
8 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Asmaa Yahia
BDS
Locations
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outpatient clinic of pediatric dentistry -faculty of dentistry- Alexandria university
Alexandria, Azarita, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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1003-11/2024
Identifier Type: -
Identifier Source: org_study_id
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