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• The goal of this clinical trial is to evaluate the clinical effectiveness of bioflex crowns and zirconia crowns compared to stainless steel crowns when
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bioflex crown | Experimental |
| |
| zerconia crown | Experimental |
| |
| stainless steel crown | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| plaque accumulation | Measured using the plaque index was scored from 0 to 3 (0 = no plaque, 1=Soft debris covering not more than one third of the tooth surface, 2=Soft debris covering more than one third, but not more than two thirds, 3 =Soft debris covering more than two thirds of the tooth surface. | 3,6 and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| outpatient clinic of pediatric dentistry -faculty of dentistry- Alexandria university | Alexandria | Azarita | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30355428 | Background | 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. | |
| 26892214 | 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. |
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Data analyst
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|
| 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 |
|
| 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 |
|
| crown retention |
Assessed using the Modified United States Public Health Service Evaluation (USPHS) criteria, where "Alpha" = the crown is intact, "Bravo" = Crown is chipped (small but noticeable loss of material)but not enough to expose the underlying dentin/base, and "Charlie" = sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown |
| 3,6 and 9 months |
| marginal integrity | Assessed using the Modified United States Public Health Service Evaluation (USPHS) criteria , where "Alpha" indicates that the Crown is completely adapted to the tooth. No visible gap. No explorer catch at the margins, "Bravo" indicates Explorer catch, There is no visible evidence of a gap into which the explorer could penetrate, "Charlie" indicates Explorer penetrates into a deep gap that exposes dentin | 3,6 and 9 months |
| color change | Assessed using the Modified United States Public Health Service Evaluation (USPHS) criteria where: alpha =no change in color bravo= clinically acceptable, with staining that could be polished away charlie=clinically unacceptable, with heavy staining that could not be polished away | 3,6 and 9 months |
| surface roughness | Assessed using the Modified United States Public Health Service Evaluation (USPHS) criteria: Alpha= crown surface is smooth, Bravo= crown surface is slightly rough or has scratches, Charlie= Surface is deeply rough, with irregular scratches | 3,6 and 9 months |
| parental satisfaction | The questionnaire for assessing parental satisfaction includes four main categories for rating the following parameters whether the child's oral health, appearance and masticatory function were improved after placement of the crowns. Criteria evaluated in the survey will include also the parent's perception of the color and retention of each crown. Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied). | 3,6 and 9 months |
| child post-operative discomfort | Post-operative discomfort will be assessed Immediately after the dental procedure using a modified face pain scale, It consists of three schematic faces with different facial expressions for happy face (A) , indifferent face (B) and sad crying face (C) representing: A= Satisfaction B=Indifference C= Dissatisfaction each parent or guardian will be contacted via phone call after 48 hours to gather information about any sensitivity \ pain reported by the child. | immediately post-operative and 48 hours post-operative |
| 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. |
| 27306242 | 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. |