Badly Decayed Primary Molars, Preformed Pediatric Posterior Crowns
Conditions
Keywords
bioflex crown, zerconia crown, stainless steel crown, clinical success
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.
Interventions
OTHERbioflex 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.
OTHERzerconia 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
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
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Data analyst
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gingival health | follow up at 3,6 and 9 months | Evaluated using the gingival index, with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plaque accumulation | 3,6 and 9 months | 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. |
| crown retention | 3,6 and 9 months | 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 |
| marginal integrity | 3,6 and 9 months | 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 |
| color change | 3,6 and 9 months | 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 |
| surface roughness | 3,6 and 9 months | 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 |
| parental satisfaction | 3,6 and 9 months | 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). |
| child post-operative discomfort | immediately post-operative and 48 hours post-operative | 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. |
Countries
Egypt
Outcome results
None listed