Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456879
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-05-19
Brief Title:
Clinical Performance and Convenience of Four Types of Crowns for Primary Molars
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Clinical Performance and Convenience of Three Types of Crowns as Esthetic Alternatives to Stainless Steel Crowns for Primary Molars
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars
The prefabricated commercially available zirconia crowns NuSmile NZC
The locally manufactured zirconia crowns created via Computer-Aided DesignComputer-Aided Manufacturing CADCAM system CCZC
The locally manufactured hybrid ceramic crowns created via Computer-Aided DesignComputer-Aided Manufacturing CADCAM system CCHC
The prefabricated commercially available zirconia crowns NuSmile NZC
The locally manufactured zirconia crowns created via Computer-Aided DesignComputer-Aided Manufacturing CADCAM system CCZC
The locally manufactured hybrid ceramic crowns created via Computer-Aided DesignComputer-Aided Manufacturing CADCAM system CCHC
Detailed Description:
Eighty lower second primary molars will be divided into 4 groups
Group 1n20 receive 3M ESPE Stainless Steel crowns for Primary Molars
Group 2 n20 receive the prefabricated commercially available zirconia crowns NuSmile NZC
Group 3 n20 receive the locally manufactured zirconia crowns created via CADCAM system CCZC
Group 4 n20 receive the locally manufactured hybrid ceramic crowns created via CADCAM system CCHC
Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria Oral health instructions will be given to the child and parents then the application of local anesthesia
1 Stainless steel crowns
Reduction of occlusal surface by about 15 mm using a flame shaped diamond bur to produce a uniform occlusal reduction Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation The crown should remain no more than 1 mm subgingivally21
2 Zirconia and hybrid ceramic crowns
The appropriate size of the posterior crown will be selected for the tooth chosen for treatment The occlusal surface will be reduced by 1-2 mm by using a flame bur after evaluation of the occlusal relationships The interproximal areas will be opened followed by reduction of the crown dimensions by 05-125 mm using a tapered diamond bur making the contour of the prepared tooth consistent with the natural contour The prepared tooth walls will be finished with a 1-2 mm subgingival feather-edge preparation using a thinner pointed tapered diamond bur
The selected crown will be tested for appropriate fit before the final cementation Finally the prepared tooth will be cleaned from saliva blood and the remnants of preparation and ready for cementation15 The selected crown will be cleaned and then filled with resin modified glass ionomer cement The crown will be applied with no resistance to the fully seated position on the tooth Passive Fit since forcing the crown to place can produce micro-fractures in the zirconia structure Excess cement will be removed using a dental probe and dental floss
Clinical evaluation
o Evaluation criteria concerning the clinical performance are
1 The Gingival Index GI22 will be measured by the William Gingival Probe with a blunt-ended instrument gently placed within the gingival gutter around each tooth to be crownedpreviously crowned and the values will be as follows 0 normal gingiva
1 mild inflammation a slight change in color slight edema no bleeding on probing
2 moderate inflammation redness edema and glazing or bleeding on probing
3 severe inflammation marked redness and edema a tendency toward spontaneous bleeding ulceration
2 Plaque Index PI22 will be measured by passing the gingival probe around each tooth to be crownedpreviously crowned and the values will be as follows 0 no plaque
1 film at the gingival margin and adjacent tooth 2 moderate accumulation of plaque 3 abundance of plaque
Crown retention 23 will be measured as follows
0 present
1 absent
Crown integrity24 will be measured as follows
0 intact
1 crack present
2 fracture present
3 crown lost
Marginal adaptation will be measured clinically and radiographically
1 All crowns will be evaluated clinically at baseline 3rd 6th 9th and 12th months and scored as follows25 0 Margin not discernible probe does not catch
1 Probe catches on margin but no gap on probing
2 Probe catches on margin and a gap on probing
3 Crown fractured or missing 2 All crowns will be evaluated radiographically at baseline 6th and 12th months to check the marginal adaptation
Color stability26 will be measured as follows
0 Unchanged
1 Minor deviation from original Wear of the antagonistic natural enamel To evaluate the wear of the antagonistic natural enamel of primary molar a rubber base impressions will be made immediately baseline and at 1 year after cementation The resulting casts will be scanned using a 3D scanner and 3D softare will be used to calculate the maximum amount of linear wear 27
o Evaluation criteria regarding the crown convenience Time elapsed since the start of tooth preparation till the crown cementation Anxiety using the Facial Image Scale FIS28 The Facial image scale comprises a row of five faces ranging from very happy to very unhappy The children were asked to point at which face they felt most like at that moment The scale is scored by giving a value of one to the most positive affect face and five to the most negative affect face Facial Image Scale has a fixed number of faces not a continuous line for the children to choose from thus making it easier to score in a clinical situation and easier for very young children to understand
Group 1n20 receive 3M ESPE Stainless Steel crowns for Primary Molars
Group 2 n20 receive the prefabricated commercially available zirconia crowns NuSmile NZC
Group 3 n20 receive the locally manufactured zirconia crowns created via CADCAM system CCZC
Group 4 n20 receive the locally manufactured hybrid ceramic crowns created via CADCAM system CCHC
Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria Oral health instructions will be given to the child and parents then the application of local anesthesia
1 Stainless steel crowns
Reduction of occlusal surface by about 15 mm using a flame shaped diamond bur to produce a uniform occlusal reduction Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation The crown should remain no more than 1 mm subgingivally21
2 Zirconia and hybrid ceramic crowns
The appropriate size of the posterior crown will be selected for the tooth chosen for treatment The occlusal surface will be reduced by 1-2 mm by using a flame bur after evaluation of the occlusal relationships The interproximal areas will be opened followed by reduction of the crown dimensions by 05-125 mm using a tapered diamond bur making the contour of the prepared tooth consistent with the natural contour The prepared tooth walls will be finished with a 1-2 mm subgingival feather-edge preparation using a thinner pointed tapered diamond bur
The selected crown will be tested for appropriate fit before the final cementation Finally the prepared tooth will be cleaned from saliva blood and the remnants of preparation and ready for cementation15 The selected crown will be cleaned and then filled with resin modified glass ionomer cement The crown will be applied with no resistance to the fully seated position on the tooth Passive Fit since forcing the crown to place can produce micro-fractures in the zirconia structure Excess cement will be removed using a dental probe and dental floss
Clinical evaluation
o Evaluation criteria concerning the clinical performance are
1 The Gingival Index GI22 will be measured by the William Gingival Probe with a blunt-ended instrument gently placed within the gingival gutter around each tooth to be crownedpreviously crowned and the values will be as follows 0 normal gingiva
1 mild inflammation a slight change in color slight edema no bleeding on probing
2 moderate inflammation redness edema and glazing or bleeding on probing
3 severe inflammation marked redness and edema a tendency toward spontaneous bleeding ulceration
2 Plaque Index PI22 will be measured by passing the gingival probe around each tooth to be crownedpreviously crowned and the values will be as follows 0 no plaque
1 film at the gingival margin and adjacent tooth 2 moderate accumulation of plaque 3 abundance of plaque
Crown retention 23 will be measured as follows
0 present
1 absent
Crown integrity24 will be measured as follows
0 intact
1 crack present
2 fracture present
3 crown lost
Marginal adaptation will be measured clinically and radiographically
1 All crowns will be evaluated clinically at baseline 3rd 6th 9th and 12th months and scored as follows25 0 Margin not discernible probe does not catch
1 Probe catches on margin but no gap on probing
2 Probe catches on margin and a gap on probing
3 Crown fractured or missing 2 All crowns will be evaluated radiographically at baseline 6th and 12th months to check the marginal adaptation
Color stability26 will be measured as follows
0 Unchanged
1 Minor deviation from original Wear of the antagonistic natural enamel To evaluate the wear of the antagonistic natural enamel of primary molar a rubber base impressions will be made immediately baseline and at 1 year after cementation The resulting casts will be scanned using a 3D scanner and 3D softare will be used to calculate the maximum amount of linear wear 27
o Evaluation criteria regarding the crown convenience Time elapsed since the start of tooth preparation till the crown cementation Anxiety using the Facial Image Scale FIS28 The Facial image scale comprises a row of five faces ranging from very happy to very unhappy The children were asked to point at which face they felt most like at that moment The scale is scored by giving a value of one to the most positive affect face and five to the most negative affect face Facial Image Scale has a fixed number of faces not a continuous line for the children to choose from thus making it easier to score in a clinical situation and easier for very young children to understand
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None