Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758221
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2021-02-12
Brief Title:
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors 3 Years Results
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors Prospective Single Arm Study
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Prospective single arm study was to evaluate the clinical success and or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months
Design Forty two primary incisors out of 14 children aged 2-5years treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6 12 18 24 and 36 months included in the study The parameters recorded at the baseline and at the follow-up intervals were retention colour match the number and location of the decayed surfaces recurrent caries chipping fracture of the restoration and loss of restoration failure
Materials and Methods A total of 14 pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study A total of 42 decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth The patients returned at the end of 6 12 18 24 and 36 months and received clinical examinations Another dentist co-author who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service USPHS criteria
Design Forty two primary incisors out of 14 children aged 2-5years treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6 12 18 24 and 36 months included in the study The parameters recorded at the baseline and at the follow-up intervals were retention colour match the number and location of the decayed surfaces recurrent caries chipping fracture of the restoration and loss of restoration failure
Materials and Methods A total of 14 pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study A total of 42 decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth The patients returned at the end of 6 12 18 24 and 36 months and received clinical examinations Another dentist co-author who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service USPHS criteria
Detailed Description:
Purpose The purpose of this study was to evaluate the clinical success and or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months
Design Forty two primary incisors out of 14 children aged 2-5years treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6 12 18 24 and 36 months included in the study The parameters recorded at the baseline and at the follow-up intervals were retention colour match the number and location of the decayed surfaces recurrent caries chipping fracture of the restoration and loss of restoration failure
Materials and Methods A total of 14 pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study A total of 42 decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth The patients returned at the end of 6 12 18 24 and 36 months and received clinical examinations Another dentist co-author who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service USPHS criteria The USPHS system is primarily for posterior teeth so a new system was developed for anterior teeth The definitions and criteria for the rating system are detailed in Table 1 Briefly it was a photographic examination including an evaluation of the color shape and integrity of the strip crown
All patients were recalled and restorations were evaluated for anatomic form surface texture recurrent caries color match and retention in accordance with Ryges Direct US Public Health Service evaluation criteria at baseline immediately postoperative and intervals of 6 12 24 and 36 months
The crown was considered to be clinically successful if the surface appeared smooth the colour remained good or acceptable without chipping fracture or recurrent caries at toothrestoration interface and there is no loss of the restoration
Data are analyzed using percentages frequencies and cumulative frequencies The Z-test will be used for comparison between failure rates of the two types of failures Failure due to trauma failure of bonding significance level is set at P 005 The Chi squared test will be used for association between the number of affected surfaces and the total failures The level of significance P-value is set at P 005
Design Forty two primary incisors out of 14 children aged 2-5years treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6 12 18 24 and 36 months included in the study The parameters recorded at the baseline and at the follow-up intervals were retention colour match the number and location of the decayed surfaces recurrent caries chipping fracture of the restoration and loss of restoration failure
Materials and Methods A total of 14 pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study A total of 42 decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth The patients returned at the end of 6 12 18 24 and 36 months and received clinical examinations Another dentist co-author who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service USPHS criteria The USPHS system is primarily for posterior teeth so a new system was developed for anterior teeth The definitions and criteria for the rating system are detailed in Table 1 Briefly it was a photographic examination including an evaluation of the color shape and integrity of the strip crown
All patients were recalled and restorations were evaluated for anatomic form surface texture recurrent caries color match and retention in accordance with Ryges Direct US Public Health Service evaluation criteria at baseline immediately postoperative and intervals of 6 12 24 and 36 months
The crown was considered to be clinically successful if the surface appeared smooth the colour remained good or acceptable without chipping fracture or recurrent caries at toothrestoration interface and there is no loss of the restoration
Data are analyzed using percentages frequencies and cumulative frequencies The Z-test will be used for comparison between failure rates of the two types of failures Failure due to trauma failure of bonding significance level is set at P 005 The Chi squared test will be used for association between the number of affected surfaces and the total failures The level of significance P-value is set at P 005
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