Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-23
Brief Title:
Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children
Sponsor:
October University for Modern Sciences and Arts
Organization:
October University for Modern Sciences and Arts
Study Overview
Official Title:
Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
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:
Dental trauma DT of the incisors and their supporting tissues which is one of the most challenging dental emergency situations requires immediate assessment and management due to psychological and physical reasons 8 This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications The treatment of dental trauma is sometimes neglected 910 although it might lead to pain difficulty in articulation and mastication as well as having considerable negative effects on patients self-esteem 11 However aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings tooth color position alignment shape and number 12
Rasmussen ST et al discovered in 1981 that most children suffer from tooth trauma 13 According to their research 25 of all schoolchildren and 33 of adults have undergone trauma with the majority of cases occurring before the age of 19 14
As the maxillary incisors are the most commonly injured teeth due to their exposed position a functional aesthetic and time-efficient restoration is frequently demanded15 According to the current International Association of Dental Traumatology guidelines crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment16 As long as the fragment is intact reattachment is often preferred in dental practice This technique facilitates the restoration of the tooth with its original anatomy color and function in a minimum amount of time 1718 Unfortunately clinical studies regarding the survival of reattached fragments are scarce and results from laboratory investigations cannot be transferred to clinical settings without limitations 19 Furthermore longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies 20 21
In addition to the aforementioned restorative alternatives the use of small partial glassy restorations-partial laminate veneers PLVs sectional veneers or ceramic fragments-has become increasingly popular over the last few years 2223 PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth As tooth preparation is not required for this type of restoration as for conventional laminate veneers and minimal to no prep is accepted the maximum amount of enamel surface structure is conserved 24 Thus retention relies completely on adhesion which is primarily achieved by bonding to the conditioned glassy surface 2526 Despite their growing popularity available data in the literature on PLVs are limited to a few in vitro studies 2728 and case reports 29 30 31 without any clinical information available at present
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors either conventional composite restoration fragment reattachment or partial laminate veneers that require minimal to no preparation depends on the type of restoration will receive and doesnt require local anesthesia
Rasmussen ST et al discovered in 1981 that most children suffer from tooth trauma 13 According to their research 25 of all schoolchildren and 33 of adults have undergone trauma with the majority of cases occurring before the age of 19 14
As the maxillary incisors are the most commonly injured teeth due to their exposed position a functional aesthetic and time-efficient restoration is frequently demanded15 According to the current International Association of Dental Traumatology guidelines crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment16 As long as the fragment is intact reattachment is often preferred in dental practice This technique facilitates the restoration of the tooth with its original anatomy color and function in a minimum amount of time 1718 Unfortunately clinical studies regarding the survival of reattached fragments are scarce and results from laboratory investigations cannot be transferred to clinical settings without limitations 19 Furthermore longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies 20 21
In addition to the aforementioned restorative alternatives the use of small partial glassy restorations-partial laminate veneers PLVs sectional veneers or ceramic fragments-has become increasingly popular over the last few years 2223 PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth As tooth preparation is not required for this type of restoration as for conventional laminate veneers and minimal to no prep is accepted the maximum amount of enamel surface structure is conserved 24 Thus retention relies completely on adhesion which is primarily achieved by bonding to the conditioned glassy surface 2526 Despite their growing popularity available data in the literature on PLVs are limited to a few in vitro studies 2728 and case reports 29 30 31 without any clinical information available at present
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors either conventional composite restoration fragment reattachment or partial laminate veneers that require minimal to no preparation depends on the type of restoration will receive and doesnt require local anesthesia
Detailed Description:
Aim of the study
This randomized clinical trial study will assess the survival and success rates of three different types of conservative restorations restored the Ellis Class II traumatized central incisors by clinical evaluation of the patients
Research question
Are the direct resin composite mini-veneer reattachment of broken segments and IPS emax CAD clinically successful techniques in restoring Ellis Class II traumatized central incisors in children
PICOS
P Patients above 8 years old with traumatized upper incisor I 1 Partial laminate veneers PLV I 2 Fragment reattachment C Conventional composite restoration O Clinical Success S In-Vivo Study
II Methods
Study Design
Study Type Interventional Clinical Trial Estimated Enrolment 40 participants Allocation Randomized Intervention Model Parallel Assignment Primary Purpose Treatment Official Title Clinical Evaluation of Three Different Techniques restoring
Ellis Class II traumatized central incisors in children
Randomized Clinical Trial Estimated Study Start Date December 2023 Estimated Primary Completion Date January 2024
Trial design
The study is a randomized clinical trial RCT where 2 arm parallel groups with a 11 allocation ratio were compared The child participants and the legal guardian of each participating child and the statistician were blinded
Outcome Measures
1 Primary outcome Clinical success survival Time Frame 12 months
Clinical success will evaluate using a modified version of the United States Public Health Service USPHS criteria Appendix A
Each parameter will assess using visual and tactile observations probe and mirror
At the checkup visits 3 6 9 12 months will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician
The need for replacement and partial fractures chippings will define as failures
2 Secondary outcomes Time Frame 12 months
Marginal adaptation using Trios 3 scanner via scan compare microns
Colour change using Trios 3 scanner via scan compare yes or no binary
Patient centred outcomes to the restoration Patients satisfaction questioner 33 Appendix B Eligibility Criteria
Ages Eligible for Study 8 - 18 Years Sexes Eligible for Study All Accepts Healthy Volunteers Yes
Criteria
Inclusion Criteria
1 8-18 years old
2 Ellis Class II traumatized central incisors
3 Controlled dental disease - no active caries or periodontal diseases
4 Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria
1 All Ellis Classification traumatized central incisors except Ellis Class II
2 Patients with uncontrolled active tooth decay or periodontal disease ie 4 mm probing depth and bleeding on probing
3 Poor oral hygiene and motivation
4 Patients with parafunctional habits eg bruxism biting on hard objects
5 Patients with debilitating illnesses or complicating medical conditions
Explanation for choice of comparators
Composites resins have become the first choice for direct anterior and posterior restorations The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments Several studies have demonstrated that composite restorations may last long in clinical service Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1 to 3 in posterior teeth and 1 to 5 in anterior teeth 34
Thus direct resin composites offer several advantages to both patients and clinicians including a reduction in treatment costs and clinical working times ie fewer clinical appointments as well as reversibility and reparability of the treatment For these reasons most clinicians consider resin composites as the material of choice when maximum preservation of the tooth structure is required 2435
Sample size Power analysis
Sample size calculated depending on a previous study Oosterhaven et al 2023 as reference 24 According to this study the probability of color match clinical success in group 1 is 098 If the estimated probability of group 2 is 06 we will need to study 17 cases in each group with probability power 08 The Type I error probability Total sample size increased to 20 subjects per group to compensate for a 15 drop out during follow up Sample size calculation was achieved using chi-squared test to evaluate that was performed by using PS Power316 software Version 312 Vanderbilt University Nashville Tennessee USA
Statistical Methods
Statistical analysis
Data were collected tabulated and statistically analyzed using Microsoft Excel 2016 Statistical Package for Social Science SPSS Ver 24 And Minitab statistical software Ver 16
Handling of numerical quantitative variables
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests Data will be presented as mean amp standard deviation If data will be normally distributed comparison between 2 different groups will be performed by using independent t-test comparison between 2 related groups will be performed by using Paired t-test while comparison between more than 2 groups will be performed by using One Way ANOVA test followed by Tukeys Post Hoc test for multiple comparisons If data will be non-parametric data comparison between 2 different groups will be performed by using Mann-Whitney test comparison between 2 related groups will be performed by using Wilcoxon Signed Rank test while comparison between more than 2 groups will be performed by using Kruskal-Wallis test
Handling of categorial qualitative variables
Data will be presented as frequency and percentages All comparisons will be performed by using Chi square test
Recruitment
The study will be conducted at the pediatric dentistry department of MSA University pediatric outpatients All subjects will be monitored and reviewed every 3 months for 12 months
Post-trial care
Oral hygiene instructions and serving brush and toothpaste
Dietary recommendations
This randomized clinical trial study will assess the survival and success rates of three different types of conservative restorations restored the Ellis Class II traumatized central incisors by clinical evaluation of the patients
Research question
Are the direct resin composite mini-veneer reattachment of broken segments and IPS emax CAD clinically successful techniques in restoring Ellis Class II traumatized central incisors in children
PICOS
P Patients above 8 years old with traumatized upper incisor I 1 Partial laminate veneers PLV I 2 Fragment reattachment C Conventional composite restoration O Clinical Success S In-Vivo Study
II Methods
Study Design
Study Type Interventional Clinical Trial Estimated Enrolment 40 participants Allocation Randomized Intervention Model Parallel Assignment Primary Purpose Treatment Official Title Clinical Evaluation of Three Different Techniques restoring
Ellis Class II traumatized central incisors in children
Randomized Clinical Trial Estimated Study Start Date December 2023 Estimated Primary Completion Date January 2024
Trial design
The study is a randomized clinical trial RCT where 2 arm parallel groups with a 11 allocation ratio were compared The child participants and the legal guardian of each participating child and the statistician were blinded
Outcome Measures
1 Primary outcome Clinical success survival Time Frame 12 months
Clinical success will evaluate using a modified version of the United States Public Health Service USPHS criteria Appendix A
Each parameter will assess using visual and tactile observations probe and mirror
At the checkup visits 3 6 9 12 months will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician
The need for replacement and partial fractures chippings will define as failures
2 Secondary outcomes Time Frame 12 months
Marginal adaptation using Trios 3 scanner via scan compare microns
Colour change using Trios 3 scanner via scan compare yes or no binary
Patient centred outcomes to the restoration Patients satisfaction questioner 33 Appendix B Eligibility Criteria
Ages Eligible for Study 8 - 18 Years Sexes Eligible for Study All Accepts Healthy Volunteers Yes
Criteria
Inclusion Criteria
1 8-18 years old
2 Ellis Class II traumatized central incisors
3 Controlled dental disease - no active caries or periodontal diseases
4 Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria
1 All Ellis Classification traumatized central incisors except Ellis Class II
2 Patients with uncontrolled active tooth decay or periodontal disease ie 4 mm probing depth and bleeding on probing
3 Poor oral hygiene and motivation
4 Patients with parafunctional habits eg bruxism biting on hard objects
5 Patients with debilitating illnesses or complicating medical conditions
Explanation for choice of comparators
Composites resins have become the first choice for direct anterior and posterior restorations The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments Several studies have demonstrated that composite restorations may last long in clinical service Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1 to 3 in posterior teeth and 1 to 5 in anterior teeth 34
Thus direct resin composites offer several advantages to both patients and clinicians including a reduction in treatment costs and clinical working times ie fewer clinical appointments as well as reversibility and reparability of the treatment For these reasons most clinicians consider resin composites as the material of choice when maximum preservation of the tooth structure is required 2435
Sample size Power analysis
Sample size calculated depending on a previous study Oosterhaven et al 2023 as reference 24 According to this study the probability of color match clinical success in group 1 is 098 If the estimated probability of group 2 is 06 we will need to study 17 cases in each group with probability power 08 The Type I error probability Total sample size increased to 20 subjects per group to compensate for a 15 drop out during follow up Sample size calculation was achieved using chi-squared test to evaluate that was performed by using PS Power316 software Version 312 Vanderbilt University Nashville Tennessee USA
Statistical Methods
Statistical analysis
Data were collected tabulated and statistically analyzed using Microsoft Excel 2016 Statistical Package for Social Science SPSS Ver 24 And Minitab statistical software Ver 16
Handling of numerical quantitative variables
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests Data will be presented as mean amp standard deviation If data will be normally distributed comparison between 2 different groups will be performed by using independent t-test comparison between 2 related groups will be performed by using Paired t-test while comparison between more than 2 groups will be performed by using One Way ANOVA test followed by Tukeys Post Hoc test for multiple comparisons If data will be non-parametric data comparison between 2 different groups will be performed by using Mann-Whitney test comparison between 2 related groups will be performed by using Wilcoxon Signed Rank test while comparison between more than 2 groups will be performed by using Kruskal-Wallis test
Handling of categorial qualitative variables
Data will be presented as frequency and percentages All comparisons will be performed by using Chi square test
Recruitment
The study will be conducted at the pediatric dentistry department of MSA University pediatric outpatients All subjects will be monitored and reviewed every 3 months for 12 months
Post-trial care
Oral hygiene instructions and serving brush and toothpaste
Dietary recommendations
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