Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Brief Title:
Time and Cost-implications of Intraoral Scans vs Alginate Impressions A Randomised Controlled Trial
Sponsor:
University of Sheffield
Organization:
University of Sheffield
Study Overview
Official Title:
Time and Cost-implications of Intraoral Scans vs Alginate Impressions A Randomised Controlled 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:
This research project investigates the time and cost implications of two common techniques in orthodontics alginate impressions and intraoral scans Alginate impressions putty moulds are a traditional technique that has been used in orthodontic practice for many years Intraoral scans are a more modern method and are becoming more commonly used in orthodontic practice Both alginate impressions and intraoral scans are a means of recording a copy of a patients teeth which aids in record keeping and treatment planning
Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning it remains common practice to use alginate impressions for orthodontic records Considerations such as time implications device costs associated software expenses and the need for clinician training pose challenges to widespread adoption of intraoral scanning When comparing chairside time taken for intraoral scans versus alginate impressions there are varying findings requiring a thorough investigation
The main question being addressed is
- Are intraoral scans more time efficient than alginate impressions
The secondary question being addressed is
- Are intraoral scans more cost effective than alginate impressions
This research protocol outlines a clinical trial evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital
The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings thereby informing clinical practices within the United Kingdom This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care
Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning it remains common practice to use alginate impressions for orthodontic records Considerations such as time implications device costs associated software expenses and the need for clinician training pose challenges to widespread adoption of intraoral scanning When comparing chairside time taken for intraoral scans versus alginate impressions there are varying findings requiring a thorough investigation
The main question being addressed is
- Are intraoral scans more time efficient than alginate impressions
The secondary question being addressed is
- Are intraoral scans more cost effective than alginate impressions
This research protocol outlines a clinical trial evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital
The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings thereby informing clinical practices within the United Kingdom This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care
Detailed Description:
Over the years there has been a significant evolution in orthodontic treatment with recent technological advancements playing a pivotal role While traditional alginate impressions have been a mainstay for many years the advent of intraoral scanning in recent years represents a transformative shift in orthodontic practices Intraoral scanners have been designed to capture direct optical impressions offering potential advantages such as enhanced patient experience increased efficiency improved accuracy real-time visualisation rapid data transfer and reduced requirement for physical storage space Christopoulou et al 2022 Sivaramakrishnan et al 2020 However it is crucial to acknowledge certain limitations that impede their widespread adoption in orthodontics Considerations such as the devices cost associated software expenses and the necessity for clinician training for its utilisation must be weighed Christopoulou et al 2022
An extensive review of the literature has unveiled numerous studies investigating orthodontic patient experience by comparing traditional impression techniques with intraoral scans In an earlier study conducted by Grünheid et al 2014 733 of patients exhibited a preference for alginate impressions citing reasons such as perceived speed and simplicity Burhardt et al 2016 made contradictory conclusions stating orthodontic patients experienced higher levels of queasiness and discomfort during alginate impressions in comparison to intraoral scans with 51 of patients favouring the latter This finding was confirmed in studies by Mangano et al 2018 and Luqmani et al 2020 where 100 and 91 of orthodontic patients respectively expressed a clear preference for intraoral scanning Additionally a 2020 systematic review and meta-analysis of 11 studies involving 471 patients revealed the number of patients favouring intraoral scans was statistically significant Sivaramakrishnan et al 2020
With regards to chairside time taken for alginate impressions and intraoral scans there is conflicting evidence Research conducted by Luqmani et al 2020 and Burzynski et al 2018 revealed a significant statistical difference in mean chairside time indicating traditional impressions required less time than intraoral scans These findings were consistent with the outcomes in the meta-analysis by Sivaramakrishnan et al 2020 It was also noted that the time taken for the digital impression varied dependent on manufacturer Sivaramakrishnan et al 2020 These observations contrast with those displayed in a study by Bosoni et al 2023 which reported a significantly shorter scanning time compared to alginate impression time P001 Adding to the complexity studies by Glisic et al 2019 and Yilmaz and Aydin 2019 found no statistically significant difference in chairside time when comparing the two techniques These divergent findings highlight the need for an improved understanding of chairside time considerations in the context of orthodontic procedures
The economic viability of incorporating specific techniques into orthodontic practice is an important consideration In the study by Glisic et al 2019 the initial cost of the digital procedure was calculated to be 107 times higher than the traditional production of plaster models However after a span of 36 years the two procedures were found to be equivalent in terms of cost Glisic et al 2019 In a comprehensive literature review conducted by Mangano et al 2017 direct savings were identified through the elimination of conventional impression materials and increased efficiency Nevertheless an essential aspect to take into account is the additional costs associated with software upgrades Mangano et al 2017 Notably there is limited evidence comparing the cost implications of alginate impressions versus intraoral scans in orthodontics
Patient-centred care lies at the forefront of research with patient experience being an essential factor in the integration of innovative techniques Robust evidence overwhelmingly supports the patients preference towards intraoral scans as opposed to alginate impressions While reported drawbacks of intraoral scans include chairside time and associated costs the existing evidence of these aspects presents a conflicting and limited picture necessitating further exploration Additionally there is a noticeable scarcity of evidence regarding chairside time and costs specific to each technique in orthodontic patients in the United Kingdom
This research protocol outlines a randomised controlled trial designed to evaluate the chairside time and costs associated with intraoral scanning versus alginate impressions The results of this study will provide valuable insights into the time and cost ramifications of both techniques thereby aiding and informing clinical practices and technological assimilation within orthodontic settings in the United Kingdom Consequently these contributions will strengthen the existing evidence base in the field
2 Summary This research project investigates the evolving landscape of orthodontic practices by comparing the time and cost implications of two prevalent techniques intraoral scanning and traditional alginate impressions
Whilst the majority of the existing literature reveals patient preference in favour of intraoral scanning it remains common practice to use alginate impressions for orthodontic records Considerations such as time implications device costs associated software expenses and the need for clinician training pose challenges to widespread adoption of intraoral scanning When comparing chairside time taken for intraoral scans versus alginate impressions there are inconsistent findings necessitating a comprehensive investigation
This research protocol describes a prospective single-centre parallel-arm randomised controlled trial with a 11 allocation evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital
The outcomes of this study will provide crucial insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings thereby informing clinical practices and facilitating technological assimilation within the United Kingdom This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care
An extensive review of the literature has unveiled numerous studies investigating orthodontic patient experience by comparing traditional impression techniques with intraoral scans In an earlier study conducted by Grünheid et al 2014 733 of patients exhibited a preference for alginate impressions citing reasons such as perceived speed and simplicity Burhardt et al 2016 made contradictory conclusions stating orthodontic patients experienced higher levels of queasiness and discomfort during alginate impressions in comparison to intraoral scans with 51 of patients favouring the latter This finding was confirmed in studies by Mangano et al 2018 and Luqmani et al 2020 where 100 and 91 of orthodontic patients respectively expressed a clear preference for intraoral scanning Additionally a 2020 systematic review and meta-analysis of 11 studies involving 471 patients revealed the number of patients favouring intraoral scans was statistically significant Sivaramakrishnan et al 2020
With regards to chairside time taken for alginate impressions and intraoral scans there is conflicting evidence Research conducted by Luqmani et al 2020 and Burzynski et al 2018 revealed a significant statistical difference in mean chairside time indicating traditional impressions required less time than intraoral scans These findings were consistent with the outcomes in the meta-analysis by Sivaramakrishnan et al 2020 It was also noted that the time taken for the digital impression varied dependent on manufacturer Sivaramakrishnan et al 2020 These observations contrast with those displayed in a study by Bosoni et al 2023 which reported a significantly shorter scanning time compared to alginate impression time P001 Adding to the complexity studies by Glisic et al 2019 and Yilmaz and Aydin 2019 found no statistically significant difference in chairside time when comparing the two techniques These divergent findings highlight the need for an improved understanding of chairside time considerations in the context of orthodontic procedures
The economic viability of incorporating specific techniques into orthodontic practice is an important consideration In the study by Glisic et al 2019 the initial cost of the digital procedure was calculated to be 107 times higher than the traditional production of plaster models However after a span of 36 years the two procedures were found to be equivalent in terms of cost Glisic et al 2019 In a comprehensive literature review conducted by Mangano et al 2017 direct savings were identified through the elimination of conventional impression materials and increased efficiency Nevertheless an essential aspect to take into account is the additional costs associated with software upgrades Mangano et al 2017 Notably there is limited evidence comparing the cost implications of alginate impressions versus intraoral scans in orthodontics
Patient-centred care lies at the forefront of research with patient experience being an essential factor in the integration of innovative techniques Robust evidence overwhelmingly supports the patients preference towards intraoral scans as opposed to alginate impressions While reported drawbacks of intraoral scans include chairside time and associated costs the existing evidence of these aspects presents a conflicting and limited picture necessitating further exploration Additionally there is a noticeable scarcity of evidence regarding chairside time and costs specific to each technique in orthodontic patients in the United Kingdom
This research protocol outlines a randomised controlled trial designed to evaluate the chairside time and costs associated with intraoral scanning versus alginate impressions The results of this study will provide valuable insights into the time and cost ramifications of both techniques thereby aiding and informing clinical practices and technological assimilation within orthodontic settings in the United Kingdom Consequently these contributions will strengthen the existing evidence base in the field
2 Summary This research project investigates the evolving landscape of orthodontic practices by comparing the time and cost implications of two prevalent techniques intraoral scanning and traditional alginate impressions
Whilst the majority of the existing literature reveals patient preference in favour of intraoral scanning it remains common practice to use alginate impressions for orthodontic records Considerations such as time implications device costs associated software expenses and the need for clinician training pose challenges to widespread adoption of intraoral scanning When comparing chairside time taken for intraoral scans versus alginate impressions there are inconsistent findings necessitating a comprehensive investigation
This research protocol describes a prospective single-centre parallel-arm randomised controlled trial with a 11 allocation evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital
The outcomes of this study will provide crucial insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings thereby informing clinical practices and facilitating technological assimilation within the United Kingdom This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care
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