Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797494
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2021-03-08
Brief Title:
Testing New Vertical Dimension Of Occlusion Prior To Restorative Treatment Of Tooth Wear
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
A Randomized Controlled Trial On Testing A New Vertical Dimension Of Occlusion Prior To Restorative Treatment Of Generalized Tooth Wear
Status:
COMPLETED
Status Verified Date:
2021-03
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 is a Randomized Controlled Trial RCT The aim of the study is to evaluate the necessity to test the desired increased Vertical Dimension of Occlusion VDO prior to restorative treatment of generalized tooth wear
Tooth wear is a physiological phenomenon that when becoming pathological can result in functional problems such as pain reduced quality of life and esthetic impairment Restorative treatment should be discussed with patients with severe or pathological tooth wear
The restorative treatment of generalized tooth wear includes restoration of teeth separately in increased VDO The increment of VDO is based upon clinical parameters such as the amount of natural tooth tissue the possibility to lengthen the anterior teeth in regard to an acceptable esthetics outcome and the Free Way Space FWS The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed
Traditionally it is believed that adapting to a new VDO results in clinical difficulties such as different speech pain of the Temporo Mandibular Joint TMJ masticatory muscle pain and increased masticatory muscles activity The latter could result in an increased bite force and possibly an increased failure rate of restorations Some operators then prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the restorative treatment
Patients with generalized severe tooth wear were included and restoratively treated with composite restorations Prior to restorative treatment patients were randomized to either receiving an acrylic Removable Appliance RA or no RA The RA was worn for 3 weeks prior to restorative treatment and included the intended increment of VDO These patients were asked to wear the RA during the whole day except when eating
After restorative treatment patients revisited our dental clinic after 1 month and after 1 year Quality of life was assessed with questionnaires FWS was assessed clinically Restorations were checked for clinical acceptability including small materials fractures
Tooth wear is a physiological phenomenon that when becoming pathological can result in functional problems such as pain reduced quality of life and esthetic impairment Restorative treatment should be discussed with patients with severe or pathological tooth wear
The restorative treatment of generalized tooth wear includes restoration of teeth separately in increased VDO The increment of VDO is based upon clinical parameters such as the amount of natural tooth tissue the possibility to lengthen the anterior teeth in regard to an acceptable esthetics outcome and the Free Way Space FWS The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed
Traditionally it is believed that adapting to a new VDO results in clinical difficulties such as different speech pain of the Temporo Mandibular Joint TMJ masticatory muscle pain and increased masticatory muscles activity The latter could result in an increased bite force and possibly an increased failure rate of restorations Some operators then prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the restorative treatment
Patients with generalized severe tooth wear were included and restoratively treated with composite restorations Prior to restorative treatment patients were randomized to either receiving an acrylic Removable Appliance RA or no RA The RA was worn for 3 weeks prior to restorative treatment and included the intended increment of VDO These patients were asked to wear the RA during the whole day except when eating
After restorative treatment patients revisited our dental clinic after 1 month and after 1 year Quality of life was assessed with questionnaires FWS was assessed clinically Restorations were checked for clinical acceptability including small materials fractures
Detailed Description:
This study is a Randomized Controlled Trial RCT The aim of the study is to evaluate the necessity to test the increased Vertical Dimension of Occlusion VDO prior to restorative treatment of generalized tooth wear
Tooth wear is a physiological phenomenon that when becoming pathological can result in functional problems such as pain reduced quality of life and esthetic impairment Restorative treatment should be discussed in with patients with severe or pathological tooth wear
The restorative treatment includes restoration of all teeth separately in increased VDO The increment of VDO is based upon clinical parameters as the amount of loss of natural tooth tissue the possibility to lengthen the maxillary anterior teeth in regard to an acceptable esthetic outcome and the Free Way Space FWS The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed
Traditionally it is believed that adapting to a new VDO results in clinical difficulties such as different speech pain of the Temporo Mandibular Joint TMJ masticatory muscle pain and increased masticatory muscles activity The latter could result in an increased bite force and an increased failure rate of restorations Some operators then prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the adaptation to the restorative treatment
The research was registered in the ClinicalTrialgov register after the study had been completed This RCT is part of RCT with a 2x2 design The first branch was used to randomize patients to certain restorative protocol which was enlisted in ClinicalTrialsgov NCT04326816 The second branch was designed to test the VDO prior to restorative treatment of generalized severe tooth wear Approval of the local Medical-Ethics-committee METC for the 2x2 RCT was sought and granted in 2010 Approval was granted to a protocol in which no Data Safety Monitoring Board was appointed as research standards were different in 2010 The study was conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act WMO
Sample size calculation base done by a biostatistician Calculations were completed based upon the first branch of the 2x2 RCT A group size of 75 patients was established Anonymized paper case report forms were completed at each moment and stored A separate digital database was made and used for data analysis Data analysis consisted of descriptive analysis of failed restorations and paired t-Test with a significance level of 5 Serious Adverse Events SAE report files and Suspected Unexpected Serious Adverse Reaction SUSAR report files were present and could be when necessary filled in and applied to the local METC
Patients were recruited as General Dental Practitioners GDP referred patients with generalized tooth wear to the academic clinic Patients were seen by 1 operator and were assessed for eligibility Patients received a written informed consent and were included if the informed consent was signed Patients received an identification number C1 to C49 A randomization was performed on the use of a removable appliance to test the VDO prior to restorative treatment Randomization with a block size of eight was performed The random sequence was put into envelopes The investigator opened the envelope in their numbered order and assigned the patient to the corresponding group immediately after the consent was acquired
A laboratory-made acrylic Removable Appliance RA was evaluated to test the adaptation of the patient to the increment of VDO In the control group no RA was prescribed prior to restorative treatment In the test group a RA was prescribed prior to restorative treatment Patients were asked to wear the RA for 24h per day with the exception for when eating during a period of 3 weeks Thereafter the acceptance was checked using a questionnaire
Data collection was done at predetermined moments ie baseline immediately after treatment 1 month after treatment 1 year after treatment During the recall moments Oral Health-related Quality of Life OHRQoL was assessed using questionnaires as was the FWS In addition restorations were checked based on clinical acceptability and all failures were recorded
No specific Quality assurance plan to address data validation and registry procedures including site monitoring and auditing was made prior to the onset of the study
Data checks were completed by 1 researcher Source data verification to assess the accuracy completeness and representativeness was completed by 1 researcher Medical records Electronic patient files digital photos made at recall appointments and paper case report forms were inspected No specific source data verification plan was made prior to the onset of the study
Tooth wear is a physiological phenomenon that when becoming pathological can result in functional problems such as pain reduced quality of life and esthetic impairment Restorative treatment should be discussed in with patients with severe or pathological tooth wear
The restorative treatment includes restoration of all teeth separately in increased VDO The increment of VDO is based upon clinical parameters as the amount of loss of natural tooth tissue the possibility to lengthen the maxillary anterior teeth in regard to an acceptable esthetic outcome and the Free Way Space FWS The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed
Traditionally it is believed that adapting to a new VDO results in clinical difficulties such as different speech pain of the Temporo Mandibular Joint TMJ masticatory muscle pain and increased masticatory muscles activity The latter could result in an increased bite force and an increased failure rate of restorations Some operators then prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the adaptation to the restorative treatment
The research was registered in the ClinicalTrialgov register after the study had been completed This RCT is part of RCT with a 2x2 design The first branch was used to randomize patients to certain restorative protocol which was enlisted in ClinicalTrialsgov NCT04326816 The second branch was designed to test the VDO prior to restorative treatment of generalized severe tooth wear Approval of the local Medical-Ethics-committee METC for the 2x2 RCT was sought and granted in 2010 Approval was granted to a protocol in which no Data Safety Monitoring Board was appointed as research standards were different in 2010 The study was conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act WMO
Sample size calculation base done by a biostatistician Calculations were completed based upon the first branch of the 2x2 RCT A group size of 75 patients was established Anonymized paper case report forms were completed at each moment and stored A separate digital database was made and used for data analysis Data analysis consisted of descriptive analysis of failed restorations and paired t-Test with a significance level of 5 Serious Adverse Events SAE report files and Suspected Unexpected Serious Adverse Reaction SUSAR report files were present and could be when necessary filled in and applied to the local METC
Patients were recruited as General Dental Practitioners GDP referred patients with generalized tooth wear to the academic clinic Patients were seen by 1 operator and were assessed for eligibility Patients received a written informed consent and were included if the informed consent was signed Patients received an identification number C1 to C49 A randomization was performed on the use of a removable appliance to test the VDO prior to restorative treatment Randomization with a block size of eight was performed The random sequence was put into envelopes The investigator opened the envelope in their numbered order and assigned the patient to the corresponding group immediately after the consent was acquired
A laboratory-made acrylic Removable Appliance RA was evaluated to test the adaptation of the patient to the increment of VDO In the control group no RA was prescribed prior to restorative treatment In the test group a RA was prescribed prior to restorative treatment Patients were asked to wear the RA for 24h per day with the exception for when eating during a period of 3 weeks Thereafter the acceptance was checked using a questionnaire
Data collection was done at predetermined moments ie baseline immediately after treatment 1 month after treatment 1 year after treatment During the recall moments Oral Health-related Quality of Life OHRQoL was assessed using questionnaires as was the FWS In addition restorations were checked based on clinical acceptability and all failures were recorded
No specific Quality assurance plan to address data validation and registry procedures including site monitoring and auditing was made prior to the onset of the study
Data checks were completed by 1 researcher Source data verification to assess the accuracy completeness and representativeness was completed by 1 researcher Medical records Electronic patient files digital photos made at recall appointments and paper case report forms were inspected No specific source data verification plan was made prior to the onset of the study
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