Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482060
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
In Vivo Comparison of Two Different Occlusal Splints in Bruxism
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Evaluation of Amount of Wear and Patient Satisfaction of Two Different Occlusal Splint Materials in Individuals With Bruxism
Status:
COMPLETED
Status Verified Date:
2024-06
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:
According to the international consensus bruxism is a masticatory muscle activity consisting of grinding and clenching while sleep or wakefullness The etiology of bruxism is multifactorial and phisical and psychological facts are some causes of this habit Bruxism is one of the main causes of tooth wear and temporomandibular joint diseases Muscle ensembles that occur in bruxist individuals can cause temporomandibular joint degenerations There is no definitive method recommended for the treatment of sleep bruxism The most important clinical intervention for sleep bruxism is to protect teeth reduce teeth grinding relieve facial and temporal pain and improve sleep quality
Stabilization splint is the gold standard in temporomandibular joint treatments The purpose of occlusal splint treatment is to improve the functions of tmj and masticatory muscles by creating a balanced stable occlusion to eliminate the associated pain to reduce the effects of occlusal interferences and parafunctional habits Conventional occlusal devices have been fabricated from different materials including polyethylene PVAc-PE auto- heat- and lightpolymerized acrylic resin However despite the interesting characteristics of these materials they are not considered optimal due to potential thermal discomfort bad taste residual monomers dimensional instability undesirable shape or color fracture susceptibility and skin or respiratory allergies of polymethyl mehacrylate PMMA resin in addition to the time-demanding manufacturing process New digital technologies based on computer-aided design and computer-aided manufacturing have enabled the use of digital workflow in the fabrication of occlusal devices or other intraoral prostheses such as complete dentures and interim fixed restorations by using subtractive milling or additive approaches Such devices are manufactured from prefabricated and standard materials such as polycarbonate polyetheretherketone PEEK and PMMA discs The whole workflow of digital occlusal splints enhances occlusal design and considerably simplifies and optimizes the traditional occlusal splint manufacturing process Furthermore digital occlusal splints have shown superior performance over traditional ones in terms of fit quantitative control time-saving speed and dimensional stability
The aim of this study is to evaluate the patient satisfaction and wear rates of occlusal splint materials that fabricated with conventional and CADCAM techniques
Stabilization splint is the gold standard in temporomandibular joint treatments The purpose of occlusal splint treatment is to improve the functions of tmj and masticatory muscles by creating a balanced stable occlusion to eliminate the associated pain to reduce the effects of occlusal interferences and parafunctional habits Conventional occlusal devices have been fabricated from different materials including polyethylene PVAc-PE auto- heat- and lightpolymerized acrylic resin However despite the interesting characteristics of these materials they are not considered optimal due to potential thermal discomfort bad taste residual monomers dimensional instability undesirable shape or color fracture susceptibility and skin or respiratory allergies of polymethyl mehacrylate PMMA resin in addition to the time-demanding manufacturing process New digital technologies based on computer-aided design and computer-aided manufacturing have enabled the use of digital workflow in the fabrication of occlusal devices or other intraoral prostheses such as complete dentures and interim fixed restorations by using subtractive milling or additive approaches Such devices are manufactured from prefabricated and standard materials such as polycarbonate polyetheretherketone PEEK and PMMA discs The whole workflow of digital occlusal splints enhances occlusal design and considerably simplifies and optimizes the traditional occlusal splint manufacturing process Furthermore digital occlusal splints have shown superior performance over traditional ones in terms of fit quantitative control time-saving speed and dimensional stability
The aim of this study is to evaluate the patient satisfaction and wear rates of occlusal splint materials that fabricated with conventional and CADCAM techniques
Detailed Description:
The patients who applied to Marmara University Faculty of Dentistry Department of Prosthodontics with complaints of teeth clenching and grinding were clinically and radiologically examined A questionarre is also applied to evaluate the sleep bruxism 30 individuals diagnosed with sleep bruxism were included in this study The individuals were informed about bruxism its effects and the application of a stabilization splint and were divided into two groups randomly Stabilization splint was applied to one group with digital and to other group with conventional impression and production method
In the conventional treatment group impressions were taken with alginate impression material then the occlusal splint was fabricated with hard vinyl resin material in the dental laboratory The splints were appllied o the upper jaw in accordance with the recomendations of Okeson Canine guidence was provided in lateral movements Autopolymerizing acrylic Imıcryl Turkey was used for the adjustment of the splint intraorally The individuals were asked to come for monthly recalls according to the routine treatment procedure and the pain values measured by visual analog scale VAS The occlusal surfaces of the stabilization splints were scanned before the usage of splint and after the three and six months usage The wear amounts were calculated by Geomagic Control Program for evaluation Patient satisfaction was evaluated with the questionarre at the beginning and final stage of the treatment
In the CADCAM treatment group intraoral digital impressions were taken with an intraoral camera 3Shape Trios 3Shape Dental Systems Copenhagen Denmark and the occlusal splints were fabricated with methacrylate resin material by digital three dimensional production The splints were delivered to the individuals Minimal occlusal adjustment was performed to obtain canine guidence The individuals were asked to come for monthly recalls according to the routine treatment procedure and the pain values measured by visual analog scale VAS The occlusal surfaces of the stabilization splints were scanned before the usage of splint and after the three and six months usage The wear amounts were calculated by Geomagic Control Program for evaluation Patient satisfaction was evaluated with the questionarre at the beginning and final stage of the treatment
In the conventional treatment group impressions were taken with alginate impression material then the occlusal splint was fabricated with hard vinyl resin material in the dental laboratory The splints were appllied o the upper jaw in accordance with the recomendations of Okeson Canine guidence was provided in lateral movements Autopolymerizing acrylic Imıcryl Turkey was used for the adjustment of the splint intraorally The individuals were asked to come for monthly recalls according to the routine treatment procedure and the pain values measured by visual analog scale VAS The occlusal surfaces of the stabilization splints were scanned before the usage of splint and after the three and six months usage The wear amounts were calculated by Geomagic Control Program for evaluation Patient satisfaction was evaluated with the questionarre at the beginning and final stage of the treatment
In the CADCAM treatment group intraoral digital impressions were taken with an intraoral camera 3Shape Trios 3Shape Dental Systems Copenhagen Denmark and the occlusal splints were fabricated with methacrylate resin material by digital three dimensional production The splints were delivered to the individuals Minimal occlusal adjustment was performed to obtain canine guidence The individuals were asked to come for monthly recalls according to the routine treatment procedure and the pain values measured by visual analog scale VAS The occlusal surfaces of the stabilization splints were scanned before the usage of splint and after the three and six months usage The wear amounts were calculated by Geomagic Control Program for evaluation Patient satisfaction was evaluated with the questionarre at the beginning and final stage of the treatment
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