Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652217
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
splint
Brief Summary:
Each eligible patient will be randomly into one of two groups
Group A The digital splint group digital splint will be constructed to each patient
Group B The conventional splint group conventional splint will be constructed to each patient
For both groups thorough clinical examination scaling and root-planning will be done Patient will receive a motivational oral hygiene program with detailed explanation regarding the study process and outcome expectations
A precise history and clinical examination will be done by FM under supervision of Dr SG
The digital splint construction method
First complete arch intraoral digital scans of the maxillary and mandibular arches will be performed using the intra oral scanner following the scanning protocol recommended by the manufacturer
For inter maxillary relation recording using optical jaw tracking device step-by-step procedure for tracking and recording the maxillomandibular relationship and mandibular motion by using an optical jaw tracking system will be illustrated to the patient
The occlusal device will be designed using a CAD software program
The occlusal device will be printed using a 3D printer
The occlusal device will be finished and polished manually
The conventional splint construction method
The first step is making an impression using a quick-setting addition polyvinyl siloxane impression material A stone model will be obtained after pouring the impression using extra-hard dental stone
In the second visit a face bow transfer and a centric relation record will be utilized to mount the casts on a semi adjustable articulator
For centric relation recording a jig will be made with an incisal plateau from modeling plastic impression compound and the jig will be inserted between the central incisors To measure centric relation as precisely as possible by avoiding translational movement in the temporomandibular joint
The jig will be adjusted with a scalpel to create a distance of no more than 2 mm between the maxillary and mandibular arches Then the relation will be recorded using a fast-setting polyvinyl siloxane occlusal registration material The occlusal registrations will be trimmed to the buccal cusp tips to be transferred accurately to the articulator without interference
After mounting of the centric relation the protrusive record will be taken and the horizontal condylar angle will be adjusted accordingly
The device will be fabricated from clear prosthetic resin Production followed a standardized protocol with a minimum inter maxillary thickness of 15 mm and a buccal extension to 1 mm below the survey line
The device will be finished and occlusion will be adjusted on the articulator outcomes assessment
1 Occlusal force distribution will be measured using osslusosense
2 Cost effectiveness will be assessed using the following equationCE ratio CE
Group A The digital splint group digital splint will be constructed to each patient
Group B The conventional splint group conventional splint will be constructed to each patient
For both groups thorough clinical examination scaling and root-planning will be done Patient will receive a motivational oral hygiene program with detailed explanation regarding the study process and outcome expectations
A precise history and clinical examination will be done by FM under supervision of Dr SG
The digital splint construction method
First complete arch intraoral digital scans of the maxillary and mandibular arches will be performed using the intra oral scanner following the scanning protocol recommended by the manufacturer
For inter maxillary relation recording using optical jaw tracking device step-by-step procedure for tracking and recording the maxillomandibular relationship and mandibular motion by using an optical jaw tracking system will be illustrated to the patient
The occlusal device will be designed using a CAD software program
The occlusal device will be printed using a 3D printer
The occlusal device will be finished and polished manually
The conventional splint construction method
The first step is making an impression using a quick-setting addition polyvinyl siloxane impression material A stone model will be obtained after pouring the impression using extra-hard dental stone
In the second visit a face bow transfer and a centric relation record will be utilized to mount the casts on a semi adjustable articulator
For centric relation recording a jig will be made with an incisal plateau from modeling plastic impression compound and the jig will be inserted between the central incisors To measure centric relation as precisely as possible by avoiding translational movement in the temporomandibular joint
The jig will be adjusted with a scalpel to create a distance of no more than 2 mm between the maxillary and mandibular arches Then the relation will be recorded using a fast-setting polyvinyl siloxane occlusal registration material The occlusal registrations will be trimmed to the buccal cusp tips to be transferred accurately to the articulator without interference
After mounting of the centric relation the protrusive record will be taken and the horizontal condylar angle will be adjusted accordingly
The device will be fabricated from clear prosthetic resin Production followed a standardized protocol with a minimum inter maxillary thickness of 15 mm and a buccal extension to 1 mm below the survey line
The device will be finished and occlusion will be adjusted on the articulator outcomes assessment
1 Occlusal force distribution will be measured using osslusosense
2 Cost effectiveness will be assessed using the following equationCE ratio CE
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None