Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228859
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-12-16
Brief Title:
Evaluation of Locator Versus TITACH Attachment for Mandibular Overdentures
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Evaluation of Locator Versus TITACH Attachment for Mandibular 2-Implant Overdentures One-year Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
The purpose of this randomized controlled clinical study was to evaluate the locator and TITACH attachments used for retaining mandibular 2-implant overdentures regarding retention bite force and implant marginal bone loss after overdenture insertion
Detailed Description:
Locator resilient stud attachments have grown in favor in recent decades because they are self-aligned give dual retention and need less inter-arch space The attachments low profile may be beneficial in individuals with limited restorative space for reducing denture breakage Furthermore the interchangeable color-coded nylon inserts come in a variety of retention levels Furthermore the attachments allow for limited hinge movement and may adjust implant inclination of up to 40 degrees However nylon inserts exhibit significant wear and distortion and need intensive care Elsyad et al discovered that Locator attachments had the greatest incidence of prosthetic problems particularly weardistortion and replacement of retentive components in a recent 5-year randomized controlled experiment
A current study TITACH attachment Implanova Dental Implants Dental Evolutions Inc USA was designed to alleviate the issues associated with Locator attachments Unlike the Locator systems nylon attachments this connection enables metal-to-metal contact between the abutment and its cap TITACH abutment TITACH metal cap and a silicone sleeve are the three components When the metal cap engages the abutment vertical holes allow it to open The silicone sleeve functions as a block-out during cap pick-up This type of connection may accommodate up to 33o divergence for a single implant or 66o divergence for contralateral implants A vertical clearance of 45 mm and a diameter of 6 mm are required to fit the cap It enables up to 02 mm of vertical cushioning allowing for mucosal compression during function and progressive prosthesis seating Furthermore each attachment can withstand 7-10 lbs of force
Retention is the power of a dental prosthesis to withstand pressures of dislodgment along the line of installation Prosthesis retention has been established as one of the most essential aspects in achieving successful implant overdenture therapy and increased patient satisfactionIn a previous in-vitro study TITACH attachments were related to better retentive force results than Locator attachments according to the authors Although in-vitro retention testing provides for the standardization of testing conditions Oral conditions such as mucosa saliva temperature and masticatory stress may affect retention values24 Because intraoral parameters such as the presence of saliva and the structure of the residual ridge have been taken to be considered objective assessment of clinical retention forces is preferable to subjective evaluation Maximum biting force is determined by the activity of the jaws elevator muscles which is regulated by Cranio-mandibular biomechanics In individuals with ridge resorption dental implants will enhance biting force as part of masticatory efficiency Mandibular implant-supported overdentures have at least double the masticatory biting force of conventional dentures
Marginal bone loss MBL is a multifactorial occurrence that occurs around the cervical region of dental implants Monitoring MBL surrounding implants is critical for determining dental implant success because it is thought to be a reliable predictor of bone response to surgery and occlusal loading Whatever causes it marginal bone loss is a major contributor to the development of peri-implantitis
A current study TITACH attachment Implanova Dental Implants Dental Evolutions Inc USA was designed to alleviate the issues associated with Locator attachments Unlike the Locator systems nylon attachments this connection enables metal-to-metal contact between the abutment and its cap TITACH abutment TITACH metal cap and a silicone sleeve are the three components When the metal cap engages the abutment vertical holes allow it to open The silicone sleeve functions as a block-out during cap pick-up This type of connection may accommodate up to 33o divergence for a single implant or 66o divergence for contralateral implants A vertical clearance of 45 mm and a diameter of 6 mm are required to fit the cap It enables up to 02 mm of vertical cushioning allowing for mucosal compression during function and progressive prosthesis seating Furthermore each attachment can withstand 7-10 lbs of force
Retention is the power of a dental prosthesis to withstand pressures of dislodgment along the line of installation Prosthesis retention has been established as one of the most essential aspects in achieving successful implant overdenture therapy and increased patient satisfactionIn a previous in-vitro study TITACH attachments were related to better retentive force results than Locator attachments according to the authors Although in-vitro retention testing provides for the standardization of testing conditions Oral conditions such as mucosa saliva temperature and masticatory stress may affect retention values24 Because intraoral parameters such as the presence of saliva and the structure of the residual ridge have been taken to be considered objective assessment of clinical retention forces is preferable to subjective evaluation Maximum biting force is determined by the activity of the jaws elevator muscles which is regulated by Cranio-mandibular biomechanics In individuals with ridge resorption dental implants will enhance biting force as part of masticatory efficiency Mandibular implant-supported overdentures have at least double the masticatory biting force of conventional dentures
Marginal bone loss MBL is a multifactorial occurrence that occurs around the cervical region of dental implants Monitoring MBL surrounding implants is critical for determining dental implant success because it is thought to be a reliable predictor of bone response to surgery and occlusal loading Whatever causes it marginal bone loss is a major contributor to the development of peri-implantitis
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