Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599450
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Single vs Two Implants for Mandibular Overdentures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures
Status:
COMPLETED
Status Verified Date:
2024-09
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:
SIMOTIMO
Brief Summary:
This study aimed to compare the use of single implants in the symphyseal and parasymphyseal and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation marginal bone loss and masticatory efficiency The null hypothesis was that there was no statistically significant difference in clinical evaluation marginal bone loss and masticatory efficiency among single symphyseal implants single parasymphyseal implants and two-implant-assisted complete mandibular overdentures
Detailed Description:
This randomized controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures Fifteen completely edentulous male patients 50-65 years were chosen and randomly grouped into three equal groups five patients in each according to the position and number of the received implants to assist mandibular complete overdentures Group I single median implant Group II single parasymphyseal implant Group III two implants were inserted in the canine area bilaterally After three months of osseointegration the lower denture was transformed into an implant-assisted complete mandibular overdenture Clinical observations were documented on the day of loading three six and nine months later for each implant Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading six and twelve months later The masticatory efficiency evaluation was conducted one month and three months after loading
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