Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150768
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-21
Brief Title:
Porcelain-fused-to-metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Biting Force and Quality of Life in Porcelain-fused-to Metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II In Vivo Study
Status:
RECRUITING
Status Verified Date:
2023-11
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 goal of this randomized clinical trial is to compare biting force and patient satisfaction in three groups Patients in the control group number one will receive a CoCr removable partial denture and in the other two groups implants will be inserted to restore missed posterior teeth second mandibular premolar and second mandibular molar in the span area After three months implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two while in group number three implants will be loaded with three units of anatomical Zirconia-fixed partial dentures Biting force will be measured bilaterally at the time of delivery of the removable partial denture and delivery of fixed partial dentures after two four and six months Patient satisfaction will be assessed through a quality-of life questionnaire at the six-months recall appointment
Detailed Description:
Thirty-three partially edentulous patients will be recruited Patients will be randomly divided into three groups Patients in the control group number one will receive a CoCr removable partial denture in the other two groups implants will be inserted to restore missed posterior teeth second mandibular premolar and second mandibular molar in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent Pre-surgical and post-surgical prescription of antibiotics anti-inflammatory drugs analgesic drugs and mouthwash for one week then a follow-up will be done at the suture removal appointment After a three-month osseointegration period implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two while in group number three implants will be loaded with three units of anatomical Zirconia-fixed partial dentures Recall appointments will be scheduled for the patients two four and six months after loading for the collection of the data Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at the loading of implants after two four and six months Patient satisfaction will be assessed through a quality-of-life questionnaire at the six-months recall appointment
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