Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 11:38 PM
Study NCT ID:
NCT04708132
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures
Sponsor:
Kafrelsheikh University
Organization:
Study Overview
Official Title:
Prosthetic Maintenance and Peri- Implant Tissues Conditions of Fixed Screw- Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-01
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 aim of this study was to compare the prosthetic maintenance requirements between implant-retained ball overdentures versus fixed screw- retained implant prosthesis. Clinical and radiographic changes in peri-implant tissue with using PGE2 as a PICF biomarker were also evaluated. Selected patients had been divided into two groups:
1. Group (I): twenty seven patients had received implant-Supported ball over dentures.
2. Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures
Surgical and prosthetic procedures:
Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.
The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.
Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.
Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.
• Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
1. Group (I): twenty seven patients had received implant-Supported ball over dentures.
2. Group (II): twenty-seven patients had received screw retained restorations Interventions and study procedures
Surgical and prosthetic procedures:
Surgical Procedures A radiopaque radiographic stent was formed and was positioned in the patient's mouth during cone beam scanning. Four implants were planned with two virtual replicas, in the place of the lateral incisor and the second premolar.
The stent was fabricated. After the healing period of four months finished, the patients were recalled and the super structure was fabricated according to the type of restoration Follow-up During the 12 months follow-up period, prosthodontic complications were recorded and calculated.
Postoperative care Along with a conventional oral hygiene assessment and functional checkup, follow up visits were scheduled every 6 months and up to 12 months total follow up period.
Clinical soft tissue measurements which include plaque index (PI), gingival index (GI), and PPD were measured at the mid-facial, mid-lingual, mid-mesial, and mid-distal aspects of each fixture using a graduated plastic probe to the nearest 0.5 mm. These clinical measurements were recorded after prosthesis delivery, 6 and 12 months postoperatively. The peri-implant marginal bone loss (MBL) was assessed radiographically after prosthesis delivery, 6 and 12 months postoperatively.
• Collection of peri-implant crevicular fluid (PICF) samples: PICF was collected.
Detailed Description:
None
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?: