Clinical Trials Directory

Trials / Completed

CompletedNCT04708132

Maintenance and Tissues Conditions of Fixed Screw-Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures

Prosthetic Maintenance and Peri- Implant Tissues Conditions of Fixed Screw- Retained Implant Prosthesis Versus Implant-Retained Ball Overdentures: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Kafrelsheikh University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREScrew retained restorationHybrid prosthesis
PROCEDUREimplant-retained ball overdenturesRemovable prosthesis

Timeline

Start date
2019-01-01
Primary completion
2020-11-01
Completion
2020-11-01
First posted
2021-01-13
Last updated
2021-01-13

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04708132. Inclusion in this directory is not an endorsement.