Peri-Implantitis Clinical Trial
— ASPISRMSDOMFOfficial title:
All on Six Versus Parallel Implant Distribution for Screw Retained Maxillary Fixed Single Denture Opposing Mandibular All on Four Implant Distribution
NCT number | NCT05960500 |
Other study ID # | A05080622 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2022 |
Est. completion date | June 15, 2023 |
Verified date | July 2023 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to July2022 and 80% power was used to calculate patients sample according to the results of a previous study 1 which showed no significant difference was reported when comparing occlusal stability ,implant stability and periimplant soft tissue changes between different implants angulation of both groups. (Effect size=.70mm and α=.05). The power analysis was performed using the G*Power program (version 3.1.5, Kiel, Germany)
Status | Completed |
Enrollment | 30 |
Est. completion date | June 15, 2023 |
Est. primary completion date | May 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 55 Years to 65 Years |
Eligibility | Inclusion Criteria: - patient with maxillary edentulous alveolar ridges. - patient complained from insufficient retention and stability of their maxillary single denture. Exclusion Criteria: - medically compromised patients. - patients with parafunctional habits. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura university | Mansoura | Dakahlya |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | soft tissue changes around implants | The distance between marginal gingiva and the tip of the probe was measured using a calibrated plastic periodontal probe this distance is considered as pocket depth (PD).Probing depth was evaluated at buccal, lingual, mesial and distal aspect of each implant. using a calibrated pressure sensitive plastic periodontal probe. | 1 year | |
Secondary | occlusal stability | - Evaluation of the the concentration, changes of occlusion and visualization of the masticatory pressure conditions and amount of occlusal wear occured by Digital Occlusal Analyzer System (OccluSense) | 1 year | |
Secondary | implant stability | - Evaluation of the rate of Implant stability A range of PTVs (- 6 to +2) was considered for integrated implants that was measured by periotest device*. The hand piece was. held perpendicular to the long axis of the implants. | 1year |
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