Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.
14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.
Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.
Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novaloc attachment | Experimental | a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon. |
|
| locator attachment | Active Comparator | a device with low-profile attachment used in cases of limited inter arch distance, provides excellent retention, possesses a self-aligning property and allow correction of implant divergence up to 20 degrees |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novaloc attachment | Device | Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone level change around implants | measurement of bone height mesial, distal to each implant | Through study completion an average 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hany Ibrahim Eid, Prof | Ain Shams University | Study Director |
| Noha Helmy Nawwar, Prof | Ain Shams University | Study Director |
| Ahmed Mohamed Osama, Prof | Ain Shams University | Study Director |
| Fatma Fouad Sadek, AssistantLec | Egyptian Russian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prosthodontics Department Faculty of Dentistry Ain Shams University | Cairo | 11591 | Egypt |
once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done
1 year following publishing
researchers , students or post graduates
Not provided
Not provided
This is a Randomized Clinical Trial (phase IV) as it will compare two types of attachment systems (a new one with an old one), assess the effects of both types, and state which one is better.
Not provided
Not provided
all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups
| Locator attachment | Device | Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment |
|
| Through study completion an average 1 year. |