Completely Edentulous Maxilla
Conditions
Keywords
implant overdenture, maxilla, novaloc, locator, peek
Brief summary
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.
Detailed description
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
Interventions
DEVICENovaloc attachment
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
DEVICELocator attachment
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Completely edentulous patient with u shaped dental arch. * Systemically free. * Patients completed all extraction at least 6 months before surgery. * Patients Tempromandibular joint is free from any disease. * Patient's mouth opening is proper for accessibility during surgery and implant placement. * Sufficient bone level (length, and width) at implant placement site. * Presence of enough bone height at implant site close to the maxillary sinus. * Absence of sinus pneumatization.
Exclusion criteria
* Heavy smoker. * Patients with bone diseases. * Patients having a history of parafunctional habits. * Patients with diabetes mellitus. * Patients on chemotherapy or radiotherapy. * Patients on any medications that reduce wound healing. * Patients without sufficient bone level (height, width). * Patients with sinus pneumatization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone level change around implants | Through study completion an average 1 year. | measurement of bone height mesial, distal to each implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | Through study completion an average 1 year. | 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. |
Countries
Egypt
Outcome results
None listed