Assessment of Novaloc and Locator Attachment Systems

Study Overview
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Brief Summary
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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
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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

Official Title
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Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study

Conditions
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Completely Edentulous Maxilla

Intervention / Treatment
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* Device: Novaloc attachment
* Device: Locator attachment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novaloc attachment<br>a newly developed device novaloc attachment systemmade of peek material and amorphous diamond like carbon. | Device: Novaloc attachment<br>* Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment<br>|
| Active Comparator: locator attachment<br>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 | Device: Locator attachment<br>* Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Through study completion an average 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implant overdenture, maxilla, novaloc, locator, peek