Assessment of Novaloc and Locator Attachment Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-05

Study Completion Date

2024-12-05

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.

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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

Conditions

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Completely Edentulous Maxilla

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups

Study Groups

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Novaloc attachment

a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.

Group Type EXPERIMENTAL

Novaloc attachment

Intervention Type DEVICE

Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment

locator attachment

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

Group Type ACTIVE_COMPARATOR

Locator attachment

Intervention Type DEVICE

Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment

Interventions

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Novaloc attachment

Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment

Intervention Type DEVICE

Locator attachment

Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment

Intervention Type DEVICE

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes