Assessment of Novaloc and Locator Attachment Systems

Ain Shams University14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Completely Edentulous Maxilla

Interventions

Novaloc attachmentDEVICE

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

Locator attachmentDEVICE

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Prosthodontics Department Faculty of Dentistry Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

bone level change around implants

measurement of bone height mesial, distal to each implant

Time frame: Through study completion an average 1 year.

Secondary Outcomes

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.

Time frame: Through study completion an average 1 year.

Data from ClinicalTrials.gov

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