Assessment of Novaloc and Locator Attachment Systems

January 31, 2024 updated by: Ain Shams University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Prosthodontics Department Faculty of Dentistry Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novaloc attachment
a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.
Device: Novaloc attachment
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment
Active Comparator: 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
Device: Locator attachment
Each patient will be restored with 4 implants retained maxillary overdenture with the assigned attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone level change around implants
Time Frame: Through study completion an average 1 year.
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
Time Frame: 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.
Through study completion an average 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: 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
  • Principal Investigator: Fatma Fouad Sadek, AssistantLec, Egyptian Russian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Estimated)

December 5, 2024

Study Completion (Estimated)

December 5, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU- Rec ID 032117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

once all data is collected, sharing of Study Protocol,Statistical Analysis Plan (SAP),Clinical Study Report (CSR) will be done

IPD Sharing Time Frame

1 year following publishing

IPD Sharing Access Criteria

researchers , students or post graduates

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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