Assessment of Novaloc and Locator Attachment Systems

NCT06011031 | Unknown

• 1 other identifier: FDASU- Rec ID 032117
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Completely Edentulous Maxilla

Keywords

implant overdenture; maxilla; novaloc; locator; peek

Outcome Measures

Primary Outcomes (1)

• bone level change around implants

  measurement of bone height mesial, distal to each implant

  Through study completion an average 1 year.

Secondary Outcomes (1)

• patient satisfaction

  Through study completion an average 1 year.

Study Arms (2)

Novaloc attachment

EXPERIMENTAL

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

Device: Novaloc attachment

locator attachment

ACTIVE COMPARATOR

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

Interventions

Novaloc attachment DEVICE

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

Novaloc attachment

Locator attachment DEVICE

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

locator attachment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Prosthodontics Department Faculty of Dentistry Ain Shams University

Cairo, 11591, Egypt

Location

Study Officials

• 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

  STUDY DIRECTOR

• Fatma Fouad Sadek, AssistantLec

  Egyptian Russian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 25, 2023
• Study Start: June 5, 2021
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year following publishing
• Access Criteria: researchers , students or post graduates

Locations

EG (1)