Assessment of Novaloc and Locator Attachment Systems

Not Applicable

Active, not recruiting

• Conditions: Completely Edentulous Maxilla
• Interventions: Device: Novaloc attachment; Device: Locator attachment

• Registration Number: NCT06011031
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2021-06-05
• Status Verified: 2023-07
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-05
• Study Completion: 2024-12-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novaloc attachment	Novaloc attachment	a newly developed device "novaloc attachment system"made of peek material and amorphous diamond like carbon.
locator 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

Primary Outcome Measures

Name	Time	Method
bone level change around implants	Through study completion an average 1 year.	measurement of bone height mesial, distal to each implant

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	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.

Trial Locations

Locations (1)

Prosthodontics Department Faculty of Dentistry Ain Shams University; 🇪🇬 Cairo, Egypt