Assessment of Novaloc and Locator Attachment Systems

Ain Shams University

Status: Active, not recruiting

Conditions: Completely Edentulous Maxilla

Treatments: Device: Locator attachment; Device: Novaloc attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT06011031

FDASU- Rec ID 032117

Details and patient eligibility

About

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.

Full 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

Enrollment: 14 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

14 participants in 2 patient groups

Novaloc attachment

Experimental group

Description:

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

Treatment:

Device: Novaloc attachment

locator attachment

Active Comparator group

Description:

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

Treatment:

Device: Locator attachment