Clinical trial NCT06011031: Assessment of Novaloc and Locator Attachment Systems
Official title: Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Completely Edentulous Maxilla
Keywords: implant overdenture
maxilla
novaloc
locator
peek
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: bone level change around implants
timeFrame: Through study completion an average 1 year.
Secondary outcomes:
measure: patient satisfaction
timeFrame: Through study completion an average 1 year.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Prosthodontics Department Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Hany Ibrahim Eid, Prof
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Noha Helmy Nawwar, Prof
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Ahmed Mohamed Osama, Prof
role: STUDY_DIRECTOR
affiliation: Egyptian Russian University
name: Fatma Fouad Sadek, AssistantLec
role: PRINCIPAL_INVESTIGATOR
References: