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EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS

A

Alexandria University

Status

Enrolling

Conditions

Inclined Implants

Treatments

Other: Locator Attachment
Other: Novaloc Attachment

Study type

Interventional

Funder types

Other

Identifiers

NCT05695612
IRB00010556-IORG0008839

Details and patient eligibility

About

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients should be completely edentulous.
  • Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
  • Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
  • The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Exclusion criteria

  • Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
  • Patients with active oral infections.
  • Patients with history of radiotherapy in head and neck region.
  • Patients with poor oral hygiene.
  • Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
  • Heavy smokers (more than 10 cigarette / day).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

22 participants in 2 patient groups

Novaloc Attachment
Experimental group
Treatment:
Other: Novaloc Attachment
Locator attachment
Active Comparator group
Treatment:
Other: Locator Attachment

Trial contacts and locations

1

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Central trial contact

Haitham Ismail, MSc

Data sourced from clinicaltrials.gov

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