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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inclined Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Novaloc Attachment

Group Type EXPERIMENTAL

Novaloc Attachment

Intervention Type OTHER

Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Novaloc attachments. The proper Novaloc abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.

Locator attachment

Group Type ACTIVE_COMPARATOR

Locator Attachment

Intervention Type OTHER

Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Locator attachments. The proper Locator abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.

Interventions

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Novaloc Attachment

Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Novaloc attachments. The proper Novaloc abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.

Intervention Type OTHER

Locator Attachment

Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Locator attachments. The proper Locator abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No