Patient Satisfaction and Oral Health-Related Quality of Life of Quadrilateral Versus Bilateral Linear Bar Designs for Four Implant Implant-Assisted Complete Mandibular Overdenture Regarding Peri-Implant Crestal Bone Loss

For this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an Excel spreadsheet. Each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment.

The purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. The null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear).

According to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group I) and bilateral linear bar design (group II). Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.

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Key information

Conditions

Edentulism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heba Wageh Abozaed

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

have Angle's class I maxilla-mandibular relation
sufficient inter-arch space
a healthy, firm mucosa,
enough residual alveolar ridges in the mandibular regions to support implants

Exclusion criteria

neuromuscular disorder,
excessive smoking,
alcoholism,
parafunctional habits
systemic disorders affecting the bones
history of head and neck radiation therapy.

Treatment and study plan

Implant

Other

A long cone paralleling approach with a specially made film holder will be used to assess each patient's vertical marginal bone loss to ensure standardized radiography analysis and avoid any magnification errors. The linear distance between the proximal crestal bone level and the implant shoulder will be measured at the mesial and distal aspects of the implant measured in millimeters (mm). Measurements will performed using image measurement software patient satisfaction comparison between 2 groups

Primary outcomes

marginal bone loss

Time frame: Peri-implant marginal bone loss was evaluated immediately (T0) and after 2 years (T2) of overdenture insertion using a digital periapical X-ray.
Patient Satisfaction

Time frame: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Nov 4, 2024
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed