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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06673173
Enrollment
20
Registered
2024-11-04
Start date
2022-01-01
Completion date
2024-10-01
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulism

Brief summary

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.

Interventions

OTHERImplant

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026