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Two Versus Four Implant-supported Fixed Full-arch Prosthesis

Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290766
Enrollment
30
Registered
2022-03-22
Start date
2022-01-04
Completion date
2023-04-16
Last updated
2025-01-17

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

Conditions

Prosthesis Durability

Brief summary

The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

Detailed description

* Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department * All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University. The patients will be divided into 2 groups 1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the All on four concept. 2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to All On two concept.

Interventions

PROCEDUREplacement of four dental implants

placement of four dental implants according to the All on four concept

PROCEDUREplacement of two dental implants

placement of two dental implants according to All on two concepts

DEVICEmandibular full arch prosthesis

loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I

Exclusion criteria

* systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale (VAS) questionnaireone yearRegarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance

Secondary

MeasureTime frameDescription
Quality of Life (Secondary Outcome).one yearThe oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains

Countries

Egypt

Outcome results

None listed

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